Episode 107: How Hearing Loss Research Is Shaping the Future of Neurodegenerative Health

On this episode, when we say listen in, we really mean it. Learn about hearing loss on this episode of BIO from the Bayou. You're listening to BIO from the Bayou, empowering biotech leaders with the tools, assets, and expertise to improve healthcare outcomes.

Each episode provides insights and information to expand your network, advance your product line, and help your company thrive.

Serving the entire Gulf South, but recorded in the heart of New Orleans. Welcome back to Bio from the Bayou. I'm your host, Dr. Elaine Hamm, the executive in residence at Tulane School of Medicine. And today's guest is Celia Bellin. She's the co-founder and CEO of Silkare, a biotech company dedicated to enabling the early detection of neurocognitive disorders and the treatment of the associated auditory diseases. Welcome to the show, Celia.

Oh, thank you, Elaine. I'm very happy to be with you.

Yeah, it's nice after these many years too that we have been friends and colleagues in this very Well, I wouldn't say it's a niche space because the aspects of neurocognitive disorders and hearing disorders are a pretty large market, but there are very few that specialize in hearing disorders and understanding the testing of auditory disorders and the treatment of them. So I would love to learn a little bit more of how you have built a career on this very specific area in the founding of Silk-Care. What inspired you to take the leap into entrepreneurship?

So it's a second career, I would say, because I started working in the pharmaceutical industry back in 2000. That was my first job. And I worked for a big pharmaceutical company for 15 years before I co-founded and become the CEO of CellCare. The last 5 years within this big pharmaceutical company, my associate and me, we were all 3 working in what they called the therapeutic strategic unit focused on aging.

Yeah. Yeah.

And our goal was to look at the aging people on a holistic manner, not only treat one disease they have, but really look at everything so that they can age well. So this is still something I think that some pharma companies are trying to pursue. So let's hope they will continue. And among the different diseases, the sensory disorders were also assessed. And we were trying to look at both the vision, the ear, the tests. So everything was actually looked at in order to see whether the pharma industry could propose solutions to improve the degeneration of those senses with aging. So we were specifically focused on this, but not only. And that's how I came to hearing, actually. At that time, I was working with the commercial operation as well in Europe, even if I was an R&D girl. And it was very clear that there was a huge unmet medical need in hearing loss. No treatment, no real, I would say, innovative approach to develop drugs in this field. And we thought, my associates and me, that we could do something in the field. So that's why we left the big company and we co-created Cellcare.

And how long ago was that? I'm just trying to think through the timeline.

It was 11 years ago.

Yeah.

Yeah.

Well, and it's funny, it feels like aging, healthy aging has become sort of this hot topic. So that's a good thing. We are realizing how interconnected all of those things are as we think about dementia and hearing loss, the impact that hearing loss can have on causing additional symptoms and progression of dementia has been, I wouldn't say it's new, but I feel like it's been better thought out. I mean, probably 10 years ago, we really didn't understand that piece of it and how they were all interconnected. And I also found that understanding the eye, I feel like the eye field has been a little bit further ahead in terms of models and drug development. And we've taken a lot of lessons from ophthalmology as we start to think about how we're going to deliver things to the ear as well. And so I love that you're combining all 3 of those aspects into one because they're also very interconnected. So let's talk now a little bit about Silk Hair. You've started out with one business model, but it seems like you've been changing a lot over the past few years. I'm excited to learn more of how that change progressed.

Yeah, sometimes you change to survive, you know?

Oh, honey, I know.

So it's, well, we started a business. So we left Sanofi, which was the big pharmaceutical company we were all 3 working for. And we co-created a company where the market was not really there yet.

Yeah.

So we could not raise money for any drugs at that time. was impossible for us to bet on one mechanism of action, one drug asset, one modalities. And it was too risky for us. We needed to get paid to be able to— that was as simple as that. So when we started, we knew we wanted to work in hearing. And so we looked at— I will tell you the very beginning of the story that I don't think I have done before, but we looked at different business models, lots of business models. And it could even be at that time rebranding drugs that were already on the shelves of the pharmacy for otic applications. So we looked at many things, even how we could work on better understanding how the sound, what the impact of noise, you know, we looked at, I don't know, 10 different business models.

Yeah, I was like, that's a lot of different business models you have to consider.

Yeah. And what was the really something that we thought we could do and that was lacking into this value chain to bring drugs to the market and provide therapeutic solutions to patients was this preclinical work. So in between the lab and the clinical development, there is something that usually you find in any therapeutic axis that was missing in hearing. There was no company doing preclinical development.

You were—

you had a lot of academic doing great work, by the way, but academic is academic. You, you're not there to scale up the model that you have developed and test. a lot of drugs in a reproducible manner to select the one that can go to clinic. You're not there to assess according to FDA guidelines, the toxicity and the tolerance of all those assets before they are administered to humans.

Yeah.

So this type of things were— was clearly missing at the time we created CellCare. And for us, it was one barrier For the drug to reach the patients and then the market, hopefully. So we said, this is something we can do actually, because it was development we were really good at. It was about people management, putting process together, acquiring techniques, being advised by the right people who really know the field for, or had known the field for many years.

Yeah.

So we had lots fathers, we call them like this. That's a good description. Mothers as well, maybe. But, you know, those who were in the field for 30, 40 years and had lots of knowledge to also share with us and with others so that we can succeed, especially Yves Cazal, who was one professor that has been working with us since the very beginning. And so, and then it was about, you know, really this people management, how you attract talent, how you train people, how you make them enter into a company where you will have a culture that guarantee the quality of the services, because initially it was really that, that you can provide to others to accelerate their development to patients.

Yeah.

And you have sort of 3 different divisions, is that right? You have the SilkCare External Innovations, you have SilkCare Therapeutics, and then you have the Auditory Analytics Division. So what do each of these do and then how do they contribute to your overall mission?

So the External Innovation is actually this initial business that we started by positioning repurposing drug in hearing. So we tested drugs for several companies that wanted to have a look and explore a little bit this therapeutic area. So I think Celcare really contributed to increase awareness about hearing loss, but also give a new tool for those who want to look at this field because they knew that if they come to us, they could have their compound tested and advised and look at the dose and everything we do. So this helped us to generate revenue. More and more it became, That's why it's called external innovation. It became, you know, an R&D platform with deep expertise in the ear, including microsurgery and injections, implantations. So we do lots of things like that. It becomes more and more a platform that uses research agreement deal with companies. So it means that the company, they come to us, we have a project for about 3 years with them. We put resources and people that manage the project for them and we bring their program from A to B to C with, you know, go/no-go decision along the way that enabled them to take their own decision also. So this is still there. In 2020, we had decided to in-license compound ourselves. Initially, it's, you know, pharmaceutical. I'm a drug developer.

Yeah.

My background is in clinical development and project direction. So I'm the one, not only me, but my job was to, and my study was to have a compound from entering development to the market and the different steps and coordinating the different steps to do that. But it's super hard to develop drugs. And so—

That's a bold mission there to go all the way from very beginning all the way to a product. I usually like to hand it off sooner, but good for you.

Especially with no guidelines yet, no success or very few yet. So you cannot copy and say, I'm going to do the same as you did because it's perfect. You cannot, you cannot bear on guidelines that would have been written by regulatory. So you're like blind and you navigate.

Lessons learned from failed experiments and failed companies is what we have ahead of us. And that's been the biggest challenge is that you were kind of on our own only with like, well, don't do that. Not, we can do, if we do this, we know that we can get to this stage. It's more like, well, let's not do this. And that's so hard.

It's hard, but we can be very thankful to those companies, even if they have failed, because if they had not tried, I mean, there's always someone trying first. And unfortunately it's not always the one that succeeds, but it really helps the other companies. So we, we have to be very thankful to those companies.

Yeah.

So it's hard. So when we decided to in-license compound, it was a decision that we all agreed on within the company, but that was a huge decision for us. There was one reason why is that we had to also prove somehow that we would be able to understand what was after this preclinical phase, and we could also innovate and bring new pathway Yeah. To develop drugs in this field. We tried with our partner, but they were not necessarily, you know, listening because they think, well, you're in preclinical, you don't know what is in clinical, which was not really true. So we had to have a drug to raise money and to be able to prove that there are maybe new clinical paths to develop drugs for those hearing diseases. So that's how we created CellCare Dep, which is the therapeutic part that you were talking about. And the data analytics is something that had to be also developed as a tool because one of the barriers to demonstrate efficacy of a drug in a clinical setting is about the data. You need to understand what size effect can have your drug. You need to be confident with the baseline that you do on patients. So the measure, you need to select very carefully the clinical endpoint in your clinical trials. So there are several things that bear on the data currently and the quality of the data that you can collect and the type of data that you will collect as well. So we— this was not existing in the literature.

Yeah.

At the time we wanted to start clinical development, so we had to produce those data. And that's why we started to collect data in clinical observational trials on a lot of patients, on subpopulations of patients, where we had that notion of characterizing the hearing of those patients. This was for us the only way to increase as much as we can the probability of success of a drug in phase 2.

What I love about that story is it's really a story of finding a need and fulfilling a need too. I mean, you as a company were trying to figure out what business model made the most sense and trying to have shelter and feed your families and a way to support yourself. At the same time, the pharmaceutical industry needed a better way to understand the impact of their drugs on hearing disorders or their impact of their drugs on ototoxicity, which can cause— some drugs can cause deafness. So finding that sort of piece of it and then really understanding the huge gap that we have in hearing disorders and the lack of therapeutics.

Yeah.

And finding a way to fulfill that aspect. And then this auditory analytics, taking advantage of the amount of data that we have in the field, good and bad, especially the bad, because that's how we can start to learn and develop better processes. And so I really love that. At the same time, your business also needed to— you got revenue from those early service pieces and then bringing in the new therapeutics, helping serve that piece of it. So I love the evolution of the company and also sort of the way that you've fulfill different needs in our industry of hearing disorders and related disorders. So, so kudos to you. That's a pretty hard thing to do, especially in that, in an industry, even though the market is large, it is such a specialty. And it is really hard to be the first in that area too. So, so congrats on that.

Thank you. Thank you. What we've been very careful at as well is to try again not to copy something that, or reproduce something that was already existing. For us, it was clear that, for instance, there are several companies in gene therapy right now trying to address inherited hearing loss, and they are great companies. I mean, there was no reason for us to go on that specific area. The objective for us was to go where there was nobody yet.

Yeah.

And cochlear synaptopathy, early stage of hearing loss, based on what we used to do, which was, you know, working on this therapeutic unit of aging back at Sanofi, looking at preventing major chronic diseases linked to aging. The cochlear synaptopathy was actually obvious for us as a way to demonstrate that we can bring therapeutics for preventing hearing loss epidemics. And that's what really the objective of the company. And yeah, so that was new as well.

And you've recently done, I guess not recently, but you've done a deal with Shinogi. Is that correct? Yeah.

So it was last year, 2024. So yes, we did a deal with Shinogi on 3 different aspects. One is an option license or on our 2 main assets right now, SEAL001, SEAL003. So onco-clearance. The second thing was we raised a Series A. So in total, it was $40 million that was secured last year for the development of those assets. That's the main item. And a research agreement as well. So we had 3 different deals with Shionogi, which is a very good partner for us. It's a partner that sees hearing loss as well as starting point of a cascade Of degradation linked to aging. So for them, addressing hearing loss is something that will prevent the progression and the aggravation of many diseases. You were talking about dementia because this has been published, and I think people start really to understand that the earliest they will treat their hearing problems, the more they will protect their hearing, the less chance of having cognitive impairment progressed to dementia they will have. So that's something very important.

Yeah.

Very important. But it's not only dementia. That's what we think. There are several other diseases that are linked to auditory problems first.

Yeah. Well, so you've evolved business models, started your own companies. You've done deals that are multifaceted with a mixture of fundraising. You've done deals with large pharma. Many of our listeners are biotech founders and entrepreneurs themselves. What piece of advice would you give to them on any of these topics?

I think where we've been the most successful is to always look out of the box. So it seems very cliché. It's true though. It's true. But if you try to copy and paste always a company in hearing, it does not work yet. So you always need to find new ways. New avenues for for the success. So that's what we've tried: take a step back and get inspired by other therapeutic area, other field, not only pharma, to see what the others are doing and how they develop their own company in the tech, for instance. That the data part, I mean, is something that is obvious in many other, and it's still it's not obvious for all the pharma company. which it should now. I mean, we can't do without. So it's important, the quality of the data, how you collect that, what you measure. In biotech, this is the most important part because there are a lot of drugs that never reach the market because you did not choose the right endpoint and you did not measure the right way the effect of your drugs. So it's very important to take care of the fundamentals.

I would also add that one piece of advice I would give founders about you is one thing I've always really admired about you is how collaborative you are and how dedicated you are to helping the field as a whole, that you're not just focused on getting your business revenue and making your money. And that's the only thing that you are focused on. What I have really admired about you is really pulling together this very sort of niche field, but also There's always, you know, people that have different opinions in a field. And so what I've really admired is that you've, you really have brought us together with the goal of moving this forward and helping patients. And so if I were to give founders advice, it was, is to be like Celia and think beyond just yourself.

So. But thank you. This is really very nice to hear. And I think that's how you can go. So one thing that we really need to get rid of is that mindset of thinking that your success relies on the failure of the others.

Yep.

And that is very important to understand. I mean, we have 20 patients per day who write to us True. And they even call me. I don't know how they find my phone number. They are in distress. They are looking for solutions. And so if you think you're the only one that can provide this solution, you're wrong. It's wrong. There is, I mean, if everybody succeeds, that's the best thing that can be for the patients.

Absolutely.

Yes.

You don't have to step on others to get to patients.

No.

And these patients are desperate, and that should always be our mindset is how can we help them the best? And if you have a drug that isn't at market yet, go work them in someone else's program and their clinical trials and be willing to learn from each other, the good and the bad. Well, Celia, thank you so much for joining us. We'll be sure to keep an eye on what you're working on. And if you, as always, we'll have our contact information of Celia and CellCare and informational links posted in our show notes. Make sure you check them out to learn more. And thank you once again for joining us.

Thank you very much.

Thanks for joining us for Bio from the Bayou, and we hope you'll join us again.

To never miss the latest updates in biotech, hit the subscribe button now.

We'll catch you on our next episode of Bio from the Bayou.