Core Viewpoint - Disc Medicine, Inc. is preparing to discuss feedback from the FDA regarding its investigational drug bitopertin for treating erythropoietic protoporphyria (EPP) in a conference call scheduled for January 21, 2025 [1]. Company Overview - Disc Medicine is a clinical-stage biopharmaceutical company focused on developing novel treatments for serious hematologic diseases, aiming to create first-in-class therapeutic candidates targeting heme biosynthesis and iron homeostasis [6]. Product Information - Bitopertin is an investigational, orally administered inhibitor of glycine transporter 1 (GlyT1), designed to modulate heme biosynthesis and support erythropoiesis [3]. - The drug is being developed as a potential treatment for various hematologic diseases, including EPP, and has undergone multiple clinical trials, including the Phase 2 BEACON trial and the Phase 2 AURORA trial [3][4]. Disease Context - Erythropoietic protoporphyria (EPP) is a rare and debilitating disease caused by mutations affecting heme biosynthesis, leading to severe reactions to sunlight and potential liver complications [5]. - Current treatment options are limited, with only one FDA-approved therapy available, highlighting the significant unmet medical need in this area [5].
Disc Medicine to Host Conference Call on Type C Meeting for Bitopertin in Erythropoietic Protoporphyria (EPP)