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FSD Pharma Inc. (NASDAQ:HUGE) (CSE:HUGE) (FRA: 0K9A) ("FSD Pharma" or the "Company"), a biopharmaceutical company dedicated to building a portfolio of innovative assets and biotech solutions to address ailments affecting millions worldwide, today announces 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. The trial and its status are available on ClinicalTrials.gov (Identifier: NCT05652907).
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.
"FSD201 is a unique proprietary formulation of palmitoyl ethanolamide, and already received the new molecular entity (NME) designation for a potential 505(b)(1) application to the US FDA. This is attractive because of the potential exclusive regulatory access to the US market. Our clinical team put in a lot of thought into exploring unmet needs in inflammatory disorders and associated conditions. We are excited to evaluate the efficacy and safety of FSD201 in the treatment of chronic widespread musculoskeletal nociplastic pain associated with idiopathic MCAS, a disease that has challenged caregivers and researchers since the first case was diagnosed in 2007, and potentially millions of patients have a significantly reduced quality of life," said Dr. Lakshmi P. Kotra, Head of FSD Pharma's FSD Biosciences and CEO of Lucid Psycheceuticals. "Owing to the complexity of the disease, the therapeutic market is grossly underserved, presenting us with an opportunity as a pioneer in the space to provide a novel therapeutic option to scores of MCAS patients desperately in need of safe alternatives to the current standard of care. We feel we are in a position with only a handful of companies conducting clinical trials for this indication."
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.1 The cause of MCAS is unknown and there is no cure.
1 https://www.jacionline.org/article/S0091-6749(17)31025-4/pdf
FSD also announces the grant of stock options to directors and officers of the Company to purchase up to an aggregate of 2,000,000 Class B subordinate voting shares in accordance with the Company's stock option plan and subject to vesting terms. The options are exercisable at a price of C$1.30 per share and will expire five years from the date of grant. Certain Independent directors were granted 400,000 PSU's.
