FSD Pharma (NASDAQ: HUGE) (CSE: HUGE) (FRA: 0K9A), a life-sciences holding company dedicated to building a portfolio of assets and biotech solutions, announced that it has submitted an investigational new drug (“IND”) application with the U.S. Food and Drug Administration and Health Canada. The application is for the FDS-PEA and includes details of a planned phase 2 clinical trial of the substance for the treatment of a yet-to-be-disclosed inflammatory disorder. The announcement also noted that the company recently completed the sale of its cannabis production facility in Ontario, which completed the company’s departure from the cannabis sector and transition into becoming a globally recognized biotechnology firm. The IND application represents a “significant milestone” in the company’s drug-development efforts as the company anticipates initiating efficacy trials. In addition, FSD Pharma has been building world-class development and advisory teams comprised of highly qualified scientists, regulatory and medical professionals as it works to advance its three novel drug candidates, which are designed to meet unmet medical needs in areas such as muscular sclerosis, depression disorders and inflammatory disorders. “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,” said FSD Pharma cofounder and president Zeeshan Saeed in the press release. “No treatment currently exists to target neurodegeneration, Major Depressive Disorder is an indication in desperate need for new therapeutic approaches, and, as aforementioned, there are no PEA-based drugs approved by the FDA either. That said, we have unique drug candidates that have the potential to revolutionize patient outcomes in each of these notoriously hard-to-treat diseases via innovative mechanisms of action.”
To view the full press release, visit https://ibn.fm/rmvFw
About FSD Pharma Inc.
FSD Pharma, with only 38.4 million shares issued or outstanding, is a biotechnology company with three drug candidates in different stages of development. FSD BioSciences Inc., a wholly owned subsidiary, is focused on pharmaceutical research and development of its lead compound, ultramicronized palmitoyl ethylamine (“PEA”) or FSD-PEA, formerly called FSD-201. Lucid Psycheceuticals Inc. is a wholly owned subsidiary focused on the research and development of its lead compounds, Lucid-PSYCH (formerly Lucid-201) and Lucid-MS (formerly Lucid-21-302). Lucid PSYCH is a molecular compound identified for the potential treatment of mental health disorders. Lucid-MS is a molecular compound identified for the potential treatment of neurodegenerative disorders. For more information about the company, please visit www.FSDPharma.com.
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