Opthea (OPT: $0.85) is currently conducting two Phase III studies with its ophthalmic drug candidate, OPT-302, for the treatment of wet AMD. Those trials are seeking to recruit just under 2,000 people. With completion of recruitment approaching, that major milestone will trigger a countdown to the pending results a little over 12 months later, which should see considerable interest build in the stock.
Opthea started the study in the US almost two years ago in March 2021 with Europe and the Asia Pacific region opening in October of that year. At the time results were anticipated this year however that has been pushed out by a year, with results now due in 2024.
In the company's annual report, it indicated that recruitment should be completed in both studies by mid 2023. With a 12-month treatment period, top line results should then be available shortly after mid 2024. Optimised Phase III Studies
Opthea has developed a clever design that has been accepted by regulators. This includes one Phase III study assessing the benefits of OPT-302 with Eylea compared to Eylea alone, and the second Phase III trial in combination with Lucentis compared to Lucentis alone. This will potentially deliver the company with a label for use in combination with both leading drugs on the market, which have the majority of the US$8 billion annual market.
Opthea has also been able to gain agreement from US and European regulators to enrich its patient population. This means that the primary analysis will be in patients with two particular forms of wet AMD, minimally classic and occult, which represents between 65%-80% of the market according to the company. There was greater benefit seen in these patient subgroups in the Phase IIb trial, with a mean 5.7 letter benefit.
Across all lesions the benefit over the control was 3.4 letters, which was statistically significant. (The company has also excluded RAP lesions, which delivered a 4.4 letter benefit overall in the Phase II study.) Presumably if clear benefit is shown across all patients, then the company will be able to include all patient populations in its marketing label (excluding RAP lesions).
Non-Equity Funding Sourced
Last year Opthea sourced up to US$170 million from Carlyle and Abingworth in the largest investment from that group to date. The investment group stands to receive up to four times its original investment from product sales or royalties. Opthea has received US$85 million to date with up to US$85 million expected over the next 12 months according to Opthea CEO Megan Baldwin.
The pricing of OPT-302 is expected to be similar to existing products on the market. The first generics in this market are expected to be available in 2025.
Opthea also has secured fast track designation with the FDA, which means that its approval document for OPT-302 (a biologic) can be submitted in modules, with more frequent dialogue with the regulator possible.
Opthea is capitalised at $397 million with US$142 million in cash at the end of last year.
Bioshares recommendation: Speculative Buy Class A
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