“Let them say what they want, we know what we’re doing, and we’re doing the work,” Michael Frank told me a month ago, as he put out news claiming his little pharma company, which had built a reputation for chasing aggressively into new pharmaceutical fields, had found some IP that might be useful in the fight against what is, among other things, the most financially devastating crisis the world has seen.
Revive Therapeutics Ltd. is exploring the use of the drug Bucillamine as a potential novel treatment for infectious diseases including influenza and the coronavirus disease (Covid-19). The company has applied for a provisional patent with the U.S. Patent and Trademark Office entitled “Use of Bucillamine in the Treatment of Infectious Diseases” (serial No. 62/991,996).
The market snickered. Revive had only recently stepped into the psyilicibin world, which many had reasoned was bullshit and pumpy dumpy, and had got there through an earlier push through cannabis-based pharma, which had in turn followed a focus on plain old vanilla pharma.
Revive was a chaser, the form guide said, and it hadn’t managed to knock out a home run yet.
“And the guys, they’re deal guys!” others said. “Got in cheap! Will be out first!”
Sure. Maybe. You’ll want to factor that in, as you’ll do with any CSE-based deal.
‘But what if they actually have something?’, I wondered publicly. ‘What would it look like if Revive wasn’t a pump, if it actually had something that could make a difference? How would we know? What signs would we see? What does real FDA work look like?’
This isn’t the first time that the company has explored uses for that of Bucillamine, which has been used for over thirty years in South Korea and Japan to combat rheumatoid arthritis. The company has previously gone as far as conducting a Phase 2 study on the use of the drug for the purposes of treating acute gout flares, which was accepted by the FDA under an investigational new drug (IND) application. Revive also previously explored the use of the drug for cystinuria for which it received orphan drug status.
FDA approval of any drug, or even a label change to an existing drug, is a LONG process. More so, it’s a complicated one, where a knucklehead company that didn’t know what it was doing could stumble every few feet. You need smart academics attached. You need consultants who navigate this process for a living. You need paperwork by the metric ton and, frankly, you need the FDA to want your success.
Right now, anything with a potential COVID-19 use is being accelerated through the system ahead of the next Pfizer headache pill or college-backed back pain study. A treatment for, or vaccine to prevent, COVID-19 could literally save economies trillions of dollars so, yeah, bring your IP, Michael Frank.
So has Revive done the work?
First, they got bodies in the room.
Dr. David Boulware, MD, MPH, CTropMed, FIDSA, will join Revive Therapeutics Ltd. as a scientific adviser to guide the company’s current and future clinical programs, including its research and development strategy for infectious diseases, including COVID-19. Dr. Boulware is an infectious disease physician-scientist and professor of medicine, division of infectious diseases and international medicine, at the University of Minnesota. Dr. Boulware is currently the principal investigator of a globally recognized COVID-19 clinical trial to determine if postexposure prophylaxis with hydroxychloroquine can prevent progression development of symptomatic COVID-19 disease after known exposure to the SARS-CoV-2 virus.
Real work: Check.
Then they got their US consultants:
Revive Therapeutics Ltd. has retained Pharm-Olam LLC, with proven clinical experience in infectious diseases completing over 100 clinical studies in approximately 19,000 patients at over 2,000 clinical sites, to serve as the company’s contract research organization (CRO) to advance the future clinical study for Bucillamine in the treatment of infectious diseases, including the coronavirus disease (COVID-19).
Real work: Check.
Then they got busy in Asia, which has an earlier path to approval than the US.
Revive Therapeutics Ltd. has retained Novotech to serve as the company’s clinical research organization (CRO) to pursue future human clinical studies for bucillamine in the treatment of infectious diseases, including COVID-19 in Asia-Pacific countries.
Real work: Check.
For a pump and dump, this outfit is sure looking like it’s performing actual work.
The proof, however, is not in the partnerships and plans, but in the results.
To that end, Revive had planned to get approval with the FDA to run phase 2 clinical trials.
The company is finalizing its regulatory package and clinical study plan for Bucillamine in the treatment of COVID-19 and it will submit for regulatory approval, by way of an IND application submission to the U.S. FDA, to investigate Bucillamine in a proposed phase 2 clinical study.
But the FDA had other ideas and has instead PUSHED THEM STRAIGHT TO PHASE 3.
REVIVE THERAPEUTICS ANNOUNCES U.S. FDA RECOMMENDATION TO PROCEED DIRECTLY INTO A PHASE 3 CONFIRMATORY CLINICAL TRIAL
Revive Therapeutics Ltd. has received positive feedback from the U.S. Food and Drug Administration in response to the company’s preinvestigational new drug meeting that was announced on April 3, 2020. The FDA recommended that the company proceed directly into a phase 3 confirmatory clinical trial to evaluate Bucillamine for the treatment of patients with mild to moderate COVID-19 due to the SARS-CoV-2 infection in order to ensure expeditious evaluation of the safety and efficacy of Bucillamine.
Straight to phase 3, motherfuckers!
This is a big deal. Generally speaking, to get to phase 3 trials for any pharma company requires millions of dollars, a lot of time, and a lot of luck. Revive got there a month after announcing it was hoping for phase 2 and raising $1.7 million.
And, yeah, they’re still looking at the shrooms, which I am absolutely there for.
When we started telling you about RVV, it was a $0.05 stock. It’s $0.19 today. Still cheap IMO, especially if they keep this roll going.
— Chris Parry
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