Opthea Discontinues Wet AMD Trials After Another Failed Phase 3 Trial
Just a week after Opthea announced that its combination drug candidate—2 mg sozinibercept combined with 2 mg aflibercept—did not meet its primary endpoint in the COAST phase 3 trial, the company announced similar results with its phase 3 ShORe (Study of OPT-302 in combination with Ranibizumab) trial.
Following the results of the COAST trial, Opthea determined that the most appropriate course of action for wet AMD patients, shareholders, and other stakeholders was to accelerate the ShORe trial topline data readout, including in consultation with its Development Funding Agreement investors (DFA Investors).
The global ShORe phase 3 trial evaluated the efficacy and safety of intravitreally administered 2 mg sozinibercept every 4 or 8 weeks in combination with 0.5 mg ranibizumab every 4 weeks, as per label, versus 0.5 mg ranibizumab monotherapy. 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 4 weeks (n=301) or every 8 weeks (n=301) 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 (n=299, P-values of 0.35 and 0.19 respectively). In the overall population, participants receiving sozinibercept combination therapy with a dosing regimen of every 4 weeks (n=328) or every 8 weeks (n=326) 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 (n=331 P-values of 0.32 and 0.09 respectively).
Sozinibercept combination therapy was well tolerated.
Following the negative results of the COAST and ShORe trials, Opthea and the DFA Investors agreed to discontinue the development of sozinibercept in wet AMD with immediate effect.
“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,” Frederic Guerard, PharmD, Chief Executive Officer of Opthea, said in a company news release. “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.”
“As previously disclosed, the company has certain obligations under the DFA. In light of the Phase 3 clinical trial results, the company and the DFA Investors will continue to discuss this matter in good faith, and we will provide updates on this matter in the future,” Dr. Guerard said.
Opthea said it continues active discussions with the DFA Investors, pursuant to and as required under the DFA, to explore possible options to deliver the best outcome for the company and its shareholders.