By: IPP Bureau
Last updated : June 04, 2025 12:56 pm
The trial targets MCAS/MCAD, an under-recognized, debilitating condition with an unknown cause and no cure
iNGENū CRO, a Contract Research Organization (CRO) in the Asia-Pacific region, announces its leadership role in a Phase 2 clinical trial in partnership with Quantum BioPharma, focused on chronic nociplastic pain associated with idiopathic Mast Cell Activation Syndrome/Disorder (MCAS/MCAD).
The trial targets MCAS/MCAD, an under-recognized, debilitating condition with an unknown cause and no cure. The randomized, double-blind, placebo-controlled study will be conducted at high-performing clinical sites in Australia, under Therapeutic Goods Administration (TGA) and relevant Human Research Ethics Committees (HREC) oversight. iNGENū CRO will manage full trial execution, including protocol refinement, regulatory submissions, site activation, 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 study will evaluate the investigational therapy targeting neuroimmune pathways involved in mast cell dysregulation and pain processing. Primary and secondary endpoints will assess pain, global functioning, safety, and biomarker response.
FSD202, an investigational drug with ultra-micronized palmitoylethanolamide (PEA), shows promise in treating a broad spectrum of inflammatory diseases, including MCAS/MCAD, offering hope for chronic inflammatory conditions, a leading cause of death worldwide.