Quantum BioPharma Receives Ethics Committee Approval for Phase 2 Clinical Trial of FSD202 for Nociplastic Pain in Patients with Idiopathic Mast Cell Activation Syndrome

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[{"type":"text","content":"Quantum BioPharma Receives Ethics Committee Approval for Phase 2 Clinical Trial of FSD202 for Nociplastic Pain in Patients with Idiopathic Mast Cell Activation Syndrome\n\n\n\n TORONTO, May 28, 2025 (GLOBE NEWSWIRE) -- Quantum BioPharma Ltd. (NASDAQ: QNTM) (CSE: QNTM) (FRA: 0K91) (“\n \n Quantum BioPharma\n \n ” or the “\n \n Company\n \n ”), a biopharmaceutical company dedicated to building a portfolio of innovative assets and biotech solutions, today announces through its subsidiary, FSD Pharma Australia Pty Ltd., that it has received approval by the human ethics review committee (HREC) in Australia for its trial entitled “A Randomized, Double-Blind Placebo Controlled Parallel Group Decentralized Trial to Assess the Safety and Efficacy of FSD202 in Participants with Chronic Widespread Musculoskeletal Nociplastic Pain Associated with Idiopathic Mast Cell Activation Syndrome (Disorder).”\n \n\n The randomized, double-blind, placebo controlled parallel group decentralized trial will enroll 60 patients with idiopathic Mast Cell Activation Syndrome (“\n \n MCAS\n \n ”). Per the protocol, patients will receive FSD202 or placebo twice daily for 56 consecutive days. The primary outcome to be measured will be the decrease from baseline to Day 28 in the average daily pain intensity. The trial will also evaluate many secondary outcomes. MCAS refers to a group of disorders characterized by multisystem symptoms resulting from the accumulation of altered mast cells and/or abnormal mast cell mediator release, causing repeated anaphylactic symptoms/episodes and trapping a patient in a cycle of neurogenic pain and inflammation. Chronic widespread musculoskeletal nociplastic pain, a type of chronic pain characterized by altered pain perception that is not directly due to tissue injury, is associated with MCAS. The cause of MCAS is unknown and there currently is no cure.\n \n\n FSD202, a drug product containing ultra-micronized palmitoylethanolamide (PEA), has the potential to address a wide range of inflammatory diseases in addition to MCAS. This is especially important as chronic inflammatory diseases are the most significant cause of death globally and the World Health Organization ranks chronic disease as the greatest threat to human health.\n \n 1\n \n\n\n “We are excited to eva...

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