Disc Medicine announces feedback from Type C meeting with FDA

Disc Medicine (IRON) announced positive feedback from its Type C meeting with the U.S. Food and Drug Administration, FDA, to discuss the APOLLO post-marketing confirmatory trial for bitopertin in EPP. The meeting resulted in alignment on the design of the APOLLO post-marketing confirmatory trial. Key features include: Co-primary endpoints of average monthly total time in sunlight without pain between 10:00 and 18:00 during the last month of the 6-month treatment period and percent change from baseline in whole blood metal-free PPIX after 6 months of treatment; Other measures of efficacy such as occurrence of phototoxic reactions, cumulative total pain-free time in sunlight, patient global impression of change, and time to prodrome; Selection of 60 mg dose of bitopertin and 6-month treatment duration; Inclusion of patients aged 12+ with EPP including X-linked protoporphyria; and Double-blind, placebo-controlled study with ~150 patients randomized 1:1.