Apellis Unveils Mixed Results For Eye Disorder Drug, But Still Hopes To Pass FDA Finish Line

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Apellis Pharmaceuticals Inc's (NASDAQ:APLS) pegcetacoplan posted mixed results in two Phase 3 trials in 1,258 geographic atrophy (GA).
Despite the mixed showing, CEO Cedric Francois thinks the candidates' performance was strong enough to warrant an FDA nod.
The Company plans to file a marketing application to the FDA in 1H of FY22.
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In Oaks study, pegcetacoplan met its primary endpoint in both dosing groups, significantly reducing GA lesion growth by 22% in the monthly arm and 16% in the every-other-month group compared with sham injections after 12 months.
The drug failed to do the same in the Derby study, reducing lesions by 12% and 11%, respectively.
The drug didn't produce any significant safety concerns in both trials, although its use was associated with slightly higher exudation rates or emitted fluid.
In a prespecified analysis of the combined trials, pegcetacoplan was more effective in patients with extrafoveal lesions, decreasing GA lesion growth in that group by 26% in the monthly arm and 23% in the every-other-month group.
Apellis also said monthly doses of the drug in both studies cut lesion growth by 17% overall, and a once-every-other-month dose cut lesion growth by 14% compared with sham.
On the safety front, 6% of patients reported exudations in the monthly dose cohorts and 4.1% in the every-other-month cohorts.
There were two confirmed cases of infectious endophthalmitis and another suspected case among 6,331 injections administered during the studies.
Meanwhile, there were 13 cases of intraocular inflammation reported, and no retinal vasculitis or retinal vein occlusion was reported.
Price Action: APLS shares are down 31.7% at $38.00 during the premarket session on the last check Friday.

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Apellis Unveils Mixed Results For Eye Disorder Drug, But Still Hopes To Pass FDA Finish Line

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