The biotech said the FDA has authorized a randomized, controlled, multicenter study on 352 patients
Inc () (CSE:HUGE.CN) (FRA:0K9A) announced on Monday that the US Food and Drug Administration (FDA) has authorized the initiation of a Phase 2 study 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 it will start dosing patients in October this year. FSD observed that in some cases of COVID-19, there is an “over-exuberant inflammatory response” that may lead to a cytokine storm and ultimately death. Therefore, it is developing FSD-201 for its anti-inflammatory properties to potentially address the cytokine storm associated with acute lung injury in hospitalized COVID-19 patients.
"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," FSD Pharma CEO Raza Bokhari said in a statement.
READ: FSD Pharma files Phase 2 clinical trial IND with the FDA for its lead candidate micro-PEA to treat coronavirus patients
“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,” he added.
Dr Bokhari said 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," added Dr Bokhari.
The trial is designed to be a randomized, controlled, double-blind, multicenter study, conducted on 352 patients to assess the effectiveness and safety of FSD-201 dosed at 600 mg or 1,200 mg twice daily, together with standard of care (SOC), versus SOC alone in hospitalized patients with documented COVID-19.
The company said patients in the study will have symptoms consistent with “influenza/coronavirus signs" (like fever, dry cough, difficulty breathing) and be newly documented positive COVID-19 cases.
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.
FSD said it is not making any implied claims that its product has the ability to eliminate or contain COVID-19 at this time.
Contact the author Uttara Choudhury at uttara@proactiveinvestors.com
Follow her on Twitter: @UttaraProactive
