Inc () () is a publicly-traded holding company that owns subsidiary FSD Pharma BioSciences Inc, a specialty biotech pharmaceutical R&D firm focused on developing multiple applications of its lead anti-inflammatory drug FSD-201.
The drug is now one of several therapeutics being advanced that could help reduce severe and deadly lung infection in coronavirus (COVID-19) patients.
Known as ultra-micronized PEA, the drug is a naturally occurring fatty acid similar to an endocannabinoid, one of a suite of molecules found in cannabis that targets endocannabinoid (CB2) receptors in the human body. The company holds exclusive worldwide rights to the drug that has been used for 40 years to fight respiratory infections.-- expect in Italy and Spain, where PEA is prescribed as a medical-food supplement to treat chronic inflammation.
FSD-201 works by reducing lung inflammation caused by small proteins called cytokines that are central to the “cytokine storm” phenomenon, where the body attacks its own cells rather than just fighting off the COVID-19 disease caused by the SARS-CoV-2 virus. This so-called storm of an "over-exuberant" inflammatory response causes acute lung injury in hospitalized patients and is a leading cause of death for those infected.
FSD Pharma, which recently began liquidating its cannabis-production operations in Canada to focus all its energies and resources on developing FSD-201, has had several successes in advancing the drug toward potential commercialization.
In fact, the US Food and Drug Administration (FDA) has authorized the initiation of a Phase 2 study of FSD-201 on COVID-19 patients. The company plans to start oral dosing (tablets) more than 300 patients in October this year. The company successfully completed a Phase 1 first-in-human safety and tolerability study for FSD201 in Australia.
In recent months, FSD Pharma has raised some $40 million in financing to fund FSD-201 and other R&D initiatives.
It also expects to get about $15 million for its shuttered, 600,000-square-foot cannabis production and warehouse facility in Ontario. And it has been sitting on $2 million worth of unsold cannabis. It also has been selling off assets stemming from its former cannabis operations.
Nevertheless, all eyes are on FSD-201 and the upcoming Phase 2 COVD-19 trial.
It is designed to be a randomized, controlled, double-blind, multicenter study conducted on 352 patients to assess the effectiveness and safety of the drug. Patients will be dosed at 600 milligrams or 1,200 mg twice daily, together with standard of care (SOC), versus SOC alone in hospitalized patients with documented COVID-19. Patients in the study will have symptoms consistent with influenza and/or coronavirus signs like fever, dry cough, and difficulty breathing.
The primary objective of the trial is to determine whether FSD-201 plus SOC provides a “significant improvement” in the clinical status of patients which includes shorter time to symptom relief.
Secondary objectives include determining whether FSD-201 plus SOC demonstrates additional benefit in terms of safety, help in bringing down fever, length of time to improve oxygen saturation, and "length of time to clinical progression, including time to mechanical ventilation or hospitalization, and length of hospital stay."
The company said the endpoint is "cytokine clearance" as measured by the Enzyme-Linked Immunosorbent Assay, or ELISA test. The treatment period for patients in the FSD-201 trial is 14 days and the primary endpoint will be determined at 28 days.
Meanwhile, the company has strengthened its management team by appointing three key executives. It tapped Donal Carroll as chief financial officer and Dr Sandra Lottes as vice president and head of clinical research of the BioSciences division. It also appointed Shahzad Shah as chief operating officer.
Release results of Phase 2 study of FSD-201 Further study of drug to treat osteoarthritis in the knee, endometriosis, and chronic pain (non-opioid)“Commencing a phase 2 clinical trial to treat hospitalized COVID-19 patients is a major milestone achieved by our pharmaceutical team led by Dr Edward Brennan and a huge step forward for FSD Pharma,” said CEO Dr Raza Bokhari in a recent statement.
"We are joining the global fight against the deadly SARS-CoV-2 virus with a hope to demonstrate down-regulation of the over-expressed immune response in COVID-19 patients leading to better treatment outcome. FSD201 is formulated as a tablet for oral dosing and is a safe compound with no known serious adverse side effects. Numerous studies over the past 40 years have validated micronized PEA for its efficacy and safety in the treatment of, and prophylactic effects with respect to, other respiratory infections.”