FSD Pharma Inc. announced recruiting is underway for the Company's Phase 2 clinical trial of FSD201 for the treatment of chronic pain associated with idiopathic MCAS (MCAD) at two clinical sites in the USA, and a Canadian site to be ready to recruit soon. FSD201 is a proprietary anti-inflammatory compound with the potential to address a wide range of inflammatory diseases and associated conditions. FSD201 successfully completed a Phase 1 safety and tolerability trial with topline results.

The multi-center, randomized, double-blind, placebo controlled parallel group study will enroll 60 idiopathic MCAS patients. Per the protocol, patients will receive either 600-milligram tablets of FSD201 or placebo twice daily for 56 consecutive days. The primary outcome is a 30% decrease from baseline to day 28 in the average daily pain intensity.

The trial will also evaluate many secondary outcomes. Mast cells are the first responders of the innate and adaptive immune systems, responding to endogenous factors to play an important role in anaphylaxis and tissue healing. 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, arising from neurogenic inflammation, is associated with MCAS. Symptoms of MCAS can start at any age, but usually begin in adulthood. Due to the ubiquitous nature of mast cells throughout human body tissue, MCAS has the potential to affect every organ system, frequently without showing abnormalities in routine testing and patients suffer from chronic and systemic pain.

Up to 30% of the general population can be affected by disorders related to mast cell activation (atopic disorders). Conversely, mastocytosis and MMAS (monoclonal mast cell activation syndrome) are typically considered rare diseases, affecting 1 in 10,000-20,000 subjects. The cause of MCAS is unknown and there is no cure.