A Study of NGM621 in Participants With Geographic Atrophy

Phase 2 Completed 320 enrolled NGM Biopharmaceuticals, Inc

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a multi-center evaluation of NGM621 in a randomized, double-masked, sham-controlled study in participants with Geographic Atrophy secondary to Age-related Macular Degeneration.

Timeline

Start: 2020-07-22
Primary completion: 2022-08-16
Completion: 2022-08-16

Outcome

Missed primary endpoint

registry analysis (superiority test); NGM621 Q4W vs Sham Q4W+Q8W; p = 0.4345; Mean Difference (Final Values) -0.150 (95% CI -0.528 to 0.227) NCT04465955 ↗

registry analysis (superiority test); NGM621 Q8W vs Sham Q4W+Q8W; p = 0.4217; Mean Difference (Final Values) -0.155 (95% CI -0.536 to 0.225) NCT04465955 ↗

release “While the CATALINA trial did not meet its primary endpoint” ngmbio.com ↗

release “the CATALINA Phase 2 trial of NGM621 in patients with geographic atrophy secondary to age-related macular degeneration did not meet primary endpoint” ngmbio.com ↗

Publications

Tzoumas N, Riding G, Williams MA, Steel DH. Complement inhibitors for age-related macular degeneration. Cochrane Database Syst Rev. 2023 Jun 14;6(6):CD009300. doi: 10.1002/14651858.CD009300.pub3.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	NGM621	Unknown	—	Intravitreal