NGM Biopharmaceuticals (NASDAQ:NGM) has initiated the Phase 2 CATALINA study, to evaluate the safety and efficacy of NGM621 intravitreal injections in geographic atrophy (GA), secondary to age-related macular degeneration.
The 240-subject study’s primary efficacy endpoint is change from baseline in the square root of GA lesion area at 48 weeks, as measured by fundus autofluorescence imaging, compared to sham control.
Safety endpoints will evaluate the incidence and severity of ocular and systemic adverse events.
Preclinical and Phase 1 study showed positive safety and tolerability data for NGM621. NGM recently presented preclinical findings at The Association for Research in Vision and Ophthalmology Annual Meeting.
NGM621 is a humanized IgG1 monoclonal antibody designed to inhibit complement C3, key component, which helps orchestrate the body’s response to infection and maintains tissue homeostasis.
No comments:
Post a Comment
Note: Only a member of this blog may post a comment.