Opthea (ASX:OPT) talks treatment of eye disease


by Carolyn Herbert

Opthea Limited (ASX:OPT) Managing Director Dr Megan Baldwin discusses the company’s lead drug candidate OPT-302 for the treatment of aberrant blood vessel growth and vascular leakage.

Opthea Limited (ASX:OPT) is a Melbourne based biotechnology company. We are developing novel therapies for the treatment of eye diseases. And the two eye diseases we are focused on are wet age-related macular degeneration and diabetic macular edema. And so these are two of the leading causes of blindness in both the elderly population, as well as in the diabetic working age population. And our treatment, which we call OPT-302 is an injection into the eye and when we use it, we hope to see improvements in vision. Which of course, is an improvement in the quality of life of the patient.

Now we think that that’s an opportunity for us in terms of the market opportunity for this drug, because the existing therapies that are approved for these diseases, only work in a proportion of patients. And there are a large number of patients that don’t respond optimally. So by using our drug together with other existing therapies, we hope to improve those outcomes for patients.

Our company, as I’ve said it’s based in Melbourne, we’re listed on the ASX. We currently have 200 million shares on issue, 48 million options on issue; the share price is around about 85 to 90 cents. So our market cap is around $175 to $180 million and we have really novel, very exciting, early stage clinical asset for the treatment of eye disease.

So OPT-302 is an injection into the eye and what that drug does is mop up the signals that cause vessels to grow, and cause vessels to leak. And these are two of the hallmarks of disease progression for wet age-related macular degeneration, or wet AMD as well as for diabetic macular edema, or DME. So our drug, by injecting into the eye, is hoping to normalise those processes that occur in those eye diseases. And therefore, hopes to correct vision and improve visual acuity, in those patients suffering from that highly debilitating form of wet AMD and DME.

So we’ve just reported our outcomes from our first-in-human clinical study, which is a phase 1/2A clinical trial. We reported those outcomes in April of this year and we saw some very interesting evidence of clinical activity of our molecule, which is very exciting. Because we saw early evidence that our molecule was able to improve vision in patients, when patients were treated with the drug on its own, as well as when it was administered together with some of the existing therapies, for wet AMD in this case. So we’re very excited about the outcomes and it’s just completed its first clinical trial.

So in terms of the other drugs on the market, they all target a molecule or a signal called VEGF-A. Our molecule is different in that it targets other members of that same family. So it targets VEGF-C and D. So it’s a novel and differentiated product. And when we use it together with the existing therapies, we show that we were able to show about a five-letter gain, when patients look at an eye chart. And that’s enough to be a clinically meaningful benefit for patients, in terms of the improvement in vision. So that’s very exciting.

So we raised $45 million in the recent financing, which completed in April 2017. We raised funds at 93 cents per share, which at the time of the fundraising, was 14 per cent premium to the last closed share price. So it was a very successful fund raising. We welcomed a number of institutional healthcare specialist investors, to our register and it was also strongly supported by our existing shareholders as well. The fund raising consisted of a $35 million placement to institutional investors, as well as a $10 million entitlement offer. And as I said, it was completed at 93 cents per share.

In terms of the funding, that $45 million obviously increases our balance sheet, but it fully funds us through 2020 and through an additional three clinical trials. A large phase 2B clinical study in wet AMD patients, as well as two additional phase 2A studies. Both in DME, diabetic macular edema, as well as in wet AMD patients. So we have multiple shots on goal now with our asset OPT-302.

In terms of 2017, one of the highlights is obviously this very successful fundraising, which has strengthened our balance sheet and set us up very well, to execute on our clinical development strategy. The reporting out of the very positive data that we got from our phase I/2A clinical study was really a highlight. Those results really exceeded our expectations and it’s really increased the profile of the company. Both here in the local ophthalmology community, but really globally in the United States as well as internationally as well. So they’re really the operational highlights, as well as the financial highlights as well.

Certainly we are on a very positive outlook for 2017 and lots of that is coming out of the very positive data that we reported, in our phase 1/2A clinical trial. We will continue to report out data from that phase 1/2A clinical study, both from the company side, but also our clinical investigators will be presenting our data at a number of international conferences, throughout the year. So there’s still more data to come.

In addition, we’re executing on our development plan to be able to initiate three clinical studies this year. A large phase 2B where they indeed study, as well as two phase 2A clinical trials across both wet AMD, as well as now moving into diabetic macular edema. So across multiple different eye diseases and there’s multiple shots on goal. And the reporting out of those clinical trials are really promised to be real meaningful clinical inflection points for the company.