Second phase 3 trial of Zimura underway
The first patient has been dosed in a second phase 3 clinical trial of Zimura for the treatment of geographic atrophy secondary to age-related macular degeneration, according to an Iveric bio press release.
Zimura (avacincaptad pegol), a novel complement C5 inhibitor, reached its primary efficacy endpoint in GATHER1, the first phase 3 trial.
In GATHER2, about 400 patients will be randomly assigned to receive monthly administration of either Zimura 2 mg or sham for 12 months. A primary efficacy analysis of the mean rate of change of geographic atrophy growth will occur at 12 months, and if the findings are positive, Iveric bio expects to file an application for marketing approval with the FDA and the European Medicines Agency.
At 12 months, patients will be reassigned to receive Zimura 2 mg monthly or every other month. The final analysis will take place at 24 months.
“We have experienced impressive enthusiasm by our investigators to initiate the second phase 3 trial, GATHER2, based on the robustness of efficacy, the strength of the statistical evidence and the favorable safety profile of Zimura in the GATHER1 phase 3 trial,” Kourous A. Rezaei, MD, chief medical officer of Iveric bio, said in the release. “We believe that these robust data increase comfort and confidence in our investigators to expedite recruitment and retain patients in our GATHER2 clinical trial.”