Revive Therapeutics Ltd (CSE:RVV) (OTCMKTS:RVVTF) has come a long way in just six months under the stewardship of CEO Michael 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-19 possible treatment headed towards 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.
Revive has a history of repurposing drugs and IP such as Bucillamine, a cysteine derivative anti-inflammatory that has been used for more than 30 years to treat rheumatoid arthritis in Japan and South Korea.
With an impeccable track record for safety, the company’s researchers were assessing the data from its potential deployment in acute gout flares where it had successfully completed a phase II US Food and Drug Administration (FDA) clinical trial.
That’s 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. Revive’s 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-19 and was surprised by the response.
Based on Bucillamine’s composition, efficacy, safety and history, as well as a previous, successful interaction with the FDA, the drugs watchdog asked Revive to prepare an Investigational New Drug (IND) submission for a phase III confirmatory trial in COVID-19.
“That’s 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 into its IND package, which should be ready and submitted by the end of the month, Frank adds.
Exciting move into psychedelics
Another development that is exciting investors is the company’s move into psychedelics, which appears incredibly well-timed.
Last year the FDA approved esketamine 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 announced it was acquiring Psilocin Pharma Corp in an all-paper deal worth $2.75 million. Its focus is psilocybin-based treatments for various medical needs, which includes rare and orphan indications.
Revive is 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 that’s 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 to set the pace and make an impact.
“Psychedelics have shown promising efficacy across a broad range of both mental and substance abuse disorders,” said Canaccord in its report. “Together, the targeted indications affect over one-billion people globally.”
Frank stated: “I think we have only scratched the surface in a number of areas, and our team looks forward to educating the market more.”