Akari receives positive Pre-IND feedback from FDA for PAS-nomacopan

Akari Therapeutics announced that the company has received positive and constructive Pre-IND, PIND, feedback from the FDA on July 29, 2024, which provides additional clarity on Akari’s final Investigational New Drug Application- enabling preclinical plans, drug manufacturing and Phase 1 clinical strategy for long-acting PAS-nomacopan for intravitreal treatment of geographic atrophy. The regulatory feedback from the FDA and production of GMP material enables a clear path forward to submitting an IND, with the IND expected to be submitted in 2025.