Mighty micro PEA

TORONTO—FSD Pharma, a medical cannabis firm, has joined the race to create a COVID-19 treatment using cannabinoids. The company recently announced that the U.S. Food and Drug Administration (FDA) had approved its application proposal to conduct clinical trials involving a drug called ultramicronized palmitoylethanolamid (or micro PEA) that includes synthetic molecules that mimic cannabinoids.

According to Philadelphia-based physician and FSD CEO Dr. Raza Bokhari, micro PEA is a naturally occurring fatty acid that can be purchased over the counter. Its original form was not bioavailable.

Bokhari explained that micro PEA is believed to act as an anti-inflammatory. It was promoted between 1969 and 1979 in former Czechoslovakia as a treatment for influenza and the common cold. Clinical trials conducted at the time demonstrated that PEA was an effective prophylactic for respiratory infections, with no known side effects. According to the researchers involved in the studies, it could act as a quick therapeutic answer if there was a flu epidemic.

Currently, the drug is available in Italy as a nutraceutical that is used to treat chronic inflammation. It has been dispensed in Italy and Spain as a prescription-based medical food supplement since 2004.

An Italian pharmaceutical firm, Epitech Group, owned the rights to the drug and sold it under the names Normast and Pelvilen. Earlier this year, FSD purchased the worldwide rights to license the formulation from Epitech for $17.5 million. FSD then re-branded it as FSD-201 to explore the opportunity to develop and advance research and development on the formulation per FDA guidelines.

Bokhari emphasized that FSD does not claim cannabinoids, synthetic or plant-based, are an alternative for COVID-19 treatment. However, he noted that FSD-201 modulates the endocannabinoid system as “a naturally occurring fatty acid” by targeting CB2 receptors, which are believed to affect pain and inflammation in humans. “Severe COVID-19 is characterized by an over-exuberant inflammatory response—an overexpressed immune response—that may lead to a cytokine storm. FSD-201 is not a virus killer, but we believe it can mitigate that immune response, which can be fatal. We believe that FSD-201 can down-regulate the immune system.”

He added that, sometimes, “the overexpressed immune system is the killer, not the virus. There can be tissue damage and accumulation of fluids, which micro PEA can control.”

Previous research published in Preprints suggested that marijuana could manipulate the main cellular gateway by which COVID-19 enters the system. Researchers wrote that a novel combination of cannabinoids “may become a useful addition to the treatment of COVID-19.” Israeli researchers have also launched clinical trials into whether marijuana terpenes could affect and/or prevent COVID-19. The FSD Phase 1 study also validated considerable scientific literature already published in the European Union that claims safety and tolerability of micro PEA.

“Our immediate plans for FSD201 include submitting our Phase 1 trial results for publication in a peer-reviewed journal and advancing this compound into a Phase 2a proof-of-concept trial for the treatment of COVID-19,” continued Bokhari. “The U.S. Food and Drug Administration recently gave the company permission to submit an Investigational New Drug application for the use of FSD201 to treat COVID-19. We contacted the FDA after becoming aware that Italian physicians and scientists were advocating for use of ultramicronized PEA for patients suffering from symptoms of COVID-19, based on the drug’s mechanism of action as a potent and safe anti-inflammatory agent that reduces the production of pro-inflammatory cytokines and may help mitigate a cytokine storm.”

Bokhari anticipates that FSD will be able to initiate a double-blind study with hospital patients by the end of the year. While he said the company was well capitalized for the trial without government funding, he hopes to have a strategic partner in place for commercialization.