- NGM Biopharmaceuticals Inc NGM announced topline efficacy and safety results from its CATALINA Phase 2 trial of NGM621 for geographic atrophy (GA) secondary to age-related macular degeneration (AMD).
- Over 52 weeks of treatment, NGM621 administered every four weeks (Q4W) (n=108) and every eight weeks (Q8W) (n=104) demonstrated a GA lesion area reduction of 6.3% and 6.5%, respectively, compared to sham (n=106), which did not reach statistical significance in either arm.
- NGM621 demonstrated a favorable safety profile, with no evidence of increased choroidal neovascularization (CNV) conversions and numerically fewer cases of CNV in NGM621-treated patients compared to sham. In addition, there were no drug-related serious adverse events.
- "We continue to evaluate various pre-specified secondary endpoints and post-hoc analyses," said David Woodhouse, CEO.
- "We expect these additional findings, as well as the absence of treatment-related CNV conversion and the overall clean safety profile NGM621, showed in CATALINA, to provide important information regarding the treatment of patients with GA," Woodhouse added.
- Price Action: NGM shares are down 71% at $3.25 during the premarket session on the last check Monday.
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