Apellis Pharmaceuticals (APLS +2.4%) is up on average volume on the heels of results from a Phase 2 clinical trial, FILLY, evaluating lead candidate APL-2 (pegcetacoplan) in patients with geographic atrophy (GA) secondary to age-related macular degeneration (AMD), a Fast Track-tagged indication. The data were just published in the journal Ophthalmology.
Treatment with APL-2 via intravitreal injection produced statistically significant reductions in the growth of GA lesion area compared to sham (placebo) at month 12, the primary endpoint. Specifically, at month 12, patients treated once/month showed a 29% reduction in the growth of GA lesion area compared to the pooled sham group (p=0.008) while patients who were treated every other month (EOM) experienced a 20% reduction, although this difference was not statistically significant (p=0.067).
On the safety front, the rate of exudation (fluid oozing from the treated eye) was 20.9% in the monthly group and 8.9% in the EOM group versus 1.2% in sham-treated eyes. The effect was effectively managed with standard-of-care treatment.
GA is an advanced form of AMD than can lead to irreversible vision loss.
Two Phase 3 studies, DERBY and OAKS, are in process.
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