Apellis Pharmaceuticals Inc (NASDAQ:APLS) recently 18 months’ worth of data collected through its Phase 1b APL2-103 study evaluating pegcetacoplan as a treatment for advanced geographic atrophy (GA).
The phase 1b APL2-103 study particularly focuses on using pegcetacoplan to treat GA that is related to low vision and age-related macular degeneration (AMD). GA affects roughly 5 million people globally and it is particularly dangerous because it may result in blindness. Even worse is that there is no approved cure for the disease. It thus represents a sizable untapped market.
The Phase 1b APL2-103 study evaluated 12 patients diagnosed with bilateral GA which means that both eyes were affected. The study was conducted to determine pegcetacoplan’s (15mg/0.1mL) safety profile. Patients in the study received a pegcetacoplan dose every month in one eye while the other eye remained untreated.
The findings from the Phase 1b study were consistent with the results that Apellis revealed during the 12th week of the study. The researchers observed a significant reduction in the growth of GE lesions in the eye treated with pegcetacoplan compared to the untreated eye. The recently released data reveals that the treated eye has an average of 52% fewer lesions than the untreated eye. This is significant because GA lesions tend to grow at the same rate in both eyes when a person is diagnosed with the disease.
The study maintains a strong safety profile
The phase 1b study findings also indicate that none of the patients experienced any inflammation. Only one of the study participants experienced exudation 12 months after the first dose.
“It is exciting to see data for the efficacy of intravitreal pegcetacoplan at 18 months among patients with GA,” stated Dr. Charles Wykoff, the head of research at Retina Consultants of Houston. He also said that the data collected from the phase 1 APL2-103 study reflects the results of the Phase 2 FILLY. The 52% lesion reduction and the good safety profile is a demonstration of pegetacoplan’s ability to deliver therapeutic relief in the right direction. Apellis believes that the findings are strong enough to support continued research into delivering a working therapy for GA patients.
