iNGENū CRO Partners with Quantum BioPharma to Launch Pioneering Australian Clinical Trial for Chronic Nociplastic Pain in MCAS Patients
Study Aims to Expedite Potentially Transformative Therapies By Assessing Safety and Efficacy of FSD202
Melbourne, Australia, June 02, 2025 (GLOBE NEWSWIRE) -- iNGENū CRO, 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.
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.
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.
“This study is a testament to what can be achieved when operational excellence and scientific innovation come together,” said Dr. Sud Agarwal, 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.”
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.
FSD202, an investigational drug containing ultra-micronized palmitoylethanolamide (PEA), shows promise in treating a broad spectrum of inflammatory diseases, including MCAS/MCAD. This potential is especially significant given that chronic inflammatory conditions are the leading cause of death worldwide.
About Quantum BioPharma Ltd.
Quantum BioPharma (NASDAQ: QNTM) is a biopharmaceutical company dedicated to building a portfolio of innovative assets and biotech solutions for the treatment of challenging neurodegenerative and metabolic disorders and alcohol misuse disorders with drug candidates in different stages of development. Through its wholly owned subsidiary, Lucid Psycheceuticals Inc. (“ Lucid ”), Quantum BioPharma is focused on the research and development of its lead compound, Lucid-MS. Lucid-MS is a patented new chemical entity shown to prevent and reverse myelin degradation, the underlying mechanism of multiple sclerosis, in preclinical models. Quantum BioPharma invented unbuzzd™ and spun out its OTC version to a company, Celly Nutrition Corp. (“Celly Nutrition”), led by industry veterans. Quantum BioPharma retains ownership of 22.95% (as of December 31, 2024) of Celly Nutrition at www.unbuzzd.com. The agreement with Celly Nutrition also includes royalty payments of 7% of sales from unbuzzd™ until payments to Quantum BioPharma total $250 million. Once $250 million is reached, the royalty drops to 3% in perpetuity. Quantum BioPharma retains 100% of the rights to develop similar products or alternative formulations specifically for pharmaceutical and medical uses. Quantum BioPharma maintains a portfolio of strategic investments through its wholly owned subsidiary, FSD Strategic Investments Inc., which represents loans secured by residential or commercial property.
For more information on Quantum BioPharma, please visit www.quantumbiopharma.com.
About iNGENū CRO
iNGENū CRO is a globally active, Asia-Pacific-headquartered Contract Research Organization supporting biotech and pharmaceutical clients with end-to-end clinical trial solutions. Specializing in complex, multinational trials and innovative therapeutic areas, INGENU delivers regulatory, operational, and technological excellence across Australia, Malaysia, Singapore, and the UK.
For more information on iNGENū CRO, please visit www.ingenucro.com.
Media Contact:
iNGENū CRO
Amanda De Vito
Global Head of Sales and Marketing
Email: amanda.devito@ingenucro.com
Quantum BioPharma
Zeeshan Saeed
Founder, CEO and Executive Co-Chairman of the Board
Email: zsaeed@quantumbiopharma.com
Name: Amanda De Vito Email: amanda.devito@ingenucro.com Job Title: Global Head of Sales and Marketing
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