Claris Bio's journey toward treating neurotrophic keratitis

David Hutton, Managing Editor of Ophthalmology Times sat down with Claris Bio CEO, Clarke Atwell, to discuss the company's path toward developing treatment for neurotrophic keratitis.

Audio Transcript

Editor’s note: This transcript has been edited for clarity.

David Hutton:

I'm David Hutton of Ophthalmology Times. Welcome to the latest installment of EyePod, the Ophthalmology Times Podcast. I'm joined today by Clarke Atwell, founding CEO and board member of Claris Bio. Thank you so much for joining us. Tell us a little bit about your company.'

Clarke Atwell:

Thank you, David, thank you for the opportunity. Our company is a young company, we just recently emerged from stealth. Our founding technology comes from Harvard from Dr. Reza Dana and Sunil Chauhan's lab. And early, well, about four or five years ago, they were experimenting with mesenchymal stem cells, and they were seeing a salubrious effect on the surface of the cornea. And they were obviously intrigued by the activity othe cells but we're concerned that the cells themselves would not be a viable way forward for the treatment of diseases, given CMC difficulties and also dosing difficulties. So they went in and started silencing the proteins in the secretome that was being produced, and when they silenced HGF, that was the Aha! moment when the salubrious effects of the cells went away. So we closed our Series A in 2020. And with our partnership with a company in Japan called Kringle, we brought in our Series A and they brought in GMP material, we were able to submit our IND and are currently in our pivotal trial in Neurotrophic keratitis.
Your company's lead program is CSB-001 for patients with neurotrophic keratitis. Can you give us an update on it and its current status?
Yes, so it has been a while but we have completed enrollment in our trial. We have 131 patients, and we expect to have our top line data out in the summer of this year.

David Hutton:

And ultimately, what could this mean for ophthalmologists and the patients they treat?

Clarke Atwell:

Well, we see a lot of effects. So the activity of the drug, HGF, is a drug that modulates inflammation, it accelerates wound healing. Especially when we look at proliferation of epithelial cells, endothelial cells, nerve cells, and stromal cells. It also prevents, in animal models at least, prevents the formation of fibrosis, both fibrosis that is currently forming, but also fibrosis that has recently been formed. So we hopefully can regress scars. So we see many different indications potentially for the product. In neurotrophic keratitis, specifically, we're fortunate that our drug is very easy to use,. Patients will be able to keep it at room temperature, it's preservative free, and can be instilled in single doses and blow-fill-seal. The safety profile that we've seen from the product, we're very, very happy with. Obviously, we're masked to the AE rate right now in the study, but the overall safety profile is very positive. And so we see that the drug could potentially be used in more neurotrophic keratitis patients, because of its ease to use, ease to formulate, but also, more patients would be amenable to stay on the therapy because of the side effect profile.

David Hutton:

And what are the next steps for this program? Of course, you've kind of alluded to it, but could you maybe walk us through the timeline and how you see this unfolding.

Clarke Atwell:

So with positive data, and in the summer, we would begin another pivotal trial. This trial will be slightly different in that it will be slightly larger and will include both the US and European sites. We will also be studying BID versus QID. The study currently is QID. So we'll be looking at a different pathology in the next trial. And that trial should read out in the middle of 2026. We hoped then to submit for a BLA and look for approval early 2027.
And does Claris have any other therapies currently in development?
So we currently see HGF as sort of a Swiss army knife with multiple potential indications. So currently, we are enrolling a open label study in scar regression. So patients who have recently had a scar form in the surface of their eye within 5 millimeters of their pupil. We've enrolled 6 patients to date. Our target is 20 patients. We believe we will have top line data from that open label study in the same period as the NK. We've opened a trial and will begin enrolling in limbal stem cell deficiency. Currently there are no therapies, pharmaceutical agents to treat limbal stem cell deficiency. We believe that our drug might have a positive effect in that area. And that data will be towards the middle or late part of the summer.

David Hutton:

And lastly, what are your goals and outlook for Claris over the next year 2?

Clarke Atwell:

Well, given positive data, we're very excited to get the next NK trials started we've already started manufacture of drug for that and we'll be ready to go into the clinic. We're opening the regulatory files in Europe so that we can file in Europe and open up sites in Europe. And then given that we might have positive data from our either the limbal stem cell or the scar reversal, we're also looking to start a randomized control trial, after discussions with the FDA in either one of those indications.

David Hutton:

Thanks for listening to this episode of EyePod by Ophthalmology Times. If there are topics you would like to hear about, let us know. You can also stay connected with us on Twitter, LinkedIn or Instagram. We'll see you next time.