FSD Pharma (CSE:HUGE, NASDAQ:HUGE) Inc said it has submitted Investigation New Drug (IND) applications to the US Food and Drug Administration (FDA) and Health Canada for its planned Phase 2 clinical trial of FSD-201 for the treatment of a yet-to-be-disclosed inflammatory disorder.
The biotech noted 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.
In a statement, FSD Pharma president Zeeshan Saeed said the submissions to the FDA and Health Canada for FSD-201 represented a significant milestone in the company's drug development efforts.
READ: FSD Pharma closes $16.4M sale of former cannabis processing plant
“With our elite team and solid cash position, we find ourselves in a strong position initiating the efficacy trials with FSD-201,” Saeed said. “Further details on the clinical trial will be released as soon as the applications complete their review processes, and the clinical trial commences.”
The company has also provided shareholders insights into the company’s plans as it looks to the second half of 2022, highlighting the recent sale of its former cannabis production facility in Cobourg, Ontario for $16.4 million.
FSD Pharma said this sale grew the company’s cash on hand to approximately $50 million and completed its transition away from the cannabis industry to focus on its pipeline of novel therapeutics for inflammatory, neurodegenerative, and neuropsychiatric diseases.
“Over the last year, we have strategically exited the cannabis business, whilst making a generous profit on the sale of the Cobourg facility and in the process, providing sufficient capital for at least three years of operations and clinical trials,” Saeed said.
FSD Pharma interim CEO Anthony Durkacz added that the company was focused on creating shareholder value while mitigating risk.
“All our efforts are concentrated on optimally structured trials that hit their primary endpoints, which we believe will have a cascade effect on potential partners, suitors, and a market valuation that is an accurate reflection of our company. We recognize that Wall Street has under-appreciated the biotech sector and that we are lumped into the mix; that we cannot control. What we can control is efficient execution of our model, assembling a team with a lengthy biotech track record of success to provide guidance, and responsibly managing budgets," he said.
Based in Toronto, FSD Pharma is a biotechnology company with three drug candidates at different stages of development.
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