In a new episode of The Ophthalmic Project, Mark Dlugoss speaks with Joshua Moriarty, CEO of Okogen, to discuss a new product in development for infectious conjunctivitis.
Mark Dlugoss:
Healthcare providers treat about 10 million cases of infectious conjunctivitis annually in the United States alone. About 60% of those cases are viral, and the other 40% are bacterial. However, there’s currently no approved treatment for adenoviral conjunctivitis.
Hello, this is Mark Dlugoss, Senior Contributing Editor for Ophthalmology 360, and welcome to The Ophthalmic Project, powered by Ophthalmology 360. In today’s edition of The Ophthalmic Project, we learn about a new treatment for acute infectious conjunctivitis that is currently in development. The company developing this drug is Okogen, and its candidate is a drop that consists of a proprietary antiviral in ocular decongestant and an antibacterial agent. Joining The Ophthalmic Project to discuss this new conjunctivitis drug is Josh Moriarty, CEO of Okogen. Josh, welcome to The Ophthalmic Project.
Josh Moriarty:
Thanks, Mark. Pleasure to be here today.
Mark Dlugoss:
Before we begin our discussion with an overview of Okogen. Okogen has been around almost 10 years now, and it was formed as a private biotech company based in Plano, Texas. Can you provide a history of Okogen, how the company was founded, its mission, its focus, and plans as an ophthalmic company?
Josh Moriarty:
Yeah, certainly. Okogen was founded back in 2015. Really to kind of understand that time period, looking back, I remember in 2014 there was, I don’t know if it was front page, but it was close to front page of the Wall Street Journal, and they did an article and the full page was the anatomy of the body. They outlined venture capital investment by body type or body part at that point in time. The top 2 investment areas were the eye and the ear, and that’s going way, way back. But interestingly enough, that sort of coincided with the time that Brent Saunders came into Allergan and brought forth his idea of sort of external innovation of looking toward smaller, more nimble venture backed companies that could honestly de-risk assets for the larger commercial organizations, the Allergans, the Alcons, Bauschs at the time. Okogen was one of honestly dozens of companies at that point in time that were looking at things and saying, “Hey, what are some of the unmet needs in the marketplace? What are areas that maybe there’ve been some failures?”
People look at as riskier areas to develop products. The founders, Brian and Eric at the time, they had found this drug ranpirnase, which was actually being studied in oncology. Believe it or not, some of the data from some of the phase 3 studies at the time found that a lot of these patients weren’t even getting things like a cold or a flu. Sort of a side effect piece of information that they found, and they looked at it and said, well, hey, maybe there’s some good potential here for viral conjunctivitis, which at the time, no treatments on the market. There had been probably about a half a dozen programs in the previous 10 years that had failed to show efficacy all the way through clinical trials. It was an area that they really wanted to explore, put together a deal to bring in the technology, founded the company, and it was off to the races from there. Originally, when the company was founded, it was really focused solely around viral conjunctivitis.
Mark Dlugoss:
Your plan’s going to stay that way as an ophthalmic company and be it focused on conjunctivitis. Correct?
Josh Moriarty:
Yes. That is the goal of this company. We’re not a company that was built to explore 10 different therapeutic areas within eye care. We’re solely focused on conjunctivitis, have broadened out a bit from just viral conjunctivitis to acute infectious conjunctivitis, so encompassing both viral and bacterial. That’s really where we see the market opportunity and the market need.
Mark Dlugoss:
Now, Josh, you joined Okogen in March of 2022 as Chief Executive Officer. Man, your background, you’ve been over 20-some years ophthalmic product development. You bring a lot of that to Okogen. But for viewers who may not be aware of you, can you provide some background about yourself and your career in the ophthalmic industry and what does your experience bring to the table for Okogen?
Josh Moriarty:
Obviously being in the eye care world for, it’ll be 20 years, believe it or not, in about a month and a half. I was in kindergarten when I started, which is the obvious thing. But no, I started, it was in 2005, and at the time, I started with a small clinical research company called Ora. There was about 20 of us at the time when I started, and now that organization is four or five, 600 a global organization. Honestly, a lot of that growth at Ora was from what I just talked about, is these smaller, more nimble companies that may not have the huge infrastructure of the larger organizations.
It was really an incredible time to be there and an incredible time to learn every single aspect of drug development and just a unique opportunity to see everything from early stage basic science and preclinical research all the way through preclinical to the clinical trials and post-market support, etc. It was really an invaluable opportunity. Honestly, even working with innovators, entrepreneurs, the amount of folks that I’ve worked with over the years that originally came to us with just one idea, and now some of them are leading a multinational global commercial organization. It’s been a great opportunity to learn over the years.
Mark Dlugoss:
Now, your management team and your board of directors and your scientific and medical team, they bring a lot of experience in corneal disease and infection. Can you discuss some of your team members and management and board of directors and scientific team?
Josh Moriarty:
Yeah, absolutely. I think first and foremost, which we just announced about a week and a half ago, David Hollander, who’s an ophthalmologist and been in industry for about the same amount of time that I have, was previously at Allergan and a number of other area ophthalmic companies. I’ve had the opportunity to work with David for about a dozen years now, and he’s really one of those people that brings together the medicine, the science, the commercial market knowledge, and he’s going to be a tremendous asset to us as we move forward. Some of our advisory board, amazing physicians, ophthalmologists, and to your point, external corneal disease guys, and they were really crucial I think when Brian and Eric were founding the company to bring that medical perspective, to bring the eye care practitioner knowledge into the fold.
One of the things that we’re actually looking at now too is as we look at this disease and we study it more, understand the market more, who’s prescribing these drugs, who’s evaluating the disease, and we’re starting to expand that group. You’ll see over in the coming months into folks that are working in urgent care to understand their perspective. When they see a patient with a red eye come in, what do they do? Pediatrics is going to be a huge area for us to bring in some folks as well.
Mark Dlugoss:
Now, before we get into the details of Okogen’s lead candidate for acute infectious conjunctivitis, let’s discuss the current market. It seems really, I didn’t realize there’s how big of a market this was, but I’ll let you give the details about this, how big the market is.
Josh Moriarty:
Yeah, it’s a multi-billion dollar market, and to your point, nobody truly understands how big that market is. I think one of the reasons is nobody wants to hear from other people that they have pink eye. It’s like, great, you have pink eye, or your kid has pink eye or there’s an outbreak at the daycare. But it really is a huge, huge market that currently it’s pretty underserved with antibiotic products at this point in time. One of the interesting facts is that about 95% of diagnosed cases, and I say diagnosed because we do know, and it’s a number that is unfortunately hard to get at, is there’s a lot of people that get pink eye. Maybe they just use some artificial tears at home. Maybe in today’s world they work from home, so there’s no chance of spreading it in the workplace or with kids.
There’s a large portion that goes undiagnosed, but 95% of cases that are diagnosed are diagnosed as just conjunctivitis. Without an etiology of the disease either being viral or bacterial or potentially allergic as well, if they’re just calling it conjunctivitis, but 85% of those, 95% of cases are prescribed an antibiotic just right off the bat. Even if you think about it with pediatricians, your child comes in, comes home from school, next morning they wake up and they’ve got pink eye. You make a call into the pediatrician’s office. Most of the time they don’t want that patient even coming into the office. A prescription is just called into the pharmacy. Again, no current treatments for viral, so it’s usually an antibiotic. When we look at that, we say, well, what’s the problem here? Well, if you go back and you think about things, it’s very hard to diagnose between viral and bacterial.
One of the common things is, well, is there a sore throat present as well? If the patient has a sore throat, then it must be viral. It’s probably not bacterial. The discharge can be different where viral is a little bit more watery, more tearing-like, and bacterial is sort of a pus-y sticky discharge. The big thing is, and when I talk with eye care professionals, they say, well, it’s pretty easy. It’s like, well, they sit the patient down, they look at them through the slit lamp. They’ve been trained in the eye what to look for and the different things. Most of the healthcare professionals that are diagnosing, they don’t have a slit lamp. They’ve had very minor training in terms of the eye and the function of the eye and the different diseases of the eye. It’s very difficult for them to diagnose between the 2 diseases.
Mark Dlugoss:
You mentioned that a lot of people go to their pediatricians when they have children involved and probably go to the primary care. What’s the percentage of eye care providers versus, say, pediatricians and primary care doctors that are seeing these kind of patients?
Josh Moriarty:
It’s about 25% is eye care professionals. A large portion, and even within that 25%, there’s a good portion of that, probably about a third, that represents a second visit. Maybe they’ve gone to a pediatrician, they’ve gone onto an antibiotic, nothing’s getting better. Then, they’re referred to an optometrist or an ophthalmologist for a second visit. But the majority are those primary care type settings. Believe it or not, especially in a post pandemic world, after we spent lots of time going to urgent care to get COVID tests and things like that, urgent care and telemedicine is the fastest growing segment for pink eye.
Mark Dlugoss:
Amazing. Let’s talk about Okogen’s lead candidate, which is OKG-0303. What’s the science behind drug candidate?
Josh Moriarty:
We had originally done a study that was actually halted called the Ruby Study in Australia. The study was halted due to the COVID-19 pandemic, but we did get some data out of that study. The data that we did get is we were able to see we were shutting down viral replication. That’s the way our proprietary antiviral ranpirnase works. It’s not like we put a drop in the eye and it kills the virus on contact. We’re shutting down the replication, which ends up being a shorter time course. We were able to see, and basically within a few days, these patients were getting better. Their viral load was shutting down and basically clearing out. One of the things that we didn’t see was on the symptom side of things, and namely for conjunctivitis, regulatory agencies want to look toward redness and discharge. We didn’t see great data there.
It was at that point in time, and this was about when I was joining the company that we started to look at things and said, well, how can we handle the redness in the discharge? We looked at potentially adding a decongestant to the product to handle the symptom side of things. Ultimately, you need to handle that symptom side because when a patient wakes up and they look in the mirror, or if it’s a child and they walk downstairs to see their parents in the morning, looking at a patient, you can’t tell if they’re doing better unless the things that they can actually see, there’s reduced discharge, there’s less redness in the eye. Those are things that can allow the patient or the caregivers to understand that they’re doing better. Unfortunately, there’s no visual way to understand viral or bacterial load on the eye. We have to handle the symptom side.
Then once we had that, we were looking at it and we took a deep dive into the market and the market research to understand how these patients were diagnosed, or honestly, in this case they’re not diagnosed properly. We listened to potential commercial partners. We listened to investors who didn’t truly understand how a viral drug would get prescribed instead of an antibiotic. We said, well, what if we also add an antibiotic in there? Of course, our first thing, and a lot of people said to us is, well, what about overuse of antibiotics? I’ll go back to my point earlier; 85% of these patients who are diagnosed, they’re receiving the antibiotic already. Also when you’re delivering topically to the eye and, Mark, you know with your history over the years, the systemic absorption of an eye drop into the rest of the body is very, very minimal.
Mark Dlugoss:
What stands out about the drug that makes it unusual or different from anything that’s out there right now?
Josh Moriarty:
Well, it would be the very first treatment to hit the market to be able to treat viral conjunctivitis, so obviously hitting that very huge unmet medical need in the market. When you look at this, we call this a 1-stop shop. When you have a patient or a child with pink eye, it’s one of those things where especially if it’s the viral side of acute infectious conjunctivitis, you just have to sit and wait. You have to quarantine, constant hand washing, etc.
There’s loss of time at school. For the parents, there’s loss of time at work. Being able to provide a drug to these patients is going to be a huge game-changer. Being able to treat patients with either form of the disease is really going to be a unique opportunity for the market. One of the things that we’re really looking at and hasn’t been truly studied quite a bit is from, at least anecdotally at this point, and I’ll have more later this year after we do our study this summer, anecdotally, there’s a lot of physicians out there, eye care professionals that believe there’s a lot of concurrency of both diseases occurring at the same time.
Mark Dlugoss:
You mentioned Okogen has 2 clinical trials. One was the Australia, which obviously discontinued, but the Ruby trial focused on which one of the components, I guess, -0303, isn’t it? It was like OKG-0303. Can you explain the correlation?
Josh Moriarty:
OKG-030 was a formulation of just our antiviral ranpirnase. At the time, again, the company was focused on just viral conjunctivitis. That formulation that was tested in that study was just a formulated version of ranpirnase for the eye.
Mark Dlugoss:
The second one obviously is the Emerald Study. Let’s discuss the parameters of that trial and what endpoints are you looking to achieve with it?
Josh Moriarty:
Yeah, this is a study that will be conducted actually in India this summer. One of the reasons that we’re looking at India is when they have their monsoon season in the summertime. You can even look back historically to previous viral and bacterial conjunctivitis programs, there’s a lot of work that’s done in India and Southeast Asia. One of the things is when they get their monsoon season and the heavy rains, the amount of cases just they’re through the roof. To the point that some of the larger eye hospitals in India, one ophthalmologist may see 20, 30 cases a day. In terms of enrollment of a clinical trial, it’s a unique opportunity and environment to be able to conduct the trial. Ultimately, there in that study, this will be the first clinical trial that has our combination product with the ranpirnase decongestant and the antibiotic.
We’re really going to focus on the viral conjunctivitis population, but also include those that may also have bacterial conjunctivitis concurrently. That’s a unique thing in a study that we haven’t seen done previously. We’re very interested to see, again, like we just talked about, is there certainly overlap of both of these diseases occurring at the same time? But even more so what we’re looking at is we want to see compared to our placebo group is are we shortening the time course to reducing viral and or bacterial load or both at the same time? Also from a symptom perspective, redness and discharge. Normal time course for conjunctivitis if left untreated is 10 to 20 days. If we can get that down, that’s going to represent a significant change in how these patients are treated, and honestly, when they can get back to school and work.
Mark Dlugoss:
That’s amazing. Getting it 4 days, that’s pretty good. When do you expect to present or have data on the Emerald Study?
Josh Moriarty:
It will be later this year. Like I mentioned, the timing of this study is to coincide with the monsoon season because just as quick as the rates of conjunctivitis rise, they also go down on the down slope, right? This isn’t something that we want to continue a trial and wait another year and keep it open. We plan to have data later this year.
Mark Dlugoss:
Now, what’s Okogen’s timeline for developing clinical trials in the states? Have you had pre-IND meetings with the FDA? What kind of feedback have you received, if you have had feedback, have you gotten from the FDA?
Josh Moriarty:
Yeah, so Okogen as a company has had a couple of pre-IND meetings where we’ve talked about everything from formulations and the requirements, obviously with a combination product, and FDA has guidances about how to develop those combination products. We have had those meetings and have pretty clear direction at this point in time. Ultimately, one of the goals of the study, the Emerald Study over in India as well, is we want to understand each contribution that our different actives are providing into this drug and understanding those differences. In terms of clinical trials, Mark, next year, like I said, I mean this is going to be a phase 2 study. From there, if the study is successful, we’re going to start going through our checklist to get everything done to file our IND, and hopefully, depending on either a potential partner or future fundraising, we’ll start the phase 3 trials next year, which the US would be a component, but certainly there would also be an international component as well to those.
Mark Dlugoss:
I assume you’re using the Emerald Study as part of that phase 3 trial.
Josh Moriarty:
This will be supportive toward the phase 3 and what the design of those phase three trials will look like in particular related to patient population and points.
Mark Dlugoss:
Now with the Emerald Study, Okogen is developing an AI-powered image-based evaluation tool aimed at improving patient care, not only for the development of OKG-0303, but addressing the gaps in managing conjunctivitis. Could you outline some of what’s going on with that tool and how that came about?
Josh Moriarty:
Yeah, Mark, timing is everything. Even in my years on the development side, prior to joining Okogen, I worked with a number of companies looking at AI-powered either evaluation as we’re saying or diagnostic tools at the time. Some of them have made it to market. Some of them are still in the process of collecting data and information to get the products to the point where they’re working. It really comes down to timing. Artificial intelligence as anybody who turns on the news or flips through anything on the internet, it’s where everything is headed. The data that we’ll be collecting in our study this summer ultimately is going to become a unique data set in order to train our AI algorithm. It’s one of those things where even 3 years ago, the technology, it wasn’t advanced enough, but now we’re at a technology with our minimal training set that we have right now, we’re in the 90% confidence interval.
That’s with a very, very minimal data set. What we’re looking at is as we collect the data, we’re going to have a pretty bulletproof training set in order to train this AI. If you read deeply into the AI stuff, and you can learn about different languages and different models and all this stuff, but the number 1 thing that it all comes back to is how are you training your AI and is that data accurate? We’re going to have some images. We’re going to be able to bring all of those things together so that potentially in the future, whether this is via telemedicine, whether this is a tool that a non-eyecare professional or an eye care professional could use in office, could be used a multitude of ways, and we’re looking at it. This is not something that we’re looking to replace and it’s an ultimate diagnosis tool. This is another evaluation tool that healthcare professionals can use and ultimately be able to look at things from their perspective and say, okay, here’s another piece of information that we have.
Mark Dlugoss:
You can use this beyond conjunctivitis. It could be anything else, right?
Josh Moriarty:
It certainly could. Whether that’s in the eye or other places, again, it goes back to that training data, and if you have that correct amount of data and the right data to train something; it’s no different ChatGPT. What do they use? They use every book and anything that’s ever been published on the internet, so they have all of that information that’s there. Training these algorithms is the way to make them accurate.
Mark Dlugoss:
Since Okogen is focusing on viral and bacterial conjunctivitis, are there any other pipeline opportunities that Okogen is exploring and that you might be able to share with our viewers?
Josh Moriarty:
All I’ll say at this point in time is that we’re open to looking at things, and we’re open to markets that are truly underserved. There’s a lot of areas of the eye and diseases of the eye that have a multitude of drugs, and we’re looking at things a little bit differently and we’re looking at underserved markets where there’s pretty significant opportunity.
Mark Dlugoss:
If viewers are interested in learning more about Okogen and your candidate for acute infectious conjunctivitis, how can they go about contacting you and Okogen?
Josh Moriarty:
You could go to our website, Okogen.com.
Mark Dlugoss:
Our discussion has covered a lot of information about Okogen and its planned to develop the drug to address acute infectious conjunctivitis. Are there any other points you would like to add regarding Okogen and its programs before we close?
Josh Moriarty:
I think our goals are to get this study done this summer and is to have data later this year and to start sharing that with folks. Ultimately, this company was not built to become a multinational conglomerate commercial organization. We are going to be looking for potential partners once we have our data in hand, and happy to discuss that with any of those folks.
Mark Dlugoss:
That’s great. Well, that concludes today’s Ophthalmic Project podcast. I want to thank Josh Moriarty for outlining Okogen’s new candidate for infectious conjunctivitis. I also want to thank you, the viewers, for watching, and I hope you’ll join us for the next edition of The Ophthalmic Project, powered by Ophthalmology 360. I hope to see you next time, and have a great day.
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