Opthea (ASX:OPT) has announced it will discontinue clinical trials involving its sozinibercept in combination with other therapies for treating wet age-related macular degeneration (wet AMD).
The company recently announced that data from its Phase 3 COAST trial of sozinibercept in combination with Novartis' LUCENTIS (ranibizumab) showed the combination did not achieve the primary endpoint.
It has now announced it will discontinue the Phase 3 ShORe trial of sozinibercept in combination with Bayer's EYELA (ranibizumab) in patients with wet AMD. Opthea said the trial was discontinued after the topline data readout was accelerated in response to the COAST trial announcement.
It said, "The trial did not meet its primary endpoint of mean change in best corrected visual acuity (BCVA) from baseline to week 52. In wet AMD patients with minimally classic and occult lesions, participants receiving sozinibercept combination therapy with a dosing regimen of every four weeks or every eight weeks achieved a mean change in BCVA of 13.3 or 12.9 letters from baseline to week 52, respectively, versus 14.2 letters with ranibizumab monotherapy."
"In the overall population, participants receiving sozinibercept combination therapy with a dosing regimen of every four weeks or every eight weeks achieved a mean change in BCVA of 13.3 and 12.6 letters from baseline to week 52, respectively, versus 14.3 letters with ranibizumab monotherapy," said Opthea.
“We are disappointed that COAST and ShORe did not demonstrate the improvements in vision with sozinibercept combination therapy compared to standard of care that we had hoped for,” said Frederic Guerard, CEO of Opthea. “We are grateful to all patients, clinical investigators and their staff around the world who participated in the sozinibercept Phase 3 clinical program, and for their contributions in investigating new treatments for wet AMD.”
Opthea said it remains possible that under its Development Funding Agreement (DFA), it could become required to pay a "multiple of the amount funded by the DFA Investors that would have a material adverse impact on the solvency of the Company."
"Opthea estimates it will have unaudited cash and cash equivalents of US$100M at the end of March 2025," said the company. "In light of these matters, there remains material uncertainty as to Opthea's ability to continue as a going concern. As noted above, discussions with the DFA Investors are ongoing and Opthea cannot be certain as to the outcome of those discussions or when that outcome may become known."
