Apellis Pharma down 17% on hiccup in late-stage study of APL-2

• Thinly traded Apellis Pharmaceuticals (APLS -16.9%) is down on almost double normal volume, albeit on turnover of only 434K shares, in reaction to its disclosure that it has paused dosing in its Phase 3 clinical trial, OAKS, evaluating APL-2 in patients with geographic atrophy due to instances of non-infectious inflammation in patients receiving a single lot of product.
• A total of eight participants developed inflammation, four in the Phase 3 program and four in the Phase 2 wet AMD study. Seven of the eight completely resolved and the other is expected to resolve.
• The company has started a series of non-human studies to confirm that the problem is confined to the single lot, expected to be completed by late November. Phase 3 dosing will resume by year-end if the isolation of the problem is verified.
• Dosing will continue in the Phase 2 study with a different lot.
• Previously: Dosing underway in Apellis Pharma's late-stage program of APL-2 in geographic atrophy (Sept. 12)