FSD Pharma Inc. has submitted to the US Food and Drug Administration (FDA) an Investigational New Drug Application (IND) for the use of FSD201, or ultramicronized palmitoylethanolamide, or ultramicronized PEA, to treat patients with severe cases of COVID-19. Severe COVID-19 is characterized by an over-exuberant inflammatory response that may lead to a cytokine storm and ultimately death.
According to an FSD Pharma representative, FSD201 is an ultramicronized form of PEA, a naturally occurring fatty acid that acts as one of the body’s inflammatory modulators. The ultramicronized formulation was developed by Italian firm Epitech Spa, which currently markets the product as a food for special medical purposes.
Currently, ultramicronized PEA reportedly is used in Italy to treat several chronic inflammatory conditions, including neuropathic pain and chronic low back pain. FSD Pharma squired the worldwide rights (excluding Italy and Spain) to develop and market ultramicronized PEA in June of 2019
FSD Pharma is focused on developing FSD201 for its anti-inflammatory properties to avoid the cytokine storm associated with acute lung injury in hospitalized COVID-19 patients.
“Cytokine storm is where pro-inflammatory cytokines overwhelm the body’s normal homeostatic control of the inflammatory process has been demonstrated to be key in the morbidity and mortality of COVID-19 disease, where unchecked inflammation leads to respiratory failure, disturbances in hemostasis, and ultimately cardiovascular collapse,” the FSD Pharma spokesperson told OSP.
The FSD201 COVID-19 trial reportedly will be a randomized, controlled, double-blind, multicenter study, conducted at 25 to 30 sites in North America to assess the efficacy and safety of FSD201 dosed at 600mg or 1200mg twice-daily, together with standard of care ("SOC") compared to SOC alone in hospitalized patients with documented COVID-19 disease.
Additionally, the FSD Pharma spokesperson told us, the company plans to explore potential uses for PEA to treat other diseases.
“PEA has been shown to be effective in many inflammatory conditions. FSD intends to explore other possible indications, in addition to the current COVID-19 trial,” they told us.
Treatment for cytokine storm has been a particular focus in development of potential COVID-19 therapies. Noxopharm recently launched a Phase I clinical trial in Europe to test use of Veyonda to treat cytokine storm and septic shock; Clinical Ink recently helped build and kick off an electronic study environment for the condition.