Revive Therapeutics USA (RVVTF) CA (RVV) , which recently announced a $2.75 million acquisition of Psilocin Pharma Corp., a specialty psychedelic sciences company focused on the development of Psilocybin-based therapeutics for various medical needs.
Better still, Revive Therapeutics is investigating novel oral dosage forms of psilocybin, such as oral dissolvable thin films or tablets, based on the company’s wholly-owned patent-pending psilocybin formulations.
The US FDA and the Medical Community Supports Psychedelics
With the FDA’s more open-minded approach to psychedelic medicines, and as several major U.S. cities continue to approve the decriminalization of psilocybin, for example, investors are speculating that the psychedelic boom could be sizable.
Johns Hopkins Medicine launched the Center for Psychedelic and Consciousness Research to study compounds like LSD and psilocybin to treat a range of mental health problems, including anorexia, addiction and depression.
Psychiatrists at Johns Hopkins even found that mushrooms can help with smoking cessation. Another Johns Hopkins’ study found psilocybin can help with alcohol dependence, too.
Researchers from the University of California David found that micro-dosing with psychedelic drugs for a prolonged period of time showed promise.
A study in the journal, Nature — Psilocybin for treatment-resistant depression: fMRI-measured brain mechanisms – showed that 47% of treatment-resistant patients with depression showed positive responses five weeks after psilocybin treatments.
“Our study demonstrates that psychedelics can produce beneficial behavioral effects without drastically altering perception, which is a critical step towards producing viable medicines inspired by these compounds,” said David Olson of UC Davis, as quoted by Esquire.
Researchers at New York University found psilocybin mushrooms caused a “rapid and sustained” reduction in anxiety and depression in patients with cancer, as reported by the Financial Post. The list of findings goes on and on.
In fact, as the FDA and the medical community wake up to the opportunity, psychedelic growth could be out of this world, and revolutionize the way we treat mental and health issues.
Revive is a life sciences company focused on the research and development of therapeutics for infectious diseases and rare disorders, and it is prioritizing drug development efforts to take advantage of several regulatory incentives awarded by the FDA such as Orphan Drug, Fast Track, Breakthrough Therapy and Rare Pediatric Disease designations.
In addition, the company is exploring the use of Bucillamine for the potential treatment of infectious diseases, with an initial focus on severe influenza strains including COVID-19.
With the recent acquisition of Psilocin Pharma Corp., Revive is advancing the development of Psilocybin-based therapeutics in various diseases and disorders. Revive’s cannabinoid pharmaceutical portfolio focuses on rare inflammatory diseases and the company was granted FDA orphan drug status designation for the use of Cannabidiol (CBD) to treat autoimmune hepatitis and to treat ischemia and reperfusion injury from organ transplantation.
Acquisition of Psilocin Pharma Gives Revive a Strong Platform
In addition to Revive Therapeutics’ $2.75 million acquisition of Psilocin Pharma Corp., the company also has a partnership with the University of Wisconsin to advance its R&D initiatives of psilocybin-based formulations for the pharmaceutical sector.
“Revive has an intellectual property portfolio of psilocybin-based formulations ready to advance to the next stages of clinical development specifically with our relationship with the University of Wisconsin. The team there will bring a wealth of product formulation and testing experience with phytochemicals, including hallucinogenics,” said Michael Frank, Revive’s Chief Executive Officer.
Additionally, Revive Therapeutics will investigate novel oral dosage forms of psilocybin, such as oral dissolvable thin films or tablets, based on the company’s wholly-owned patent-pending psilocybin formulations and its exclusive licensed drug delivery technology from the Wisconsin Alumni Research Foundation (University of Wisconsin).
Revive also plans to finalize a sponsorship program around a Phase 1 clinical study examining psilocybin for the treatment of an undisclosed addiction use disorder. The clinical study will be conducted at the University of Wisconsin-Madison, School of Medicine and Public Health, and School of Pharmacy, which holds a Wisconsin special authorization and DEA license to perform clinical research with psilocybin.
However, there’s far more to Revive Therapeutics’ growth than psilocybin.
Revive Therapeutics is Preparing an IND for a Confirmatory Phase III clinical trial for COVID-19 Treatment
Revive Therapeutics is preparing an Investigational New Drug (IND) application for Phase III trials with Bucillamine for the treatment of infectious diseases like COVID-19.
In fact, the company just received positive feedback from the U.S. FDA, which recommended that Revive proceed directly into a Phase 3 confirmatory clinical trial to evaluate Bucillamine for the treatment of patients with mild-moderate COVID-19.
“FDA’s support in advising Revive to move directly into a Phase 3 confirmatory trial provides an acknowledgment for the potential of Bucillamine in the treatment of COVID-19,” added Michael Frank, CEO of Revive Therapeutics.”
“Entering into a Phase 3 study is a major milestone for the Company, and we are excited to unlock the full potential of Bucillamine not only for this virus but also for other infectious diseases that we will investigate in the future.”
Importantly, the FDA agreed that Revive could rely on its data included in its previous IND with Bucillamine for gout where it ran a Phase 2 FDA clinical study in the past to support the new COVID-19 Phase 3 initiative and, therefore, the Company did not have to perform any Phase 1 or Phase 2 clinical work.
The Company, along with its Contract Research Organization, Pharm-Olam, LLC, and its clinical development team led by Dr. Kelly McKee, Jr., MD, MPH, Chief Scientific Officer are actively incorporating the pre-IND meeting guidance and preparing the package for submission to the FDA. The Company expects to file the final IND this month and expects to initiate the Phase 3 study thereafter.
For one, Revive Therapeutics is quickly nearing Phase 3 trials for Bucillamine for the treatment of infectious diseases and the coronavirus disease (COVID-19) by submitting its Phase 3 IND this month.
Psilocin Pharma Corp. The company also engaged Complete Phytochemical Solutions to advance its R&D initiatives of psilocybin-based products for the pharmaceutical market, and it has a key relationship with Wisconsin Alumni Research Foundation(University of Wisconcin). Revive Therapeutics will investigate novel oral dosage forms of psilocybin, such as oral dissolvable thin films or tablets.
Three, the U.S. FDA and the medical community are supportive of psychedelics research. Plus, with the FDA being far more open-minded with psychedelic medicines, and with several major U.S. cities approving the decriminalization of psilocybin, the boom has only just begun.
Four, medical studies are finding that psychedelics can assist in the treatment of many health and mental issues impacting millions of people around the world.