Company Interview / The small cap itching closer to stopping dengue's spread

Dr David Foster of Island Pharmaceuticals (ASX:ILA) states that the firm has secured $3.5m in funding, boosting shares by 40%. The funds will advance a Phase 2 trial for its dengue antiviral, marking a crucial milestone for the company.

David reveals a unique Protect trial design using a challenge study to address dengue, which infects 400 million annually. It involves infecting healthy volunteers with an attenuated virus to explore both preventive and therapeutic possibilities.

David highlights the urgency due to dengue's spread. The trial's success is crucial with limited current therapies. By the first half of next year, they aim to have data and meet with the FDA to explore an endemic study, potentially moving to therapeutic field studies

Full unedited transcript below:

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Antiviral drug developer Island Pharmaceutical shares have been in focus today after it secured $3.5 million in new funding, shares rising by a very impressive 40%. The cash injection earmarked for advancing its clinical pipeline. To tell us more, Island Pharma CEO and MD doctor David Foster joins me now. Big spike in your shares. Tell us what it's all about, David.

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It's been a nice day. Yes, thank you very much. So we've had a nice spike in the shares today. And it's because we put out two announcements today. The first, uh, that we announced that we are initiating or we initiated yesterday, uh, dosing in our phase two clinical trial, we're developing small molecule antiviral molecule for dengue infections. And we completed a phase one study moving towards a phase two study. And yesterday we dosed the first cohort. Uh, so that's a major milestone for the company. As it turns out, we also were able to announce today that we closed on a $3.5 million financing that you that you mentioned, um, backed by some sophisticated biotech investors, were very excited about not only the investment but the investors. Uh, they're fantastic group. And we really couldn't be happier. It really sets us up to be able to drive through this phase two clinical trial. We're looking at another molecule that we may want to bring into the company, and it allows us to

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do further diligence on that molecule and even acquire it if we wanted to do that. And so we should be well funded for quite a while. Yeah. And it seems like you had some big investors, as you mentioned, including Angus Walker from Hong Kong and your island co-founder, doctor Bill Garner. Um, tell us a little bit more about the Key Trail Protect, though, and what you're planning on doing here.

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The Protect trial. Yeah. So the Protect trial, it's actually a really interesting trial design. So again, we're going after dengue infected individuals. We want to either try to prevent or treat the dengue infections. Dengue is a huge global problem. There's 400 million infections a year. And so we have a molecule that we think will work. There's a few ways you can do that. On the one hand, you can go to an endemic country and try to treat or prevent the infection in the field. With in an endemic country, those become very large, cumbersome clinical trials. Um, we are taking a different approach. We're doing what's called a challenge study. And by a challenge study, that means we're going to enroll healthy individuals, and then we infect them with an attenuated strain of the dengue virus. This is a virus that was created by the US Army. Um, it was actually initially created as a vaccine, but it was a little too hot, made people feel a little uncomfortable. And so so it couldn't be used as a vaccine. But the Army said, well, let's see what we can do. Can we learn something about a

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dengue infection? So the US Army has been running phase one studies in individuals looking at the dinghy infection. And now we have a cooperative research and development agreement in place with the Army. They're giving us that virus. And the data from that phase one study so that we can study it in our phase two protocol. The phase two protocol has two components. The first is a prophylactic. The second is a therapeutic. So on the first hand we're going to pre-treat individuals and then infect them with the with the attenuated virus and see if we can prevent the infection. In the second component of the study we're going to first infect them, let them develop a little bit of virus, let them begin to have some symptoms, and then start treating them and seeing if we can curtail those symptoms and prevent further arise. It's a great study. We get to do really small numbers of individuals, but the data is incredibly powerful. So we're really for the first time, I'm not aware of anybody else that has done a challenge study

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looking at both a prophylactic and a therapeutic possibility for their molecule. David, how much is time against you when we're looking at climate change spreading dengue across, um, places that haven't had it before? So that's that's a great question. I'm really glad you brought it up. When we started the company, we were shouting from the rooftops, the dinghy is coming, it's coming. It's getting worse and worse. And in fact, it's not just a tropical problem anymore. We're seeing dinghy move into places where it's not been seen before. It's certainly moving into the southern part of the United States. Um, there's a locally acquired dinghy outbreak in Los Angeles, California, right into Los Angeles. It's not tropical. And so the dinghy dinghy virus is there, as are the mosquitoes. So there are predictions that say by the year 2020 to 2050, just 26 years from now, the southeastern third of the United States will be endemic for dengue, as will the northern half of

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Australia, predicted to be endemic, it will be a hotspot. Currently, there's no effective therapies. There's no small molecule prophylactics. The vaccines that have been developed, um, are imperfect. Uh, probably putting it nicely. They have some challenges. So I think there's a huge opportunity for a small molecule that has activity against all four strains of the dengue virus. But you're right, we were working fast because there's nothing out there and the train is coming down the track. We need to be doing something right now. So what's the next step after what you mentioned with the trial phase?

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Right. So we'll be doing the this the the protect study. So we'll complete this phase two a study. We should have data by the end of this year. Uh, we'll start in January with the therapeutic part of that study. We're expecting data in the first half of next year. Um, when we finish that and we wrap up all the data, we'll meet with the FDA and have a discussion about what is the next trial look like. My prediction is that we will probably do an endemic study. We'll go to a country that has dengue that's endemic there and do the field study. I'm going to guess it may be a therapeutic, uh, therapeutic approach. And we'll go in knowing now what we know about this is the right dose. This is the time frame within which you can, uh, treat and have an effective response. So my anticipation is that we would have that direction.