Revive Therapeutics Ltd. (OTCQB: RVVTF) (CSE: RVV) gave an update last week on the company’s U.S. Food & Drug Administration (FDA) Phase 3 clinical trial (NCT04504734) to evaluate the safety and efficacy of Bucillamine, an oral drug with anti-inflammatory and antiviral properties, in patients with mild to moderate COVID-19.
Following Revive receiving positive comments from the FDA in regards to the company’s request to determine and agree on the Study’s potential new primary efficacy endpoints and the company’s submission of a Data Access Plan (“DAP”) to the FDA, the FDA has accepted the DAP to allow for the unblinding of the pre-dose selection data. The company will now proceed to unblind the pre-dose selection data to potentially support the amended Study protocol with the new primary efficacy endpoints. The proposed new primary efficacy endpoints may include the rate of sustained clinical resolution of symptoms of COVID-19, which addresses the shift in COVID-19 clinical outcome observed over the course of the pandemic, and, therefore, to have more meaningful study endpoints for the FDA to consider for potential Emergency Use Authorization.
The Center for East-West Medicine, at the University of California Los Angeles (UCLA) applied to the US Food and Drug Administration (FDA) in April 2020 for approval to conduct 2 randomized phase 1 trials. According to the JAMA Network, the double-blind, placebo-controlled studies would evaluate the safety and feasibility of treating mild to moderate COVID-19 with either medicinal mushrooms, which have a long history as natural therapeutics for pulmonary disease, or a Chinese herb formulation that’s widely used there as a COVID-19 remedy. JAMA reported that the FDA ultimately sanctioned the MACH-19 (Mushrooms and Chinese Herbs for COVID-19) trials, which are now underway at UCLA and UCSD and are supported by the Krupp Endowed Fund. Meanwhile, a third MACH-19 trial is investigating the use of medicinal mushrooms as an adjuvant to COVID-19 vaccines.
“Researchers are currently conducting in vitro and animal studies with natural products to evaluate direct antiviral activity or to address COVID-19 sequelae,” D. Craig Hopp, PhD, deputy director of the Division of Extramural Research at the National Center for Complementary and Integrative Health (NCCIH), said in an interview. But the MACH-19 treatment trials are unique, he noted, because they’re evaluating natural products among humans with acute SARS-CoV-2 infection.”