Business
Disc Medicine Initiates AURORA, a Phase 2 Clinical Study of Bitopertin in Adults with Erythropoietic Protoporphyria (EPP)
AURORA study designed to evaluate bitopertin as a potential disease-modifying treatment for adults with EPP in the United StatesAURORA study designed to
About this update from Disc Medicine, Inc.
[{"type":"text","content":"AURORA study designed to evaluate bitopertin as a potential disease-modifying treatment for adults with EPP in the United StatesAURORA study designed to assess changes in protoporphyrin IX levels, safety, tolerability, photosensitivity and other measures in a double-blind, placebo-controlled setting; top-line data expected in 2023WATERTOWN, Mass., Oct. 31, 2022 /PRNewswire/ -- Disc Medicine, a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of novel treatments for patients suffering from serious hematologic diseases, announced today the initiation of AURORA, a Phase 2 clinical study of bitopertin in adults with EPP. Bitopertin is an oral, selective inhibitor of glycine transporter 1 (GlyT1) designed to modulate heme biosynthesis, and has been shown in preclinical studies to reduce accumulation of protoporphyrin IX (PPIX), the toxic metabolite that causes disease pathology in EPP patients. Bitopertin is also currently being studied in BEACON, an open-label Phase 2 clinical study in patients with EPP and X-linked protoporphyria (XLP), which was announced in August 2022 and is being conducted in Australia.\n\n \n \n \n \n \n \n\n \n\"We are delighted to initiate AURORA, the first US-based study of bitopertin in patients with EPP. We are conducting the AURORA study to enable us to evaluate the effects of bitopertin on PPIX levels, photosensitivity, pain and other key measures in a rigorous, blinded trial,\" said John Quisel, JD, PhD, Chief Executive Officer at Disc Medicine. \"We have designed AURORA and BEACON to provide us with a robust assessment of bitopertin's potential as a disease-modifying therapy for EPP.\"\nThe AURORA Phase 2 study is a randomized, double-blind, placebo-controlled, parallel dosing clinical trial designed to evaluate the safety, tolerability, and efficacy of bitopertin in adults with EPP. It is expected to enroll approximately 75 patients at sites throughout the United States. Patients will receive orally-administered bitopertin for 120 days at doses of either 20 mg once-daily or 60 mg once-daily. Upon completion of the 120-day treatment period, patients may roll over to the open-label extension portion of the trial. The study is designed to measure changes in levels of metal-free PPIX, as well as measures of photosensitivity, daylight tolerance, pain, sa...