FSD Pharma Gets Ethics Approval for Phase-1 Lucid-MS Trial in Australia

June 27, 2024 / FSD Pharma Inc., a biopharmaceutical company, has announced approval from the Human Ethics Review Committee (HREC) in Australia for its clinical trial titled "A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Safety and Pharmacokinetics of Lucid-21-302 in Healthy Adult Participants."

Lucid-21-302 is a pioneering, non-immunomodulatory, neuroprotective compound designed to treat multiple sclerosis (MS). This patented New Chemical Entity aims to inhibit demyelination, a common factor in MS and other neurodegenerative diseases that harm the myelin sheath around nerve fibers in the central nervous system.

Dr. Andrzej Chruscinski, Vice-President, Scientific and Clinical Affairs at FSD Pharma, expressed enthusiasm about the approval, noting it as a significant milestone in Lucid-21-302's clinical journey.

In related news, FSD Pharma has issued 400,000 Class B Subordinate Voting shares at $0.30 per share to settle a $120,000 debt with arm's length creditors.

FSD Pharma is dedicated to developing a diverse portfolio of innovative treatments for neurodegenerative and metabolic disorders, and alcohol misuse. The company’s main focus, through its subsidiary Lucid Psycheceuticals Inc. ("Lucid"), is the research and development of Lucid-MS (previously Lucid-21-302). Lucid-MS has demonstrated potential in preclinical studies to prevent and reverse myelin degradation, a core issue in multiple sclerosis.

Additionally, FSD Pharma has developed a product called unbuzzd™, which has been spun out to Celly Nutrition, a company led by industry experts. FSD Pharma retains a 25.71% ownership in Celly Nutrition as of March 31, 2024. The agreement also includes royalty payments to FSD Pharma, initially at 7% of sales until cumulative payments reach $250 million, after which the royalty rate drops to 3% indefinitely.

Besides its main ventures, FSD Pharma has significant tax loss carryforwards amounting to approximately CAD$130 million, which could be used to offset future tax liabilities. The company also maintains exclusive rights to develop similar or alternative formulations for pharmaceutical and medical use.

FSD Pharma has also diversified its investments through its wholly-owned subsidiary, FSD Strategic Investments Inc., focusing on loans secured by residential or commercial properties.

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