Revive Therapeutics has received approval from the US Food and Drug Administration (FDA) to conduct a Phase III clinical trial of Bucillamine in patients with mild to moderate Covid-19.
Bucillamine is indicated to treat rheumatoid arthritis in Japan and South Korea.
In Covid-19 patients, the drug is expected to increase glutathione activity and other anti-inflammatory activity in order to mitigate the complications of the disease in the lungs.
The multi-centre, randomised, double-blind, placebo-controlled Phase III trial will assess the safety and efficacy in up to 1,000 patients. Participants will be given 100mg or 200mg three times a day or placebo for up to 14 days.
Primarily, the study will track the frequency of hospitalisation or death in patients treated with Bucillamine compared to those on placebo.
The primary endpoint is the proportion of subjects achieving a composite endpoint of hospitalisation or death from the time of first dose to day 28 after randomisation.
Efficacy will be evaluated based on clinical outcome, disease severity, supplemental oxygen use and progression of Covid‑19.
The safety assessment will include pre-treatment adverse events, treatment-emergent adverse events, laboratory values, vital signs, and peripheral oxygen saturation.
An Independent Data and Safety Monitoring Board (DSMB) will conduct an interim analysis after 210 patients receive treatment and are followed up for 28 days after randomisation.
Revive Therapeutics CEO Michael Frank said: “The FDA approval of the Phase III study to evaluate Bucillamine in the treatment of patients with mild-moderate Covid-19 is a tremendous milestone for Revive and I am very proud of the dedication of our team and partners to bring forward a potential new treatment option for patients with a confirmed diagnosis of Covid-19 globally.
“We thank the FDA for recognising the importance of this Phase III study and we are now focused on executing on our plans for initiating the clinical trial in an expeditious manner.”
The company filed a clinical trial application with Health Canada in June to conduct a Phase III trial of Bucillamine to treat patients with mild to moderate Covid-19.