Quantum BioPharma Receives Ethics Approval in Australia for FSD202 Chronic Pain Trial in Mast Cell Activation Syndrome Patients

Quantum BioPharma Ltd. announced that its Australian subsidiary, FSD Pharma Australia Pty Ltd., has received approval from an Australian human ethics review committee (HREC) to begin a new clinical trial. The study, titled “A Randomized, Double-Blind Placebo Controlled Parallel Group Decentralized Trial,” will evaluate the safety and efficacy of FSD202 in patients suffering from chronic widespread musculoskeletal nociplastic pain linked to idiopathic Mast Cell Activation Syndrome (MCAS). 

“We are excited to evaluate the efficacy and safety of FSD202 in a Phase 2 trial for the treatment of nociplastic pain associated with idiopathic MCAS. These patients often have a significantly reduced quality of life and are in desperate need of safe alternatives to the current standard of care,” said Dr. Andrzej Chruscinski, Vice-President, Scientific and Clinical Affairs at Quantum Biopharma.

The decentralized trial will enroll 60 patients diagnosed with MCAS, a complex condition marked by abnormal mast cell activity resulting in severe multisystem symptoms and persistent neurogenic pain. Participants will receive FSD202 or a placebo twice daily over 56 days, with the primary endpoint being a reduction in average daily pain intensity by Day 28. The trial also includes several secondary outcome measures to further assess the drug’s impact on symptom relief and quality of life.

Zeeshan Saeed, CEO of Quantum BioPharma, said, “We are delighted to receive HREC approval to proceed with our planned efficacy Phase 2 clinical trial of FSD202. Our clinical team has worked tirelessly to develop the clinical trial protocol and we are now looking forward to the next stages of clinical development for FSD202.”

FSD202 is an ultra-micronized palmitoylethanolamide (PEA) formulation with potential therapeutic applications across various inflammatory diseases, not limited to MCAS. This step by Quantum BioPharma was crucial, as chronic inflammation is the leading cause of death worldwide and is ranked the greatest threat by the WHO.