Opthea makes ophthalmology the focus


by Anna Napoli

Transcription of Finance News Network Interview with Opthea Limited (ASX:OPT) CEO and Managing Director, Dr Megan Baldwin
Carolyn Herbert: Opthea Limited (ASX:OPT) is a biologics drug developer focusing on ophthalmic disease therapies. I’m Carolyn Herbert and joining me at the CEO Sessions in Sydney is the company’s CEO and Managing Director, Dr Megan Baldwin. Megan, welcome to FNN.
Dr Megan Baldwin: Thanks for having me.
Carolyn Herbert: Could you start by giving us an introduction to Opthea?
Dr Megan Baldwin: Opthea trades on the ASX under the symbol OPT and we are a biologics drug development company, developing therapies for the treatment of eye disease. Most notably our lead candidate which is OPT-302, which is in development for the treatment of wet age-related macular degeneration, or wet AMD. Wet AMD is the leading cause of blindness in the western world; it’s a highly prevalent disease. And what our drug does is actually block blood vessel growth, and block vascular leakage. And these are two of the key hallmarks of the disease process.
So what we’re hoping to achieve with our drug is to address the unmet medical need that exists for patients that have wet AMD. So we want to prolong responses to the existing therapies. We want to improve vision in more patients and by a greater extent. Currently there are only two drugs on the market and they work sub-optimally in the patient. So we want to improve upon the outcomes for patients that suffer from this debilitating eye disease.
Carolyn Herbert: The company has recently undergone a name change from Circadian Technologies to Opthea. What was behind the change in name?
Dr Megan Baldwin: The name Opthea actually replaces the previous name of Circadian Technologies. And it realigns the corporate identity of the company with our product development strategy, to focus on eye disease therapies. It also is a name that our international and US investors particularly, are familiar with. And it’s basically a branding to reflect that we’re interested and are developing drugs, for eye diseases.
Carolyn Herbert: Can you tell us a bit more about your lead drug, its efficacy and where you’re at in the approvals process with it?
Dr Megan Baldwin: OPT-302 is a drug that blocks signals that are involved in blood vessel development. And we’ve shown in animal models of wet AMD, that when we inject it into the eyes of mice that have that disease, that it can very potently act on its own to suppress vessel development, and suppress vascular leakage. So it reduces the size of the wet AMD lesions to a comparable extent, to the multi billion-dollar drug that’s on the market, Eylea.
When we use the two drugs together, so when we combine our drug with that marketed agent, we see a further additive benefit in reducing wet AMD lesion size. We’re very encouraged by that, that it may have potential efficacy in humans to reduce the burden of the disease.  Right now we have a Phase I/IIa clinical trial that’s ongoing. We’re doing that in the United States at clinical trial sites, under the US Regulatory System. We expect the first data from that trial in wet AMD patients, to report out at the end of March this year. But we’ll also have further data updates from that clinical trial, coming out during 2016 as well.
Carolyn Herbert: Taking a look at your financials now, you’ve just released your results for the half-year ended 31 December 2015. What were the highlights?
Dr Megan Baldwin: At the end of 31st December 2015, we had $17.8 million in the bank. We also had about $900,000 worth of listed investments. And we had received an R&D tax credit on our R&D activities of $3 million. Importantly though, we have sufficient cash reserves in our bank to be able to fund, fully fund our wet AMD trial program. So that covers our Phase I/IIa ongoing study, as well as a larger Phase IIb clinical trial, that we have slated to be run in 2017 and 2018. So we have sufficient cash in bank to run our wet AMD programs until early 2018.
Carolyn Herbert: Finally Megan. What’s your outlook for the remainder of FY2016, and what are you hoping to achieve over the next 12 months?
Dr Megan Baldwin: Well 2016 is going to be a very exciting year for Opthea. We expect the report out of our data from our first-in-man clinical trial with OPT-302, and that’s the wet AMD clinical trial. As I’ve said, in late March we expect to have the first data start to come through, that’ll predominantly be safety data. But we’ll also be reporting throughout the year, on some of the clinical activity measures that come out of that clinical trial as well.
Towards the end of 2016, we expect to be reporting on the outcomes of our Phase IIa component of that study, which is an additional 30 patients that will have been treated with our drug, either as a single agent or in combination with the existing standard of care.
Carolyn Herbert: Dr Megan Baldwin, thanks for the update on Opthea.
Dr Megan Baldwin: Thank you very much.