The trial will be a randomized, controlled, double-blind, US multicenter study to assess the effectiveness and safety of FSD-201, or micro-PEA
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.
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.
Contact the author Uttara Choudhury at [email protected]
Follow her on Twitter: @UttaraProactive
