Opthea Limited (ASX:OPT) Managing Director and CEO Dr Megan Baldwin talks about advances with the company's lead drug candidate OPT-302 in the treatment of wet age-related macular degeneration and diabetic macular edema.
Jessica Amir: Hello, I'm Jessica Amir for the Finance News Network. Joining me from Opthea is Managing Director and CEO, Dr. Megan Baldwin. Megan, thanks for coming. Welcome.
Dr Megan Baldwin: Thanks Jess.
Jessica Amir: For new investors, just give us a quick introduction to the company.
Dr Megan Baldwin: We are focused on developing novel therapies for the treatment of eye disease. We have a lead drug candidate in development, which we call OPT-302 and we're developing it for the treatment of two eye diseases. The first one being wet AMD or wet age-related macular degeneration, which is the leading cause of blindness in people aged over the age of 55. And the second indication is diabetic macular edema or DME, which is the leading cause of blindness in people with diabetes.
Dr Megan Baldwin: We currently have two clinical trials that are ongoing. A large phase 2B clinical study in wet AMD patients and a phase 1B/2A clinical trial in diabetic macular edema patients. Importantly, both of those diseases have an unmet medical need. There's only two approved therapies, so a limited therapeutic option for those patients, and we are developing one of the very promising new drugs that may actually improve vision in those patients that suffer from that debilitating eye disease.
Jessica Amir: Now to a little more on wet AMD. Just tell us about the disease.
Dr Megan Baldwin: So wet AMD or wet age-related macular degeneration is a disease of the aging process that affects the back of the eye. And what happens in that disease process is there's too many vessels that grow at the back of the eye, and as they grow, they're highly leaky. So there's fluid, there's vessels, and that can trigger inflammation, fibrosis, and scarring. And if it's left untreated, it leads to a chronic and often a very rapid decline in vision, which is generally in the centre of the vision field, and this is the region of the eye that's required for highly detailed focused vision.
Jessica Amir: Now tell us about the trial.
Dr Megan Baldwin: We're conducting it in ten countries around the world. Eight countries in Europe, the US, as well as Israel. It will enrol 351 patients and importantly, it's a randomised controlled clinical study. So we're testing OPT-302 in addition with the standard of care therapy for wet AMD which is referred to as Lucentis. And we're going to compare the vision in those patients to those patients that received Lucentis on its own.
Dr Megan Baldwin: So what we're really looking for is whether we can see an additive benefit of adding OPT-302 to the existing standard of care. And if we can demonstrate that in a Phase 2B clinical trial that is robustly powered as we have designed it, that's going to be a major clinical event for the company and a real indicator that we have a very promising drug indeed.
Jessica Amir: And what are the outcomes of the trial, and when can we expect data?
Dr Megan Baldwin: We're dosing patients for six months and what we're looking for there, as a primary read out, is the change in vision in those patients that received the combination OPT-302 therapy compared to the standard of care therapy alone. But in addition to measuring vision improvements, what we are also looking at is the anatomical parameters of the eye. So how thick is the retina? How much fluid can we resolve at the back of the eye? And all of those secondary outcomes are also very important, that may also signal the type of activity that our drug has to treat the debilitating eye disease of wet AMD. We expect the primary data outcome for the Phase 2B study to be reported early in 2020.
Jessica Amir: Now can you tell us about your diabetic macular edema program?
Dr Megan Baldwin: So diabetic macular edema is a disease that also affects the back of the eye. It is the leading cause of blindness in the diabetic population. So you can imagine how many people, millions of people, suffer from this form of blindness that's associated with diabetes. And what happens in that disease is that elevated glucose levels actually trigger vessels to grow and become highly leaky so there's a swelling at the back of the eye that's characterised by fluid. And what our drug does, when we inject it into the eyes of patients is blocks signals that are involved in making those vessels leak. And so we hope to block that leakage process and actually resolve fluid and therefore have our drug improve vision in patients that suffer from diabetic macular edema.
Dr Megan Baldwin: We have an ongoing study in DME right now. It is a Phase 1B/2A clinical trial. We hope to enrol 117 patients and we're recruiting patients from the United States as well as Australia. And the primary outcome of that clinical study is to look for the response rate in patients. So we're looking for those patients that receive the combination therapy and actually respond over and above what we would expect with Eylea on its own, which is a VEGF-A inhibitor.
Jessica Amir: A question about financials. Drug development typically requires deep pockets, so what are your funding requirements?
Dr Megan Baldwin: So, as I've said, we've got two clinical trials ongoing right now and we are fully funded through the outcomes of those studies. So we are fully funded through 2020 and the readout of the Phase 2B wet AMD and the Phase 1B/2A study in diabetic macular edema. At the end of April, we finished with approximately $37 million Australian dollars, cash in bank. And together with the R&D tax rebate, as I've said, we have enough cash in order to execute upon the clinical studies and read out the data from those studies.
Jessica Amir: And lastly, Megan, why should investors consider adding Opthea to their portfolio?
Dr Megan Baldwin: We have one of the most exciting and promising drug development programs in development right now. We have a quality data set that we’ve generated with our first in human clinical study that we reported in April 2017. That was a very good-sized Phase 1/2A clinical trial of 51 patients, and we generated real quality data, demonstrating biological activity of our molecule. We also demonstrated very importantly, that the drug is safe when injected into the eye. So we have been able to execute upon that positive data. We've raised $45 million cash in 2017, and it's really been backed by a large number of institutional health care investors from around the world. And many of those investors have done deep due diligence on our molecule. So they're aware of the potential of the molecule, they're aware of the market, and the commercial potential for a drug if we can demonstrate additional clinical benefit or vision improvement in patients when they receive OPT-302.
Jessica Amir: Well Dr. Megan Baldwin, thank you so much for the update.
Dr Megan Baldwin: Thank you very much.