FSD Pharma Inc (CSE:HUGE, NASDAQ:HUGE) revealed that it has received a study may proceed letter for its Investigational New Drug (IND) application from the US Food and Drug Administration (FDA) and notice of authorization from Health Canada for its Phase 2 clinical trial of FSD201.
The Toronto-based biopharma firm said the corresponding study protocol is titled "A Randomized, Double-Blind Placebo Controlled Parallel Group Study of Safety and Efficacy of FSD201 in Patients with Chronic Widespread Musculoskeletal Nociplastic Pain Associated with Idiopathic Mast Cell Activation Syndrome."
In a nutshell, Idiopathic Mast Cell Activation Syndrome (MCAS) is a disorder where unknown triggers release inflammatory mediators and cause a constellation of symptoms from hives, swelling, low blood pressure, and difficulty breathing.
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"We are delighted to receive authorization to proceed with our planned efficacy clinical trial of FSD201 from both FDA and Health Canada. We are working with our clinical sites in the US and Canada to initiate the study and intend to release more details on the study very soon," Dr Lakshmi Kotra, CEO of FSD Pharma subsidiary Lucid Psycheceuticals, said in a statement.
“We believe FSD201 is a compelling drug candidate, and we are actively exploring opportunities for development partners and other synergistic collaborations that will maximize shareholder returns."
The company said that FSD-201, its proprietary formulation of ultra micronized palmitoylethanolamide, or ultramicronized PEA, was shown to be safe and well tolerated during a Phase 1 clinical trial.
FSD Pharma noted that chronic inflammatory diseases are the leading cause of death globally and the World Health Organization (WHO) ranks chronic disease as the greatest threat to human health.
According to FSD Pharma, the immense problem has limited treatment options, which is why it is working relentlessly to bring a new and safe inflammatory treatment option to market.
FSD Pharma has at least three drug candidates at different stages of development.
Contact the author Uttara Choudhury at uttara@proactiveinvestors.com
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