NGM Bio’s NGM621 Receives the US FDA’s Fast Track Designation for the Treatment of Geographic Atrophy Secondary to Age-Related Macular Degeneration
Shots:
- The US FDA has granted FTD for NGM621 to treat patients with GA secondary to AMD. NGM621 (q4w or q8w, IVT inj.) is currently being evaluated in an ongoing P-II (CATALINA) study in a ratio (2:1:2:1) in 320 patients & the results are expected in Q4’22
- The primary efficacy EPs of the P-II (CATALINA) study is the rate of change in the GA lesion area as measured by FAF imaging @52wks. while the primary safety EPs will assess the incidence & severity of ocular & systemic AEs from treatment with NGM621 over sham control
- In the P-I study, the therapy showed single & multiple IVT inj. were reported to be safe and well-tolerated. NGM621 is a mAb product candidate engineered to potently inhibit complement C3
Ref: Globe Newswire | Image: NGM Bio
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