FSD Pharma takes off as FDA backs Ph IIa COVID-19 candidate trial design

Canada-based biotech FSD Pharma (Nasdaq: HUGE) saw its shares skyrocket 127% to C$9.65 by close of trading Wednesday, after it revealed that the US Food and Drug Administration had given the company permission to submit an Investigational New Drug Application (IND) for the use of its lead candidate FSD-201 (ultramicronized palmitoylethanolamide, or ultramicronized PEA) to treat COVID-19, the disease caused by the SARS-CoV-2 virus.

Severe COVID-19 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. The company has a Phase I first-in-human safety and tolerability trial for FSD-201 currently underway in Australia.

“The 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,” said Dr Raza Bokhari, executive co-chairman and chief executive of FSD Pharma, adding: “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. 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.”