Crystal Research Associates has issued an 11-page Quarterly Update on specialty biotech pharmaceutical research and development (R&D) company, FSD Pharma Inc. (HUGE-NASDAQ/HUGE-CSE), detailing the Company's recent news and developments—including its recent permission from the U.S. FDA on June 1, 2020 to submit an Investigational New Drug Application (IND) to use FSD201 to treat COVID-19 (the disease caused by the SARS-CoV-2 virus)—as well as its recent financial position. The report is available for download below.
Snapshot of FSD Pharma Inc.
FSD Pharma Inc. is a publicly traded holding company since May 2018. FSD Pharma BioSciences, Inc. (a wholly-owned subsidiary) is a specialty biotech pharmaceutical research and development (R&D) company focused on developing multiple applications of its lead compound, FSD201 ultramicronized Palmitoyl ethylamine (PEA). Ultramicronized PEA is known to target the cannabinoid-2 (CB2) receptors of the end-cannabinoid system of the human body and acts by down-regulating the pro-inflammatory cytokines to effectuate an anti-inflammatory response.
The Company has successfully completed a Phase 1 first-in-human safety and tolerability study for FSD201, with the compound found to be safe with no serious adverse side effects. This study also validated considerable scientific literature published in the European Union that claims safety and tolerability of micro-PEA. Ultramicronized PEA is being dispensed in Italy and Spain as a prescription-based medical food supplement since 2004.
The Company received permission from the Food and Drug Administration (FDA) on June 1, 2020 to submit an Investigational New Drug Application (IND) to use FSD201 to treat COVID-19, the disease caused by the SARS-CoV-2 virus. Severe COVID-19 is characterized by an over-exuberant inflammatory response that may lead to a cytokine storm and ultimately death. The Company is focused on developing FSD201 for its anti-inflammatory properties to avoid the cytokine storm associated with acute lung injury in hospitalized COVID-19 patients.
FSD’s wholly-owned subsidiary, FV Pharma, is a licensed producer under Canada’s Cannabis Act and Regulations, having received its cultivation license on October 13, 2017 and its full Sale for Medical Purposes license on June 21, 2019. The Company is licensed to cultivate cannabis in approximately 25,000 square feet of its facility in Cobourg, Ontario.
Key Points of FSD Pharma Inc.'s Business
- FSD is seeking to bring innovative prescription products to market that are formulated from its proprietary micro-PEA development platform through independent or concomitant use to address multiple disease conditions.
- Having successfully completed a Phase I first-in-human safety and tolerability trial for FSD201, the Company’s targeted indication for a Phase 2a proof of concept trial is COVID-19 (currently engaged with the FDA to get the IND approved). Additional potential targets for Phase 2 trials include newly-diagnosed osteoarthritis of the knee, endometriosis, and opioid replacement and/or sparing agent.
- COVID-19 has developed into a worldwide pandemic, with Italy being a particular “hotspot.” The Company contacted the FDA in late-March 2020 after becoming aware that several Italian physicians and scientists were advocating for use of ultramicronized PEA for patients suffering from COVID-19 symptoms based on the drug’s mechanism of action as a potent and safe anti-inflammatory agent that reduces the production of pro-inflammatory cytokines.
- FSD Pharma holds exclusive worldwide licensing rights (except Italy and Spain) to ultramicronized-PEA for all conditions in all regulatory categories and plans to submit FSD201 Phase 1 trial results for publication in a peer-reviewed journal.
- The Company holds a strong IP portfolio covering ultramicronized composition of matter and use (2029-34 U.S. expiration).
- As of June 30, 2020, the Company held approximately C$52M in cash and non-cash assets.
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