Roche Kicks Off Phase 3 Trial For Eye Disease Drug

Roche has started Phase 3 trials for its investigational drug lampalizumab as treatment for geographic atrophy, an advanced form of age-related macular degeneration (AMD).

Lampalizumab is an antigen-binding fragment (Fab) of a humanized, monoclonal antibody that works against complement factor D. Complement factor D is an enzyme that plays a role in the activation of the alternative complement pathway (ACP), which functions as a component of the immune system. ACP hyperactivity has been linked in the development of AMD, including geographic atrophy. The drug is being studied to ascertain its effect on geographic atrophy progression in relation to advanced AMD.

The company’s Phase 3 program for lampalizumab will investigate its safety and efficacy as well as its ability to slow GA progression. Mean change in GA lesion area of the selected study eye from baseline will also be measured. The two Phase 3 studies named Chroma (GX29176) and Spectri (GX29185) will also examine whether patients with a certain genetic biomarker, specifically a mutation in complement factor I, may benefit more from the drug. An estimated 936 patients will be enrolled in each study, divided into biomarker-positive and biomarker–negative populations.

The company decided to proceed to Phase 3 studies following positive results from the Phase 2 MAHALO study. MAHALO results showed a 20 percent reduction in GA lesion progression for patients treated with lampalizumab compared to sham. In addition, data from the group of biomarker positive patients showed a 44 percent reduction in disease progression rate at 18 months.

Sandra Horning, Head of Global Product Development and CMO at Roche, said, “Lampalizumab has the potential to represent a significant breakthrough for this disease and could provide real hope for GA patients. 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.”

This month, Roche also announced that it will present data from its oncology programs at the upcoming European Society for Medical Oncology (ESMO) 2014 Congress to be held later this month in Madrid, Spain.