Become a Creator today!Start creating today - Share your story with the world!
Start for free
00:00:00
00:00:01
Ep. 29 Christian Kersten & Marte Cameron: From Serendipitous Discovery to a New Era in Chronic Pain Treatment image

Ep. 29 Christian Kersten & Marte Cameron: From Serendipitous Discovery to a New Era in Chronic Pain Treatment

Spark Time!
Avatar
68 Plays10 days ago

Neuropathic pain affects nearly 10% of the global population, yet effective treatments remain elusive. In this episode of Spark Time, we sit down with oncologists-turned-biotech-founders Christian Kersten and Marte Cameron of Akigai to hear the remarkable story of how a serendipitous clinical observation led to a new approach for treating chronic pain.

From the first wheelchair-bound patient who walked again after EGFR inhibitor therapy, to the 100+ patients who have since experienced life-changing relief, Christian and Marte share the science and the vision behind Akigai’s mission: to bring effective, non-opioid solutions to millions living with neuropathic pain. This is a story of discovery, persistence, and hope for one of medicine’s most stubborn challenges.

Recommended
Transcript

Introduction and Podcast Overview

00:00:00
Speaker
Welcome to Sparktime, where biotech's thought leaders, investors, CEOs, and industry experts break down the evolving story of life sciences. Hosted by Danny Stoltzfus and Will Riedel, two scientists and strategic communicators, we dive deep into how biotech leaders can shape the narrative, win investor confidence, and communicate breakthrough science in ways that truly resonate.
00:00:21
Speaker
From emerging trends and cutting-edge technologies to what investors and partners really want to hear, we go beyond the usual echo chamber, bringing you fresh insights, unexpected perspectives, and the strategies that set biotech's top players apart.
00:00:34
Speaker
If you want to sharpen your corporate messaging, decode industry shifts, hear from voices shaping the future of biotech, and get inspired, then you're in the right place. Let's get into it. Welcome back,

Highlighting Patient Recovery Stories

00:00:46
Speaker
Sparktimers.
00:00:46
Speaker
Today, we enjoyed incredible stories of patients actually leaving their wheelchairs or recovering their daily lives because of an incredible discovery in neuropathic pain. But just a warning, this episode does include some tears shed on the part of the hosts.

Introduction of Guests and Their Backgrounds

00:01:05
Speaker
Today we're joined by Christian Kirsten, who is a physician scientist with over two decades of experience in oncology and cancer research. He's the founder and CEO of Akigai, a company developing breakthrough treatments for neuropathic pain through EGFR inhibition.
00:01:19
Speaker
Christian has led clinical trial units, authored over 45 peer-reviewed publications, and holds a U.S. patent for neurological treatment innovations. He combines deep clinical expertise with a real passion for translating science into real-world impact.
00:01:33
Speaker
We're also joined by Marta Cameron. She's a physician, researcher, and innovator in the field of oncology and pain management. She is an inventor of the concept of using EGFR inhibitors to treat neuropathic pain.
00:01:45
Speaker
Of course, an idea born from their clinical observations and now being developed through Akigai, where she serves as co-founder and chief medical officer. Marta is also head of research at the Center for Cancer Treatment at Southern Hospital Trust in Norway and a consultant oncologist with nearly two decades of experience. Her work focuses on pain relief, palliative care, and improving quality of life for cancer patients through groundbreaking clinical research.
00:02:09
Speaker
So Christian, Marta, it's great to have you both here. How are you doing? Very well, thank you. Hello, LA. Fantastic.

Challenges in Neuropathic Pain Treatment

00:02:17
Speaker
Okay, so I want to start off on kind of a broad question because when most people hear that a biotech is working on a non-opioid pain solution, the immediate assumption is that it must be tied to solving opioid addiction. I think you know people tend to link those two words together. But Your work isn't about that at all. It's about addressing the real underlying issue of neuropathic pain, which impacts roughly, i think, 10% of the global population. So why do you think this massive problem has been so overlooked?
00:02:53
Speaker
ah Well, I wouldn't exactly say that it's been overlooked ah because a lot of effort has, in fact, been made to try to solve the problem of neuropathic pain. It's just that nothing has been found to work convincingly, really.
00:03:06
Speaker
um And you you mentioned opioid addiction and the opioid crisis has actually become an important additional motivator for us as we've kind of migrated in our work from cancer and into the pain field.
00:03:18
Speaker
But um the opioid problem or crisis, if you will, that I face in as an oncologist is that more often than not, opioids don't actually work in neuropathic pain ah or their significant side effects limit how useful they are in clinical practice.
00:03:35
Speaker
ah Because ah you said 10% of the general population, but 20% of cancer patients suffer from neuropathic pain. So that's more than twice as many as in general. um And I had to treat 10 patients with neuropathic pain with the existing drugs, including opiates, in order for just one of them, one of those tend to experience 50% reduction in pain.
00:03:58
Speaker
So that's not even complete pain relief. The problem is that all 10 of the patients suffer will with certainty experience side effects. Thank you. I would like to add another issue here overlooked. um As oncologists, we are so lucky that there are very many patient organizations and and voices and cancer is very present every daily life.
00:04:21
Speaker
But where are the 10% of the population that has neopathic pain? Where are they? don't know. Well, they I feel or we experience that when you have on a 10 point scale pain like four or five, if you you really complain, you really start complaining. But when the pain creeps up to seven, eight, nine, as often it is the case in neopathic pain, and even it becomes chronic, these patients become silent.
00:04:52
Speaker
They go to the doctor maybe once or twice or three times and then They get these drugs, as Marta said, that work maybe in one out of eight patients.
00:05:03
Speaker
The drugs make them tired, mood changes. So my feeling is these patients kind of disappear from society. They stop screaming.
00:05:14
Speaker
Well, I can also imagine, Christian, that if they're in that much pain, they probably aren't visible for a different reason, that they're probably at home a lot. they're probably It's probably hard to continue functioning in a kind of daily life. Is that something you've experienced?
00:05:29
Speaker
Exactly. That's what I mean. They disappear from society, not only from from work life, but also what we hear from the patient is that, and that's really kind of tough tough to to listen to is that the next of kin also kind of stop understanding or it's really hard. You don't see the pain, right? For the next of kin and spouses. So they they really become isolated.

EGFR Inhibitors: A Breakthrough Discovery

00:05:56
Speaker
So let's let's talk about your discovery and and that we're going to discuss today. And it was accidental, which is the most amazing part of the story, I think, in that my understanding is is that you were giving your oncology patients a variety of EGFR inhibitors for cancer treatment, and then suddenly someone along the way experienced relief from this neuropathic pain that you hadn't experienced before. Would you mind just kind of taking us back to that moment when that happened and Tell us the story around it.
00:06:29
Speaker
Yeah, thank you. I love telling this story. You have to rewind the clock back to 2007, actually, when EGFR inhibitors were quite new on the market, at least in Norway.
00:06:43
Speaker
There was this 62-year, I guess he was, ah old man. Coming into my outpatient oncologic clinic, he had a rectal cancer recurrence in his pelvis that was growing into his sciatic now nerve.
00:07:01
Speaker
And that was causing really terrible, and very well-defined and diagnosed neopathic pain. And due to this pain, he was sitting in a wheelchair because he couldn't move his legs. This aggravated the pain.
00:07:16
Speaker
And that in spite of high doses of opioids, He had gotten all oncologic treatment available before he was referred to me. And in the beginning, I was a bit hesitant to give him the combination of a neurotoxic chemotherapy and an antibody against the EGF receptor.
00:07:37
Speaker
Anyhow, I was ah kind of with a back to the wall and I gave him it. And... um
00:07:44
Speaker
When he came back to me two weeks afterwards, he came without a wheelchair, but with crutches. And I asked him, I was interested in the side effects of the neurotoxic chemotherapy I've given him, if this aggravated something. But when I asked him how he was doing, he raced from his chair, threw away his crutches, walked through the room, turned to around. And have to say, he's an engineer quite... um Yeah, and he he was crying, and I couldn't understand why he was crying.
00:08:18
Speaker
And I asked him for the reason, and he said, I'm crying because I can walk. I'm pain-free. I'm pain-free for the first time in three years. I'm not taking opioids anymore.
00:08:30
Speaker
He stopped taking 300 milligrams of opioids, and I'm asking him, when when did this happen? And he said, on in in the parking lot on the way out after the first treatment.
00:08:41
Speaker
So he had been pain-free for two weeks.
00:08:46
Speaker
I, back then I did not grasp the significance of of this. I was just delighted that he had not experienced more neurotoxicity and continued treating him against his cancer.
00:09:08
Speaker
But when I evaluated after some months with a new um MRI scan, I saw that the tumor was growing, but the patient was pain free. and And what we oncologists do when the tumor is growing, we stop treatment. And I did. And the pain recurred.
00:09:24
Speaker
And that was when I thought, okay, this it must be the EGF receptor inhibitor that is giving him causing him pain relief. And had some discussions with the leadership at the hospital who asked, is there any anything in the literature that could indicate your hypothesis?
00:09:45
Speaker
It was not. So And the nurses kind of supported me to try to give him it once more. And the pain disappeared.
00:09:56
Speaker
and And, yeah, then we, Martin and I, continued treating these patients on and off for for further four years.
00:10:07
Speaker
And every time we stopped, yeah he experienced the half-life of the drug, actually. He came back here. 12 days afterwards, and said the pain is back, and then he got a new drug.
00:10:19
Speaker
Wow. And so i mean, just imagining that moment of someone who's been wheelchair-bound, who's now, like, walking across the room, I mean, I can't even imagine how amazing that must have felt to be that patient. and And on your end, just, like, seeing it happen, I mean, that must be such a rare situation. and i I'm sure it inspired you to go on and keep treating other people because I think you've treated over 100 patients now for different types of neuropathic pain with a multiple numbers of these EGFR inhibitors.
00:10:58
Speaker
um What other stories do you have of of the of your discoveries here? um So Christian and I shared this therapeutic clinical practice at that time. And so we also we also shared the patients. So he would see the patient one time, I'd see the patient the next time.
00:11:13
Speaker
And so... I came into this after it had already started and was absolutely astounded by what I saw. And, and ah you know, oncologists, we have certain... ah clinical situations that

Expanding Applications of EGFR Inhibitors

00:11:27
Speaker
really you know set a mark on us because because they're so difficult and there are we dread them so much. And one of them is the massive pelvic tumor that that grows into pain, it grows into nerves and causes this type of neuropathic pain because you know we can all think back to four or five or six of these cases where where nothing worked and it just it is horrific.
00:11:49
Speaker
So I meet this patient who now has ah who's being ah totally palliated. i mean, he is he is off working on his his cabin in the forest.
00:12:01
Speaker
You know, as long as he gets his his refill every 12 days, he's fine. He's absolutely fine. And I thought, how can this be possible? i you know This is ah astounding. I need to tell the world about this. right like We can't sit here in this little small town in southern Norway and be the only people who know that this works. I need to tell people. So naively, I thought, okay, well, I'll write a case report. This was while I was working on my PhD, which is in symptom research. I was very focused on this.
00:12:29
Speaker
um and And so much more interesting than what I was working on my PhD was this. So I sat down and wrote the case report and really dug down and and and documented everything and and went through all these years of of of treatment for this patient. And then I got to the discussion section and had to hand the manuscript over to Christian so he could work in some of his molecular biology nerdiness there because I had no explanation for how this could be possible. I'm kind of a symptom-focused researcher and he he's more ah more molecular.
00:13:02
Speaker
So I handed the the paper back to him and said, well, you know, we need to publish this. Can you can you explain it? Right? And so... Yeah, and I i want to stress that it was kind of a lucky incident that both of us treated this patient and Marta did her PhD in symptom management and grasped the significance, whereas high did not. ah But when she handed me the paper and to it was a task to write a discussion, which was actually three years after treating the patient, that was the first time when I
00:13:38
Speaker
read about neopathic pain biology and and tried to understand it. And I and i remember where I was and i when I got goosebumps because I thought I understood it. And and then we made something important.
00:13:53
Speaker
Before publishing this case report, we actually... filed a use patent, ah which is not very usual in Norway to think of, but luckily we we did. And now we have been granted a very broad global use patent, ah which kind of is a foundation of Archegio, helps us bring this drug hopefully to the patients for the solution.
00:14:18
Speaker
So continuing on with that, like, With the other patients that you've treated, can you do you have any other sort of astounding stories like the gentleman in the wheelchair?
00:14:31
Speaker
since Since that time, um we have treated over 100 patients. and And across, you know, a lot of them have been cancer patients. um A lot of them the cancer patients are treated because of neuropathic cancer pain, right, like the first guy.
00:14:45
Speaker
um But then also, you know, 10% of cancer patients have non-cancer related ah neuropathic pain. So they have shingles, they have phantom limb pain, they have postherpetic neuralgia. So they have, or you know, pain.
00:15:00
Speaker
failed back surgery. They have you know all kinds of neuropathic pain. So every once in a while, we would give ah an EGFR inhibitor to a a cancer patient for to treat their cancer like we did with that first patient and then see that these non-malignant neuropathic pain entities ah disappeared, that they they reacted there too. But our second patient, so after our initial patient we were granted public funds to further explore this hypothesis.
00:15:25
Speaker
And so the first thing we wanted to do was to separate the pain relief from the cancer-targeted treatment to show that, okay, it's not, you know, Christian said that the the tumor was growing, but still the the treatment worked. So we knew that this was not cancer treatment causing pain relief. This was pain relief directly.
00:15:44
Speaker
So we went to our colleagues at the pain clinic and departments of neurology and orthopedics who see most of these neuropathic cancer ah heard neuropathic pain patients, at least when they are are very severe, and asked them to to refer the patients in whom nothing worked, that they had essentially been given up ah and and where the no treatment was working.
00:16:06
Speaker
um And the first of these patients referred to us was a 53-year-old woman who had woken up with excruciating pain and swelling in her one hand, a condition which eventually was diagnosed as complex regional pain syndrome, CRPS, referred to, is considered the most painful painful syndrome pain syndrome described.
00:16:26
Speaker
And before we met her, For eight months, she had been treated by doctors and lots of specialists and also had been ah at the at the tertiary care university pain clinic in Oslo without any relief.
00:16:39
Speaker
So her pain was constantly nine to 10 on a 10 point scale. And she was, like we described earlier, totally isolated at home. She couldn't sleep. ah She was becoming suicidal. Those are her words, not mine. But um and so she came to...
00:16:55
Speaker
the outpatient clinic and had actually kind of created a shield around her hand in order to protect it from because even the slightest air movement, for example, if someone would walk briskly past her, the the movement of air would make the the pain even more extreme.
00:17:12
Speaker
um So she was the first patient ah without cancer that was given an EGFR inhibitor for her pain. ah and And we did so on a Friday. And on the Saturday morning, she called and that and said that she was out driving her car pain-free.
00:17:27
Speaker
I mean, before this, you couldn't touch her hand. So she is absolutely over the moon. And that was 13 years ago. and And we still treat her. But now we've gone over to, you know, a lot has happened during these 13 years, and we've tried her on different types of EGFR inhibitors to see what would work best and what's most, you know, it's not easy to travel when you're when you need infusions regularly. So she's now on pills and has been for many years. so and And you ask, yeah.
00:17:56
Speaker
what it has meant for the patients. And um and she' so she claims that it has saved her life and and i I think that actually might be true. um So she's she's kind of our longest and a patient that's been treated the longest.
00:18:11
Speaker
um But but therere you know for each individual who experiences this, it yeah it's it's amazing. they They kind of lose hope, right? they They've tried this, they've tried that. everything yeah People don't believe them.
00:18:25
Speaker
you You can't look at them and necessarily tell that they're in pain. When it's chronic like that, you you like you said, you stop screaming out loud. you can't you can't do that. Yeah. so So when finally something works, it is absolutely life-changing.
00:18:41
Speaker
Another case that that kind of illustrates things a little bit differently too is um was a single mother of two small children. um She had actually cancer, cervical cancer, end-stage metastatic, um and her pain was so severe and refractory to all treatments that she actually had to be ah administered continuous spinal analgesia in order to control it. This is something that we see often um and and required such high doses of spinal analgesia that she became paralyzed, right? So in order to have control of her pain, she had to be paralyzed from waist down.
00:19:13
Speaker
um And it's pretty intensive treatment. She was in the intensive care unit receiving this. It's invasive. And for someone with with end-stage cancer, this is the rest of your life. It's never going to turn around. It's never going to get better.
00:19:24
Speaker
So she was never going to be able to walk again. And probably worse in her case as a single mom, she was never going to be able to be at home with her children again. and she had very limited life and expectancy.
00:19:36
Speaker
So we started EGFR inhibitor ah on her while she was in the intensive care unit. and And the next day already, we dared to, we probably could have gone faster in hindsight, but we dared to reduce her spinal analgesia by half, ah which reversed the paralysis. So then she could walk. And within three days, we had her all the way off the spinal analgesia, and she could go home.
00:19:59
Speaker
So she was discharged and and was able to celebrate her last Christmas at home with her family. So although it didn't save her life, it certainly did mean mean a great deal for her and and for all those around her. So those kind of things just, you know, if you if we ever get frustrated and feel like, oh, you know, this we've had a lot of a lot of windmills and uphill battles.
00:20:21
Speaker
um If you think about this, then then it's easy. It's easy to to to keep pushing on. Yeah. Wow. Yeah, that's a really hard story to hear. Being the mother of three young kids, like I couldn't even imagine how meaningful that was to her. Yeah, you've you've both just shared such incredible stories of, I mean, from the patient perspective, to be able to...
00:20:44
Speaker
return at least in part to your your regular life must mean the world to them.

Mechanism and Advantages of EGFR Inhibitors

00:20:51
Speaker
But also from, I'm sure, a clinical perspective, this is something that people dream about is to have something in the pharmacy that you can treat people with. It's it's already been proven um you know safe. It's been approved.
00:21:04
Speaker
um I have so many questions. I
00:21:09
Speaker
I guess what they all boil down to is, you know, how does this approach actually work? what What is the involvement of of EGFR and inhibiting EGFR? and And why does that reduce pain? I get the sense it's not about, you know, tumor shrinkage.
00:21:23
Speaker
So in simple terms, why do you think EGFR inhibitors succeed where decades of ah pain innovation has failed? I want to shoot in here that we were ah lucky or throughout the years not only to treat these single patients, but also to test it in some in two prospective trials, also in placebo-controlled proof-of-concept trials. And therefore, we were able to see
00:21:54
Speaker
how rapid the onset is, how the duration is, how it harmonizes with the pharmacology. and And that's important to answer your question about the mechanism because the main mechanism is in the periphery of the nervous system. You have the central nervous system, of the brain, obviously, and the spinal cord, and then you have the peripheral nerves. And it's often a discussion where the pain is generated or perpetuated. And um what we then could, the rapid onset very strongly indicated ah mechanism in the periphery
00:22:39
Speaker
And what we and on our our colleagues ah could show and and later also other groups could show is there are several mechanisms in the periphery in ah in on on the damaged nerves. But the most important thing is that the EGF receptor is expressed on pain fibers, but it becomes activated after damage.
00:23:06
Speaker
Then the EGF receptor becomes active and a receptor that becomes active ah sparks ah a lot of things intracellularly. But what we believe is the most important part is a translocation of ion channels on the damaged peripheral nerves.
00:23:28
Speaker
And ion channels have been the focus of pain research for more than 20 years. There have been 400 clinical trials. People have tried to to develop ion channel inhibitors.
00:23:41
Speaker
but But then again, you have the problem that you in inhibit these ion channels in the entire nervous system, ah including the central nervous system. So essentially, you do the same thing as you do with the current drugs. You shut down the entire nervous system.
00:23:58
Speaker
But what we see with this EGFR receptor inhibitors, they are only active on the damaged peripheral nerve, and they do not only affect one ion channel, but several.
00:24:12
Speaker
In our rodent model, it was at least three ion channels. Actually, today I read a new paper that came out last week. There's a false ion channel of that is ah that is affected by the EGF receptor on damaged nerves. So so what I believe is that the inhibiting one ion channel is not enough, but the EGF receptor affects all of them. And therefore...
00:24:43
Speaker
we see these huge effects. so We see a response rate of 70%, 7 out of 10 patients respond, and the pain totally diminishes. so And I think this is due to ah that several ion channels are affected.
00:25:02
Speaker
I think important too, though, is is the fact that this happens only in the damaged nerve, right? So ah it's only going to target the pain where the pain is, um whereas the other you know other methods of of affecting these ion channels that is going to is going to cause a central nervous system ah side effects, whereas here you're working in the periphery, and so you don't get the...
00:25:25
Speaker
the um you know, the opiate um or and anti-epileptic drug side effects that you see with with the ones that are currently in use. So it seems much cleaner.
00:25:38
Speaker
ah You know, our patients say that they they were in a daze. I was in a daze with these drugs. the drugs I took the drugs because because, you know, I was prescribed them and really because they...
00:25:49
Speaker
they gave me some distance to the pain. The pain was there. it never helped the pain, but it removed me from the pain when they described why were you taking ah opiates or anti-epileptics for your neuropathic pain if it didn't work. Well, it did remove me. So then we transfer them to EGFR inhibitors. They stop their other pain medications and suddenly their CNS side effects abate.
00:26:16
Speaker
So... Wow. So I guess my next question does you know is this how does this How does this relate to the rest of the pain innovation field that's been going on? I mean, is is this does this link?
00:26:32
Speaker
It seems like this links really nicely with the way that we understand pain to me and that we're um now you're youre you're showing that if you inhibit selectively EGFR only on damaged pain fibers,
00:26:49
Speaker
that you're having a really strong effect and it's, it's it's hitting multiple, uh, ion channels. I mean, what, what have we, how does this fit with our current understanding about neuropathic pain?
00:27:02
Speaker
Um, I, I think in, we are just oncologists, right? We are not, uh, we are self-made, uh, pain researchers and, and what, uh, uh, but what we kind of learned by reading the literature uh,
00:27:18
Speaker
as i I want to mention two two points. One is a central nervous system versus a peripheral nervous system, and and the other thing is all the molecular targets in the pain field. So when it comes to to the central versus peripheral, we learn there's a lot of debate where chronic pain is perpetuated. Is it okay it's generated in the periphery, but in chronic pain patients,
00:27:44
Speaker
People often, but they couldn't believe that we could relieve patients like the two patients Martin mentioned who had been in chronic pain for months and years within hours. How is that possible? Because you have these central mechanisms that perpetuate the pain.

Innovations and Challenges in Pain Research

00:28:02
Speaker
so But this is something to do for for the pain field in the future to to show, at least in some patients, as we have seen, you can totally reverse the the symptoms by targeting the periphery.
00:28:17
Speaker
And the other thing is all the molecules that are, I mean, if you read the pain paper, there are so many pathways and receptors and molecules that are believed to be involved, but they Many, many of them are kind of connected to the EGF receptor. There are many papers connecting them.
00:28:38
Speaker
But in the end, I think it ultimately comes down to ion channels. And then some try to inhibit this ion channel or... Some try to inhibit that ion channel. So what we believe is this is that, again, as I said, that not inhibiting but translocating or modulating several ion channels is is a key. so um i think that the And also the second patient, Martin mentioned, the patient with a complex regional pain syndrome,
00:29:16
Speaker
The pathophysiology has never been really understood of that disease and is also still not classified officially by many as a neopathic pain disease. we We believe also or hope that research into this type of disease will be motivated by all our findings in the future.
00:29:38
Speaker
Yeah, that kind of, you know, leads me into a ah question that I've been thinking about as you've been talking, Christian. And we know there hasn't been a whole lot of innovation in pain over the last 35 years. In fact, it's you could almost describe it as a ah desert, right? no No one wants to go near it. And i i know from, like, you know, talking a lot with investors that pain's often like a no-go zone. And I'm wondering...
00:30:04
Speaker
given what you just said, is is it because we just don't understand the cause of pain in order to be able to address it appropriately? Do you think um there's some truth to that?
00:30:17
Speaker
Yes. Essentially, yes. I mean, there have been only in the ion channel inhibitor fields, there have been 400 clinical trials that all failed. And so the entire industry, both the biotech pharma industry and the investors kind of pulled out and for almost two decades, I would say. Not not entirely pulled out. There been some actors who who have tried and tried and tried.
00:30:48
Speaker
But the last drug approved actually was in 2004. So that's a long time ago for such a huge chronic field. But my feeling is we had now some proof of concept that there have been the first positive trials for inhibitors of single ion channels. And there's some at least proof of concept, although these drugs are not overwhelmingly effective, but there's some proof of concept.
00:31:19
Speaker
And I experienced some renaissance in in the field.

Akigai's Vision and Strategic Plans

00:31:25
Speaker
Mm-hmm. Yeah, I mean, i hope i I would hope that this, you know, inspires people to look further into pain and understand it more because it is such a chronic problem. I mean, I personally don't have this issue, but I can only, it's kind of, to me, it's almost like, you know, just as many people or pieces have pain or something like that. You know, it's like such a huge health issue. we I really hope this inspires more people to pay attention and address it.
00:31:57
Speaker
That's amazing. And, you know, in in that vein of of getting more people to adopt this approach, looking ahead, what is your vision for the company for Akigai and for patients worldwide, if if it is adopted more broadly?
00:32:15
Speaker
ah you ask two questions now. What is the vision for for the company and what is the vision for the patients worldwide? And ah as I said, the first patient was in 2007. Martin and I wanted to continue as oncologists and we never...
00:32:31
Speaker
envisioned establishing a company, but also as you understood, these patients made so much impact on us that we finally, ah when when this entire concept came into our circle of influence, we we feel privileged and gladly embarked on this this journey. But our mission mission is very, very clear. And that is bring an EGFR inhibitor to as many neuropathic pain patients on this globe as fast as possible.
00:33:02
Speaker
And this kind of defines ah the mission for the company or the vision for the company. we We have used actually six different EGFR inhibitors in the clinics.
00:33:17
Speaker
We screened 68 EGFR inhibitors that have been tried to to be developed in oncology, but for some reason or another were shelved after phase one or two.
00:33:29
Speaker
And there's one particular EGFR inhibitor that stands out for for and for quite well-defined reasons. And ah we are repurposing this EGFR inhibitor tablet and talking about a red flag of neopathic paint also for some investors ah repurposing as a red flag. So therefore, a lot of our...
00:33:57
Speaker
ah activities have been aiming at securing market protection for such a repurposed drug. and And we we went down that road because this is really the drug is safe. We can reduce the dose and we know it works. So therefore it's a very, very risk reduced, very fast road to the market.
00:34:21
Speaker
um At the same time, we also develop a we we have ah good reason to believe that this drug could be improved upon, and we are also developing a novel antibody on that.
00:34:34
Speaker
And that brings me back to the second part of the question. What is the vision for the company? ah That depends very much on how do we solve the vision for the patients? We want now to start a pivotal trial in complex regional pain syndrome.
00:34:54
Speaker
There has never been a drug approved for that type of disease. It's the most ah detrimental pain disease, as Martin alluded to. And we were granted orphan designation by EMA and FDA.
00:35:12
Speaker
70% of our patients with CRPS treated have had dramatic effects. So we think this is a very good stepping stone to to delve into all these neuropathic pain diseases.
00:35:24
Speaker
medication And now we are looking for funding for that trial and we have several roads we could and employ and and one would be as a normal investor road. But we are also already contacted by several pharma companies, both ah regional and global pharma companies who want to in-license that solution.
00:35:52
Speaker
And we... will choose the direction that is the most secure and fastest one for the patients, either if we partner with a pharma company or if we partner with a larger investor consortium.

Communicating Innovations in Biotech

00:36:09
Speaker
Wow, that's great news for the patients. And I have ah a follow-on question around that because I heard the word red flag in there a couple of times. And as someone who thinks about communicating stories and getting people to understand the impact. I mean, obviously the science speaks for itself and what you've done with the science is incredible.
00:36:33
Speaker
But I'm curious, have you ever faced difficulty in communicating the story from your perspective in that you're two oncologists who've turned into biotech innovators and,
00:36:49
Speaker
um how how do you How do you tell that story? Tell me about how you think about that. That's a very interesting question. And people often to tell me, oh, your pitch deck needs to be like this or it needs to be like that or make it this.
00:37:04
Speaker
Not often, Christian, always tell you.
00:37:11
Speaker
And I can tell you it depends so much on the person you are talking to a and on the background of the person. um it's it's kind of hard to believe if you if you talk to to a person in the street and say, here we have a high unmed medical need and we have this solution that works so dramatically, people say it's a no-brainer. I mean, you can make money you can make money if you have a solution for such a huge problem.
00:37:38
Speaker
ah And but But then it comes, okay, you need to protect the drug. But we have regulatory protection, we have an orphan designation, we have a broad use pattern, we have dose differentiation, we have a reformulation, we have lower doses.
00:37:50
Speaker
So we have a lot of protection. and but But I think the the the VC world is is more checking the boxes. So there are some challenges and they have to defend it then to their committee.
00:38:03
Speaker
I actually find it easier to talk to to pharma companies who are marketing drugs, who are used to that type of ah protection mechanisms. um So that's much more easy.
00:38:19
Speaker
Yeah, it's interesting because, i mean, the two of you have been doing this since you first made this discovery 17

Acknowledgments and Community Support

00:38:26
Speaker
years ago. I'm doing the math right. that right? 18 years ago.
00:38:31
Speaker
It's like where on the planet are you going to find two oncologists or two people that are going to be so so dedicated to a cause? I mean, if I was an investor and I saw a team that was that dedicated to solving a problem that they put their other life on hold to do it, I mean, I would invest in that. To me, that's...
00:38:53
Speaker
something that's rare and um really special. So I just wanted to to say that because it's not all the time you meet people that have done what you two have done. Oh, and we do. We have we have a lot of people who support us and investors, family investors and whatnot, who see that and who appreciate the stories and and absolutely and back us and believe in us. And I mean, essentially, you know, this was a serendipity. And and like you said, it happened to be the perfect combination of, you know, ah you have to share the patient to be able to talk about it and to to wonder and to, you
00:39:27
Speaker
this kind of thing we have We're coming from totally different backgrounds in terms of where we are in medicine, our interests, and our focus. We have a patient who over a long period of time could be observed over and over again. So, I mean, it worked out to be the perfect storm and we just shook it up and here we are with the solution to neuropathic pain essentially.
00:39:47
Speaker
And I think, ah you know, we we're we're trying to, to you know, ah we or we' we've been forced kind of to to make this a a business ah ah type approach. but But, you know, we're we're we're being ourselves, you know, we're we're telling the stories, we we we admit to our to our shortcomings and where we need help and and what we um what we can and what we can't do.
00:40:14
Speaker
ah But the point being, the drug works. We've seen it in patients. And and that brings us that we're at a totally different place than other biotechs that have been, you know we've existed for what now, two to and two years or something like that?
00:40:27
Speaker
You know, we're we're in humans. we've we've You know, these drugs have been used for over a decade. So they're safe and and we know they work. so So we're just trying to be ourself and be be straightforward. And and definitely um we are reaching people too. Yeah, absolutely. Yeah. Wow. I mean, i i love that you're being yourself and I love that as, you know, two scientists at heart kind of found a discovery and just pursued it. i mean, that's the essence of why I became a scientist was to make those serendipitous discoveries and see where they led. So that part of this story really inspires me. Yeah. And and one thing is ah then family investors who are backing us and people are believing in us, but what was really
00:41:11
Speaker
kind of heartwarming is how the pain community, the international pain community kind of embraces us. I feel our, and when, when we had this first observation, we went to the pain Congresses and said, okay, we need to tell these pain researchers, they need to take, take it on.
00:41:31
Speaker
ah But then we learned they pushed back and said, oh, this is nothing for us because the drugs are too costly. These are cancer prices. We cannot do research. and So we were working for Big Pharma and Big Pharma was not doing it. So when we finally started the company,
00:41:47
Speaker
It was really so easy and we feel so privileged. ah The contact we got to the, I would say, the A-team of neopathic pain and CFPS research, but also on the regulatory side, when we are engaging with the FDA, now we people take us for who we are and really want to help us along

Conclusion and Future Episodes

00:42:11
Speaker
the way. And they they also are kind of enthusiastic.
00:42:14
Speaker
They like the story. Finally, something happens. I mean, we are together with pain researchers who have been involved in hundreds of trials and then they hear suddenly about this story and then and man yeah it's it's really we feel welcomed by the community that's that's also very motivating just an incredible story and and thanks for coming on the podcast today to both of you for sharing this incredible story and and how you're advancing such important
00:42:47
Speaker
therapies for for people who really don't have any other options. So um I'm sure our listeners will really appreciate this one. So thanks to you both. It's been a pleasure. Thank you for having us.
00:42:58
Speaker
Well, thanks again to our listeners for joining Sparktime. We welcome you to join next time as we continue to explore the ideas, the thinkers and the innovations that drive biotech forward.
00:43:08
Speaker
We hope to see you there.