The company is filing an Investigational New Drug application with the FDA for the Phase 3 confirmatory clinical trial of Bucillamine

Revive Therapeutics Ltd (CSE:RVV) (OTCMKTS:RVVTF) has come a long way in just six months under the stewardship ofCEOMichael Frank.That much is apparent from a casual glance at the share price for the year to date.

However, there is an argument to be made that suggests this may just be the start of the journey for this US and Canadian-listed life sciences innovator. For not only does Revive have a (coronavirus) COVID-19possible treatment headedtowards phase III clinical trials, but it also has some unique and interesting intellectual property (IP) that taps into the emerging area of psychedelics.

Also part of the story, but taking a back-seat for now, is its research around the potential uses of cannabidiol (CBD) to treat auto-immune hepatitis, ischemia and reperfusion injury from organ transplantation.

READ:Revive Therapeutics holds pre-CTA meeting with Health Canada for Bucillamine to treat COVID-19 patients

Revivehas a history of repurposing drugs and IP such asBucillamine,a cysteine derivativeanti-inflammatory that has been used for more than 30 years to treatrheumatoid arthritisin Japan and South Korea.

With an impeccable track record for safety, the companys researchers were assessingthe data fromits potential deployment in acute gout flareswhere ithad successfully completed a phase IIUS Food and Drug Administration (FDA)clinical trial.

Thats when more thoughts were given to the use of Bucillamine to treat lung inflammation.

The drug works by helping restore and enhance an antioxidant called glutathione. Revives team soon realized the same anti-inflammatory action that worked in gout and arthritis could possibly be deployed in people suffering lung inflammation as a result of seasonal flu, H1N1, SARS and, crucially, COVID-19.

In April, it applied to the US regulator to carry out a phase II trial in COVID-19and was surprised by the response.

BasedonBucillamines composition, efficacy, safety and history, as well as a previous, successful interaction with the FDA, the drugs watchdog asked Revive to prepare anInvestigational New Drug (IND) submissionfor a phase IIIconfirmatory trialin COVID-19.

Thats a very large milestone and a major study, says Frank.It gives the company a great deal of credibility.

The company is currently incorporating guidance provided by the US regulator intoits INDpackage, which should beready and submittedby the end of the month,Frank adds.

Another development that is exciting investors is the companys move into psychedelics, which appears incredibly well-timed.

Last year the FDA approvedesketamine to treat depression, making it the first-ever psychedelic drug to receive the regulatory green light in the US, with UK authorities giving their approval for the ketamine-like drug a few months later.

MDMA, meanwhile, has been given breakthrough therapy designation by the US regulator for post-traumatic stress disorder (PTSD), as has psilocybin, the psychoactive found in mushrooms, which is being developed as an alternative to traditional antidepressants.

In March, Revive announcedit was acquiring Psilocin Pharma Corp in an all-paper deal worth $2.75 million. Its focus is psilocybin-based treatments forvariousmedical needs, which includes rare and orphan indications.

Reviveis working with the University of Wisconsin on some new delivery technology that could add another dimension to the research and discoveries to date.

We want to build a better product, with more favorable onset and delivery of psilocybin and then move it down the clinical path, says Frank.

And thats crucial, because like many others in this new and flourishing area of drug discovery, the plan is to formally follow the highly regulated route to market.

In doing so the potential reward could be significant. The psychedelics industry itself is big enough to pique the interest of Big Pharma, with investment bank Canaccord Genuity, in a recent market report,estimating the total market size for all indications under investigation to be as much as $100 billion.

However, the smaller, more innovative players such as Revive, are likely toset the pace and make an impact.

Psychedelics have shown promising efficacy across a broad range of both mental and substance abuse disorders, said Canaccord inits report. Together, the targeted indications affect over one-billion people globally.

Frankstated:I think we have only scratched the surfacein a number of areas, and our team looks forward to educating the market more.

Contact the author Uttara Choudhury at[emailprotected]

Follow her onTwitter:@UttaraProactive

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Revive Therapeutics betting on psychedelics and potential COVID-19 treatment Bucillamine - Proactive Investors USA & Canada