Apellis resumes phase 3 trial for patients with geographic atrophy

Apellis Pharmaceuticals has resumed dosing in two phase 3 trials of intravitreal APL-2, its geographic atrophy treatment, the company announced.

The DERBY and OAKS trials were paused in October 2018 after cases of noninfectious inflammation were observed in patients treated with a single lot of the APL-2 intravitreal investigational material, according to a press release.

The inflammation resolved in all affected patients, and Apellis believes an impurity in the active pharmaceutical ingredient was introduced during the scale-up of the manufacturing process, the release said. The manufacturing process has been modified to eliminate this impurity.

“Patient safety is our first priority, and we feel that we can now reinitiate our phase 3 program for patients with geographic atrophy with confidence following an in-depth investigation and modifications to the manufacturing process,” Cedric Francois, CEO and co-founder of Apellis, said in the release. “We remain on track for full enrollment by the end of the first quarter of 2020, as originally guided.”

Product from the modified manufacturing process has been used to treat 10 patients in the company’s ongoing phase 1b trial, and there has been no inflammation observed in those treated with this lot, the release said.

All data from the phase 1b trial were reviewed by an independent safety monitoring committee, which agreed to the phase 3 trial resuming with the drug produced in the modified manufacturing process.