Lampalizumab, the first potential treatment for geographic atrophy(GA), has entered phase 3 trials, according to Roche. The studies will also further explore if people with a specific genetic biomarker, a mutation in complement factor I, may benefit more from lampalizumab treatment.
“Lampalizumab has the potential to represent a significant breakthrough for this disease and could provide real hope for GA patients,” said Sandra Horning, MD, head of global product development and chief medical officer at Roche. “It is the first complement targeted therapy for GA to enter phase 3, and the only ophthalmic drug in clinical development that specifically targets complement factor D.”
Lampalizumab is an antigen-binding fragment of a humanized, monoclonal antibody directed against complement factor D, a rate-limiting enzyme involved in the activation of the alternative complement pathway.
The MAHALO phase II study showed a 20 percent reduction in GA lesion progression in patients treated monthly with lampalizumab as compared with sham at month 18. Additionally, data from GA patients receiving monthly lampalizumab and positive for the complement factor I biomarker, demonstrated a 44 percent decrease in the rate of disease progression at 18 months.
The phase 3 trials, called Chroma (GX29176) and Spectri (GX29185), are identically-designed, double-masked, randomized studies comparing a 10 mg intravitreal injection of lampalizumab administered every four or six weeks to sham injections. Approximately 936 patients will be enrolled in each study. The studies will recruit patients from approximately 300 physician-investigator sites in 24 countries worldwide. Key inclusion criteria are similar to that of the phase 2 MAHALO study and include the presence of GA in both eyes with no history of wet AMD.
The primary objective of the studies is to demonstrate a reduction in the rate of GA disease progression at 48 weeks, with secondary objectives focusing on the impact of lampalizumab on visual function.