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Apellis Pauses GA Trial due to Inflammation
Author: Joan McKenna
Apellis Pharmaceuticals has paused dosing in its Phase III clinical trial in geographic atrophy (GA) due to patients developing non-infectious inflammation from a single lot of APL-2, the company reported Oct. 17 in an SEC filing.
Four patients in the Phase III GA program and four in a Phase II study for wet age-related macular degeneration (wet AMD) were treated with the manufacturing lot, and all developed inflammation. Seven cases have resolved, and the other is expected to do so.
The company noted that APC-2 has an extensive prior safety history, with more than 1,500 intravitreal injections administered in the Phase II FILLY trial.
APL-2 is an inhibitor of complement factor C3 being developed as monotherapy for GA.
The Louisville company plans to resume dosing in the Phase III GA program by the end of 2018 if current non-human studies point to the single lot as the cause of the inflammation.
Apellis said dosing in the Phase II wet AMD trial is continuing with a different APL-2 lot.