Iveric bio Announces First Patient Dosed in Second Zimura Phase 3 Trial for Treatment of GA
Iveric bio announced the first patient has been dosed in GATHER2, also known as ISEE2008, the second phase 3 clinical trial for Zimura (avacincaptad pegol), a novel complement C5 inhibitor, in development for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). The company announced previously that Zimura met its prespecified primary efficacy endpoint and reached statistical significance in GATHER1, also known as OPH2003, the first phase 3 clinical trial for Zimura for the treatment of GA secondary to AMD. There are no FDA or European Medicines Agency approved treatments available for patients with GA secondary to AMD.
“The absence of treatment options for geographic atrophy represents an area of urgent unmet medical need and a major public health concern for the expanding aging population,” Glenn P. Sblendorio, Chief Executive Officer and President of Iveric bio, said in the news release. “The initiation of enrollment in GATHER2, brings us another step closer to potentially delivering a clinically meaningful therapy to patients with GA. The GATHER2 clinical trial, if positive, marks the second phase 3 clinical trial needed to seek regulatory approval for Zimura.”
“We believe GATHER1 is currently the only phase 3 clinical trial showing early suppression of GA growth which continued for 18 months with continuous treatment,” Kourous A. Rezaei, M.D., Chief Medical Officer of Iveric bio, said in the news release. “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. We believe that these robust data increase comfort and confidence in our investigators to expedite recruitment and retain patients in our GATHER2 clinical trial.”
In the GATHER2 clinical trial, approximately 400 patients will be randomized to receive either monthly administration of Zimura 2 mg or sham during the first 12 months of the trial, at which time the primary efficacy analysis of the mean rate of change of GA growth at 12 months will be performed. If the 12 month results are positive, the company plans to file an application with the FDA and the European Medicines Agency for marketing approval of Zimura for GA following receipt of that data. At month 12, the company plans to re-randomize patients in the Zimura 2 mg arm to receive either monthly or every other month administration of Zimura 2 mg. The final evaluation will take place at month 24.