Revive Therapeutics Receives Approval from FDA & Gears up for IRB Approval & COVID-19-focused Clinical Trial

Revive Therapeutics Receives Approval from FDA & Gears up for IRB Approval & COVID-19-focused Clinical Trial TrialsiteN

A specialty drug company called Revive Therapeutics Ltd reports that the U.S. Food & Drug Administration (FDA) has approved their bid to proceed with a Phase 3 clinical trial to evaluate Bucillamine’s safety and efficacy in patients with mild-to-moderate COVID-19. The company recently submitted its clinical trial protocol for the Institutional Review Board (IRB) approval. Moreover, the company is pursuing the FDA Expanded Access Program (Compassionate Use) so that COVID-19 patients can get access to their investigational drug Bucillamine for those that meet the study protocol. The company expects to commence patient enrollment in the trial by September. This company is traded as a micro-cap stock. Although it appears to have some potential, it also represents a considerable risk—only those individuals with a strong understanding of the risks and financial wherewithal (e.g., accredited investor) should ever participate in micro cap biotech venture investment.

Central IRB Advarra Participation

The company selected Advarra, a central IRB, and Michael Frank, the company’s CEO, reports “We are continuing to make strong progress in our Phase 3 clinical trial in COVID-19 and with the submission of the Phase 3 study protocol to Advarra, a premier IRB services company in North America, for review and approval, it will enable us to select key clinical sites in the U.S. and proceed with site initiation visits to allow for the selected U.S. clinical locations to enroll patients.” 

What is Bucillamine?

Bucillamine is an antirheumatic agent developed from tiopronin. Activity is mediated by the two thiol groups that the molecule contains. Researchers in America have demonstrated positive transplant prevention properties. It’s involved with a COVID-19 drug repurposing effort mentioned herein.

With a well-known safety profile, the drug has been prescribed to treat rheumatoid arthritis in Japan and South Korea for over 30 years. Known to be a cysteine derivative with two thiol groups that is 16-fold more potent than NAC as a thiol donor in vivo, making it superior function in restoring glutathione, and hence evidences a possible regiment to prevent acute lung injury during influenza infection. Moreover, the drug evidences an ability to stop oxidative and reperfusion injury in heart and liver tissues.

Shown to have proven safety and mechanism of action comparable to NAC, it has a higher potency. The U.S. FDA approved Revive Therapeutics Ltd. to proceed with a randomized, double-blind, placebo-controlled confirmatory Phase 3 clinical trial protocol to evaluate the drug’s safety and efficacy in patients with mild-to-moderate COVID-19.

See the link to more from the company.

The Study

This study Phase 3, multicenter, randomized, double-blind, placebo-controlled clinical trial NCT04504734 investigates Bucillamine (2 dosage levels) in patients with mild-moderate COVID-19.

The study commences today, August 30, 2020, and runs through May 2021. The study looks at two outcomes including 1) primary outcome measure of the time frame from the time of the first dose through 28 days post-randomization measuring the proportion of patients meeting a composite endpoint of hospitalization or death; and 2) secondary outcome measure of safety, concerning changes in adverse events from baseline to end of the study. Inclusion and exclusion criteria can be reviewed here.

About the Sponsor

Publicly traded under the symbol (TSX VENTURE: RVV) (OTCQB: RVVTF), Canada-based Revive Therapeutics Ltd is focused on the research, development, and commercialization of novel therapies and technologies for the medical cannabis and pharmaceutical sectors. The company’s stock went public back in 2013. The company was merged with another cannabis venture in 2019 as an ugly crash in cannabis companies proceeded.  

The company presentation shows a significant patent portfolio and pipeline based primarily on CBD and hallucinogenic Psilocybin. The company’s micro-cap stock represents a high risk but at such low prices potential for gains—but high risk.