viewFSD Pharma

FSD Pharma wins FDA nod to design Phase 2a clinical trial of its lead candidate micro-PEA to treat coronavirus patients

The trial will be a randomized, controlled, double-blind, US multicenter study to assess the effectiveness and safety of FSD-201, or micro-PEA

FSD Pharma -
FSD Pharma is focused on developing FSD-201, or micro-PEA for its anti-inflammatory properties to avoid the cytokine storm associated with acute lung injury in hospitalized COVID-19 patients

FSD Pharma Inc (NASDAQ:HUGE) (CSE:HUGE.CN) (FRA:0K9A) said Wednesday that the US Food and Drug Administration (FDA) has given the company permission to submit an Investigational New Drug (IND) application for the use of its lead candidate FSD-201, or anti-inflammatory ultra-micronized-palmitoylethanolamide (PEA), to treat coronavirus (COVID-19) patients.

The company said that “severe COVID-19” the disease caused by the SARS-CoV-2 virus, is characterized by an “over-exuberant inflammatory response” that may lead to a cytokine storm and ultimately death. FSD Pharma is focused on developing FSD-201 for its anti-inflammatory properties to avoid the cytokine storm associated with acute lung injury in hospitalized COVID-19 patients.

In a statement, FSD Pharma executive co-chairman and chief executive Raza Bokhari said: “FDA’s permission to design a proof-of-concept study in COVID-19 patients evaluating clinical doses of FSD-201 is a paradigm shift for FSD Pharma and is the result of outstanding work conducted by Dr Edward Brennan, president FSD BioSciences, and his team.”

READ: FSD Pharma kicks off in-human study of micro-PEA in Australia

He added: “We 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 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.”

The FSD Pharma boss said that numerous studies over the past 40 years also validate the efficacy and safety of ultramicronized PEA in the treatment and prophylactic effects in respiratory infections.

“These studies also pointed out that the ease of application of PEA offers the possibility to have a quick therapeutic answer ready in case of a flu epidemic,” Bokhari added.

COVID-19 trial design

Based on the FDA feedback received to date, the company expects the trial will be a randomized, controlled, double-blind, US multicenter study to assess the effectiveness and safety of FSD-201 dosed 600 mg or 1,200 mg twice-daily plus standard of care (SOC) versus SOC alone in symptomatic patients with clinical signs compatible with COVID-19.

“Eligible patients will present with symptoms consistent with influenza/coronavirus signs (fever, dry cough, malaise, difficulty breathing) and/or newly documented positive COVID-19 disease,” the company said in a statement.

FSD Pharma said the primary endpoint is to determine if FSD-201 plus SOC provides a significant improvement and shorter time to symptom relief. Key secondary objectives include determining if FSD-201 plus SOC demonstrates additional benefit in terms of safety, normalization of fever, “improvement of oxygen saturation” and clinical progression mapped by patients getting off mechanical ventilation and getting out of the ICU.

“The exploratory endpoint is cytokine clearance as measured by Enzyme Linked Immunosorbent Assay (ELISA),” said the company.

The treatment period is expected to be 14 days. All patients who experience clinical benefit are expected to continue to receive their assigned treatment until study completion.

Drug's anti-inflammatory profile

The company underlined the fact that “more than 600 scientific papers” attest to the physiological properties of PEA and its role as an endogenous modulator, as well as its pharmacological and therapeutic effects, specifically its anti-inflammatory profile.

The drug works by targeting receptors in patients’ endocannabinoid system. “Saturated acylethanolamides such as PEA (an endogenous congener of AEA) may act in an analogous fashion to modify chronic inflammation in autoimmune disorders,” noted the company.

It said PEA “down-regulates” hyperactive “mast cells, inhibits iNOS expression and nuclear NF-kappa B translocation.”

In addition, PEA has repeatedly been shown to down-modulate excess immune response activity that contributes to the “physiologic derangement induced by viruses and help mitigate the pathogenesis of the cytokine storm,” the group added.

FSD Pharma is a biotech which through its subsidiary FSD BioSciences is focused on developing a pipeline of FDA-approved synthetic compounds targeting the endocannabinoid system of the human body to treat certain diseases of the central nervous system and autoimmune disorders of the skin, GI tract, and the musculoskeletal system. The company has a Phase 1 first-in-human safety and tolerability trial for its lead candidate, FSD-201, currently underway in Australia.

The company is also developing opioid-sparing prescription drugs through its Prismic Pharmaceuticals firm, as well as cannabis cultivation through another subsidiary, FV Pharma.

Headquartered at the former Kraft plant in Cobourg, Ontario, with large expansion potential, FSD also grows medical-grade cannabis at its 25,000 square foot facility in Ontario.

Contact the author Uttara Choudhury at uttara@proactiveinvestors.com

Follow her on Twitter: @UttaraProactive

Quick facts: FSD Pharma

Price: 2.15 CAD

Market: CSE
Market Cap: $66.58 m

Add related topics to MyProactive

Create your account: sign up and get ahead on news and events


The Company is a publisher. You understand and agree that no content published on the Site constitutes a recommendation that any particular security, portfolio of securities, transaction, or investment strategy is...

In exchange for publishing services rendered by the Company on behalf of FSD Pharma named herein, including the promotion by the Company of FSD Pharma in any Content on the Site, the Company receives from said issuer...


FSD Pharma fully funded to continue progress on its Phase 2 study on...

FSD Pharma Inc (NASDAQ:HUGE) (CSE:HUGE.CN) CEO Raza Bokhari tells Proactive the biopharma group is fully funded to continue progress on its Phase 2 study to treat hospitalized coronavirus patients. Bokhari says its most recent fundraising gives the firm $9.5M to conduct the trial, which will...

on 4/11/20

4 min read