Psychedelic treatments may soon revolutionize the way we treat the health and mental issues of millions of patients around the world.
Along the way, it could very well create a monster $5 billion a year opportunity.
“I have seen some investment groups out there who have invested $100 million in the last 12 to 24 months,” says Tim Regan, vice president of capital markets for KCSA Strategic Communications, as quoted by The Growth Op.
Granted, psychedelic drugs have been written off for years.
However, that may not be the case for much longer, especially with such drugs showing promise for treating a range of mental and health conditions, including obsessive-compulsive disorder, PTSD, opioid addiction, alcoholism, eating disorders, depression, and anxiety.
Even the medical community is well aware of the multi-billion-dollar opportunity
Johns Hopkins Medicine, for example 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 University even found that mushrooms can help with smoking cessation, and another study found it can assist with alcohol dependence.
Researchers from the University of California David found that micro-dosing with psychedelic drugs for a prolonged period of time showed promise. “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.
Revive Therapeutics (CSE:RVV)(OTC:RVVTF) for example announced a $2.75 million acquisition of Psilocin Pharma Corp., a specialty psychedelic sciences company focused on the development of Psilocybin-based therapeutics for significant unmet medical needs including rare and orphan indications.
The company also engaged Complete Phytochemical Solutions to advance its R&D initiatives of psilocybin-based products for the pharmaceutical market.
“Revive has an intellectual property portfolio of psilocybin-based formulations ready to advance to the next stages of clinical development and with our newly-established relationship with Complete Phytochemical Solutions they will bring a wealth of product formulation and testing experience with phytochemicals, including hallucinogenics. Complete Phytochemical Solutions will be instrumental in achieving milestones that will unlock the potential of our psilocybin-based platform,” said Michael Frank, Revive’s Chief Executive Officer.
In addition to Revive Therapeutics, other top companies to keep an eye on include Johnson & Johnson (NYSE:JNJ), Champignon Brands Inc. (OTC:SHRMF)(CSE:SHRM), Mind Medicine Inc. (OTC:MMEDF), and GW Pharmaceuticals (NASDAQ:GWPH).
Revive Therapeutics Ltd. (CSE:RVV)(OTC:RVVTF) BREAKING NEWS: Revive Therapeutics Ltd., provided further insight on its plans for its psilocybin-based pharmaceutical program. The Company 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.
“We are expanding our psilocybin-based pharmaceutical portfolio with unique oral dosage and drug delivery forms that will target and have the potential to treat diseases and disorders currently not investigated with psychedelic compounds,” said Michael Frank, Revive’s Chief Executive Officer. “We are combining our robust intellectual property portfolio in both psychedelic formulations and our drug delivery technology which is unique within the industry, and leveraging our research partnership with the University of Wisconsin-Madison to establish a specialty portfolio of psilocybin-based pharmaceuticals that we can advance to clinical trials and partnerships with other life sciences companies.”
Through initial evaluations with the Company’s research team, it has been found there are several unique parallels between the Company’s intellectual property portfolio of psilocybin-based formulations and delivery mechanism and the drug delivery technology, which is comprised of tannin-chitosan composites that have been studied with cannabidiol in the past.
Revive intends to research both delivery mechanisms in parallel as each provides its own unique qualities such as the potential of rapid onset of action and time-release compositions. The future of psilocybin as a medication will come in many forms. The Company believes that the most optimal delivery method to pursue and unlock the potential of psilocybin to treat a broad spectrum of diseases and disorders will be in the form of both an oral dissolvable tablet and an oral thin film strip, commonly recognized as a ‘Breath Strip’. The Company is preparing its formulation development plans intending to pursue clinical studies for indications currently not being evaluated with psilocybin. We believe the combination of psilocybin and our tannin-chitosan delivery platform gives us a unique advantage.
Revive’s psilocybin-based formulations have been engineered to work synergistically with the body’s own natural pathways of absorption while offering a contemporary approach to consumption. The Company has key provisional patent applications with the U.S. Patent and Trademark Office that cover methods of production of psilocybin-based formulations, including sublingual sprays, effervescent tablets, hard-shell capsules, sublingual and transmucosal delivery systems (i.e. gum drops, oral strips, dosing pens). Furthermore, Revive has a patent-pending portfolio that includes Psilocybin extraction and crystallization methodologies.
The drug delivery technology aims to deliver both synthetic and natural extract of psilocybin in a potential number of ways such as topical gels, creams or ointments, oral or transdermal patches, oral dosages and foams. The delivery technology is a natural, non-toxic, biodegradable and biocompatible composite that combines a tannin material, which is derived from a plant group having antibacterial, antifungal, antioxidant and wound healing properties, and a chitosan material, which is derived from the crustacean group having blood-clotting and antimicrobial properties. The delivery technology has a rapid onset of action and controlled or sustained release potential capabilities and may allow combining multiple extracts from mushrooms in one formulation.
In addition, Revive Therapeutics is preparing an Investigational New Drug (IND) application for Phase 3 trials with Bucillamine.
Revive Therapeutics received positive feedback from the U.S. Food and Drug Administration in response to the Company’s Pre-Investigational 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-moderate COVID-19 due to the SARS-CoV-2 infection in order to ensure expeditious evaluation of the safety and efficacy of Bucillamine.
“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,” said Michael Frank, Chief Executive Officer of Revive. "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.”
In addition to its recommendation, the FDA provided valuable guidance on study design and outcome measures for the Phase 3 study. Importantly, the FDA agreed that Revive could rely on its data included in its previous IND with Bucillamine for gout to support the COVID-19 Phase 3 study and, therefore, the Company did not have to perform any Phase 1 or Phase 2 clinical studies. 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 consultant and Dr. Onesmo Mpanju, PhD, Regulatory Affairs consultant, 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 within the next 60 days and will plan to initiate the Phase 3 study thereafter.
Other related developments from around the markets include:
Johnson & Johnson (NYSE:JNJ) announced that its Janssen Pharmaceutical Companies received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for its investigational Ebola vaccine regimen for the prevention of the Ebola Virus Disease caused by the Zaire ebolavirus species. Two Marketing Authorization Applications (MAAs) were submitted to the EMA in support of the vaccines in the two-dose regimen (Ad26.ZEBOV, MVA-BN-Filo). Janssen’s investigational Ebola vaccine regimen is specifically designed to support preventive vaccination in countries that are at risk of Ebola outbreaks, as well as for other at-risk groups such as healthcare workers, Biosafety Level 4 (BSL-4) lab workers, military deployed from other countries, airport staff and visitors to high-risk countries. Janssen is collaborating with the World Health Organization (WHO) on vaccine pre-qualification to broaden access of its investigational Ebola vaccine regimen to those most in need and enable registration in African countries; European Commission (EC) approval of this regimen may help accelerate this process. The most recent Ebola outbreak, which started in the Democratic Republic of the Congo (DRC) in 2018 was the world’s second worst on record. It has caused more than 3,000 cases and over 2,000 deaths – a mortality rate of 65 percent.
Champignon Brands Inc. (OTC:SHRMF)(CSE:SHRM), a human optimization sciences Company with an emphasis on ketamine and psychedelic medicine, is pleased to sponsor TheraPsil, a BC-based non-profit coalition of healthcare professionals, policy-makers and community leaders seeking legal access to psilocybin for British Columbians with a palliative diagnosis and psychological distress. Operating at highest standards of clinical competence and ethical integrity, the TheraPsil coalition is starting in 2020 with seeking legal access to psilocybin for British Columbians with a palliative diagnosis and psychological distress. Based in Victoria, British Columbia and established in 2019, TheraPsil is focused on Compassionate Access: Establishing safe, and legal access to psychedelic-assisted therapy for those in medical need; Public Education: Increasing awareness of the merits and limitations of psychedelic-assisted therapy; Professional Training; Developing safe, simple and effective protocols for credentialed health professionals to deliver psilocybin-assisted therapy, in collaboration with other active organizations; and, Research: Facilitate research and evaluation in collaboration with Canadian and international partners.
Mind Medicine Inc. (OTC:MMEDF), the leading neuro-pharmaceutical company for psychedelic inspired medicines, is now adding the psychedelic compound MDMA to its R&D pipeline. The latest development comes as part of MindMed's exclusive license and collaboration agreement with the University Hospital Basel's Liechti Lab. The company will now gain access to a compelling portfolio of clinical trials and studies gathered by the Liechti Lab over a 10 year period on MDMA. "We have generated a large amount of data on the pharmacokinetics, pharmacogenetics and safety of MDMA in over 10 years of clinical research," said University of Basel Department of Biomedicine Professor Dr. Matthias Liechti. "Our lab in collaboration with MindMed will also explore the benefits of MDMA and related substances when used alone or when combined with other psychedelics to treat mental health disorders."
GW Pharmaceuticals (NASDAQ:GWPH), a world leader in the science, development, and commercialization of cannabinoid prescription medicines, announced financial results for the first quarter ended March 31, 2020. “In the first quarter of 2020, we have seen continued strength of the Epidiolex brand in both the U.S. and Europe and remain confident about prospects for growth in the remainder of the year. Having been granted priority review by the FDA for our proposed label expansion to include TSC, our US commercial team is actively preparing for the launch of this indication in August,” stated Justin Gover, GW’s CEO. “In this current environment caused by COVID-19, we have been able to support the epilepsy community remotely and maintain production of Epidiolex, while taking necessary steps to maintain the wellbeing of our employees. Looking ahead, GW is well placed to emerge strongly from the COVID-19 crisis with significant growth prospects for Epidiolex in the US and Europe, important pipeline clinical trials ready to execute, a strong balance sheet, and an unparalleled leading position in cannabinoid science.”
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