FSD Pharma Archives - Green Market Report

FSD Pharma Inc. (Nasdaq: HUGE) (CSE: HUGE.CN)announced that it has notified Health Canada of the company’s decision to forfeit the licenses of its wholly-owned subsidiary, FV Pharma, Inc. and suspend all activities by FV Pharma within 30 days of the notification date. FSD Pharma said it has begun the process of liquidating all FV Pharma assets, including the sale of the company’s cannabis production facility in Cobourg, Ontario.

Shareholders are apparently happy with the move as the stock is up over 60% on the news and was lately selling at $6.04.

“It is now clear to us that our shareholder value is best served in closing down our medicinal-grade cannabis operation in Cobourg, Ontario and reinforcing steps to advance pharmaceutical R&D efforts on our lead compound FSD201 (ultra-micronized PEA) and continuing to explore the acquisition of other compelling compounds to expand our drug development pipeline,” said Raza Bokhari, MD, Executive Co-Chairman & CEO.

“Our pharmaceutical R&D team led by Dr. Edward Brennan is actively working to submit an Investigational New Drug Application (IND) to the FDA for the use of FSD201 (ultra-micronized PEA) to treat hospitalized COVID-19 patients by down-regulating the over-expressed pro-inflammatory cytokine immune response to SARS-CoV-2 virus infection. We are hopeful to initiate the phase 2 clinical trial before the end of this year and remain cautiously optimistic that our study may improve treatment outcome for COVID-19 patients.”

The company said it is not making any express or implied claims that its product has the ability to eliminate, cure, or contain the COVID-19 (or SARS-2 Coronavirus) at this time.

COVID Pivot

In June, FSD said it was shifting its attention towards COVID. “Our immediate plans for FSD201 include submitting these 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,” said Dr. 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.”

The company announced a $20 million at the market offering just a few weeks ago. The company said at the time that it would use the proceeds to continue the advancement of the near-term objectives with respect to its R&D program for the commercialization of ultramicronized-palmitoylethanolamide of FSD201.

Canadian licensed producer FSD Pharma Inc. (Nasdaq: HUGE) has made a pivot in order to assist in the treatment of the deadly COVID-19 virus. The company announced favorable topline results from its Phase 1 randomized, double-blind, placebo-controlled study of ultramicronized palmitoylethanolamide (PEA), or FSD201. The company is hoping that with positive Phase 2 results, it can be used to treat COVID-19.

“We are delighted to be reporting favorable topline findings from our Phase 1 first-in-human safety and tolerability study with FSD201. I congratulate our pharmaceutical team, led by Dr. Edward Brennan. This study has also successfully validated the considerable scientific literature published over the years in Europe that claims safety and tolerability of micro-PEA,” said Raza Bokhari, MD, Executive Co-Chairman & CEO.

Historically (between 1969 and 1979), PEA used to treat patients with influenza and the common cold in Czechoslovakia. At the time, six randomized, double-blind, placebo-controlled clinical trials were conducted that demonstrated PEA was safe and effective for the treatment of respiratory infections. FSD Pharma attained the exclusive, worldwide rights (except for Italy and Spain) of PEA (which targets the CB2 receptor of the endocannabinoid system) through the acquisition of Prismic Pharmaceuticals in June 2019.

“Our immediate plans for FSD201 include submitting these 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 Dr. 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.”

Small Study Group

FSD said that this was a single-site study conducted at the Alfred Hospital, part of the Alfred Health group of hospitals serving the state of Victoria in Australia and enrolled 48 healthy adult men and women. The trial sequentially tested single ascending doses ranging from 600 mg to 2400 mg tablets and multiple ascending doses ranging from 600 mg to 1200 mg tablets administered twice daily for 7 consecutive days. The single ascending dose subjects also were tested for food effects.

The study found ultramicronized PEA to be safe and well-tolerated. Mild and self-limiting side effects were reported and were deemed unlikely to be related to study drug. There were no abnormal laboratory findings or ECGs observed during the study and no serious adverse events were reported. No subjects withdrew due to an adverse event and all eligible subjects completed all doses. The pharmacokinetic profile of FSD201 in this study is still being analyzed. The study was led by principal researcher Jason Lickliter, MD, Chief Medical Officer of Nucleus Network, Australia.

The company is not making any express or implied claims that its product has the ability to eliminate, cure, or contain the Covid-19 (or SARS-2 Coronavirus) at this time.