iNGEN? CRO Partners with Quantum BioPharma to Launch Pioneering Australian Clinical Trial for Chronic Nociplastic Pain in MCAS Patients

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[{"type":"text","content":"iNGENū CRO Partners with Quantum BioPharma to Launch Pioneering Australian Clinical Trial for Chronic Nociplastic Pain in MCAS PatientsStudy Aims to Expedite Potentially Transformative Therapies By Assessing Safety and Efficacy of FSD202\n\n\n\n Melbourne, Australia, June 02, 2025 (GLOBE NEWSWIRE) --\n \n iNGENū CRO\n \n , a leading full-service Contract Research Organization (CRO) in the Asia-Pacific region, is proud to announce its operational leadership role in a Phase 2 clinical trial launched in partnership with Quantum BioPharma Ltd. (NASDAQ: QNTM) (CSE: QNTM) (FRA: 0K91), a biopharmaceutical company dedicated to building a portfolio of innovative assets and biotech solutions.\n \n\n The study targets chronic widespread nociplastic pain associated with idiopathic Mast Cell Activation Syndrome/Disorder (MCAS/MCAD)—a debilitating and under-recognized condition. The cause of MCAS is unknown and there currently is no cure.\n \n\n The randomized, double-blind, placebo-controlled, parallel-group study will be conducted across high-performing clinical sites in Australia, with regulatory oversight by the Therapeutic Goods Administration (TGA) and relevant Human Research Ethics Committees (HREC). iNGENū CRO is managing full trial execution including protocol refinement, regulatory and ethics submissions, site activation, clinical monitoring, and data management.\n \n\n “This study is a testament to what can be achieved when operational excellence and scientific innovation come together,” said\n \n Dr. Sud Agarwal\n \n , Chief Medical Officer of iNGENū CRO. “Patients with MCAS-related nociplastic pain often have no effective treatment options. By designing and operationalizing this trial in Australia, iNGENū CRO is helping to fast-track potentially transformative therapies through the clinical development pipeline.”\n \n\n The investigational therapy being studied is intended to target the neuroimmune pathways implicated in both mast cell dysregulation and centrally mediated pain processing. Primary and secondary endpoints will assess changes in patient-reported pain, global functioning, safety, and biomarker response.\n \n\n FSD202, an investigational drug containing ultra-micronized palmitoylethanolamide (PEA), shows promise in treating a broad sp...

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