Debra BorchardtFebruary 6, 2023
PharmaAla to supply the MDMA.
Revive Therapeutics Archives - Green Market Report
Debra BorchardtFebruary 6, 2023
Adam JacksonSeptember 16, 2022
Oral psilocybin film-strips to treat could conduct the first-in-human clinical study as soon as next year.
StaffJune 27, 2022
Revive Therapeutics Ltd. (OTCQB: RVVTF) (CSE: RVV) gave an update last week on the company’s U.S. Food & Drug Administration (FDA) Phase 3 clinical trial (NCT04504734) to evaluate the safety and efficacy of Bucillamine, an oral drug with anti-inflammatory and antiviral properties, in patients with mild to moderate COVID-19.
Following Revive receiving positive comments from the FDA in regards to the company’s request to determine and agree on the Study’s potential new primary efficacy endpoints and the company’s submission of a Data Access Plan (“DAP”) to the FDA, the FDA has accepted the DAP to allow for the unblinding of the pre-dose selection data. The company will now proceed to unblind the pre-dose selection data to potentially support the amended Study protocol with the new primary efficacy endpoints. The proposed new primary efficacy endpoints may include the rate of sustained clinical resolution of symptoms of COVID-19, which addresses the shift in COVID-19 clinical outcome observed over the course of the pandemic, and, therefore, to have more meaningful study endpoints for the FDA to consider for potential Emergency Use Authorization.
Despite the pandemic seemingly waning, the company believes that with the Omicron variant, including the BA.2 variant, being the dominant strain over the Delta variant, there is an urgent need to treat symptom resolutions in addition to preventing hospitalizations. Revive made sure to note that it is not making any express or implied claims that its product has the ability to eliminate or cure COVID-19 (SARS-2 Coronavirus) at this time.
Medical Mushrooms
According to a study, medicinal mushrooms have documented effects on different diseases, including infections and inflammatory disorders. “The related Basidiomycota Agaricus blazei Murill (AbM), Hericium erinaceus (HE), and Grifola frondosa (GF) have been shown to exert antimicrobial activity against viral agents, Gram‐positive and Gram‐negative bacteria, and parasites in vitro and in vivo. Since the mechanism is immunomodulatory and not antibiotical, the mushrooms should be active against multi‐drug resistant microbes as well. Moreover, since these Basidiomycota also have anti‐inflammatory properties, they may be suited for the treatment of the severe lung inflammation that often follows COVID‐19 infection.”
“An AbM‐based mushroom extract (Andosan), also containing HE and GF, has been shown to significantly reduce bacteraemia and increase survival in mice with pneumococcal sepsis, and to improve symptoms and quality of life in IBD patients via an anti‐inflammatory effect. Hence, such mushroom extracts could have prophylactic or therapeutic effect against the pneumonic superinfection and severe lung inflammation that often complicates COVID‐19 infection. Here, we review antimicrobial and anti‐inflammatory properties of AbM, HE and GF mushrooms, which could be used for the battle against COVID‐19.”
The Center for East-West Medicine, at the University of California Los Angeles (UCLA) applied to the US Food and Drug Administration (FDA) in April 2020 for approval to conduct 2 randomized phase 1 trials. According to the JAMA Network, the double-blind, placebo-controlled studies would evaluate the safety and feasibility of treating mild to moderate COVID-19 with either medicinal mushrooms, which have a long history as natural therapeutics for pulmonary disease, or a Chinese herb formulation that’s widely used there as a COVID-19 remedy. JAMA reported that the FDA ultimately sanctioned the MACH-19 (Mushrooms and Chinese Herbs for COVID-19) trials, which are now underway at UCLA and UCSD and are supported by the Krupp Endowed Fund. Meanwhile, a third MACH-19 trial is investigating the use of medicinal mushrooms as an adjuvant to COVID-19 vaccines.
“Researchers are currently conducting in vitro and animal studies with natural products to evaluate direct antiviral activity or to address COVID-19 sequelae,” D. Craig Hopp, PhD, deputy director of the Division of Extramural Research at the National Center for Complementary and Integrative Health (NCCIH), said in an interview. But the MACH-19 treatment trials are unique, he noted, because they’re evaluating natural products among humans with acute SARS-CoV-2 infection.”
Dave HodesMay 31, 2022
The shuffling of psychedelics companies into and out of success as shown in their respective quarterly earnings and annual reports over the last few weeks offers a glimpse into what it takes to survive and thrive in the industry.
The strategic acquisition, development of novel therapeutics, and building awareness and collaborations are the names of the game today in what is still an emerging industry rife with challenges and opportunities.
Here’s a look at three such companies and their strategies:
- Delic Corp. (CSE: DELC) (OTCQB: DELCF) which bills itself as a “leader in new medicines and treatments for a modern world,” acquired Ketamine Wellness Centers LLC in November which owns and operates 10 ketamine infusion treatment clinics across Arizona, Colorado, Florida, Illinois, Minnesota, Nevada, Texas, Utah, and Washington. Ketamine infusions have emerged as a promising treatment option for chronic diseases and pain disorders. This $10 million acquisition makes the company the owner of the largest chain of wellness centers providing ketamine treatments in the U.S., and is a leading company building the psychedelics industry’s infrastructure.
Ace in the hole? Matt Stang, co-founder and CEO of Delic since January 29, 2021, was an owner and operator of High Times magazine for 17 years. Stang helped legalize cannabis in multiple states, and launched High Times’ most popular event, the Cannabis Cup, in the U.S. Stang is considered one of the most connected people in the alternative drug space.
- Revive Therapeutics LTD. (OTCQB: RVVTF) (CSE: RVV), a specialty life sciences company focused on the research and development of therapeutics for medical needs and rare disorders, is building a specialty psilocybin-based product pipeline to treat mental illness, substance abuse and neurological disorders. They are launching their first clinical study evaluating psilocybin in the treatment of methamphetamine use disorder, and advancing the development of an oral psilocybin thin file strip and psilocybin microneedle patch.
Ace in the hole? The company is studying psilocybin as a potential treatment for stroke with the University of Wisconsin-Madison. It is one of the first companies to explore the role that psychedelics may play in the treatment of brain injury, with implications for treating Parkinson’s and other neurodegenerative diseases.
- Wellbeing Digital Sciences (NEO: MEDI) (OTC: KONEF) is an evidence-based healthcare company focused on innovative clinical solutions, artificial intelligence-powered digital therapeutics and contract research. One of its subsidiaries, KGK Science Inc., was selected by Lophos Pharmaceuticals Inc. for a novel study to evaluate a path to market for peyote-derived natural health products, one of just a handful of companies pursuing development of peyote for medicinal use. Wellbeing is also developing a study of patients with post-traumatic stress disorder who are undergoing the proprietary physical therapy program through another subsidiary, IRP Health.
Ace in the hole? Led by new Wellbeing CEO Najla Guthrie, the former chief medical officer of the company, who is also the president and CEO of KGK Science, the company became the founding sponsor of Women in Psychedelics Network (WIP) in May. WIP was created to bring women together in the psychedelic industry, of every discipline, and build a community based on education, support, growth, and experience as more women rise to the top of the psychedelics industry. One top woman in psychedelics Dr. Ekaterina Malievskaia, is the co-founder and chief innovation officer for Compass Pathways
StaffJanuary 21, 2021
No sooner had Revive Therapeutics Ltd. (OTC: RVVTF) announce it had raised $10, then it stopped trading to say the deal was upsized to $20 million. Revive is a specialty life sciences company focused on the research and development of therapeutics for medical needs and rare disorders. The company entered into an agreement with Canaccord Genuity Corp. and Leede Jones Gable Inc. to pay $0.50 per Equity Unit. Under the amended terms, the Underwriters have agreed to purchase, on a bought deal basis, 40 million Equity Units for gross proceeds to the Company of $20 million. The stock was lately selling at $0.47. The closing of the offering is expected to occur on or about the week of February 8, 2021.
The company said that the net proceeds would be used for Phase 3 clinical costs for Bucillamine for COVID-19, Phase 1 clinical costs for Psilocybin for methamphetamine use disorder study, and other Psychedelic formulation development work as well as working capital and general corporate purposes.
Revive has also granted the Underwriters an over-allotment option at any time until 30 days following the Closing, to purchase up to that number of additional Equity Units, Common Shares or Warrants, or any combination thereof, as is equal to 15% of the aggregate number of Equity Units sold in the Offering to cover over-allotments, if any.
The company announced last week that it had entered into a sponsored research agreement and an exclusive option to license agreement with North Carolina State University to develop a novel biosynthetic version of psilocybin based on a natural biosynthesis enzymatic platform developed by Dr. Gavin Williams, Professor and Researcher at NC State. The biosynthetic platform developed by Dr. Gavin Williams will provide a potentially simple and efficient method for rapidly producing natural products, such as psilocybin, using an engineered enzymatic pathway in E. coli.
Revive seeks to develop and commercialize its own pharmaceutical-grade psilocybin with this biosynthesis technology at scale to support the Company’s current psilocybin-based product pipeline that includes an oral thin film product currently being developed in collaboration with the University of Wisconsin-Madison and the intellectual property and research with psilocybin being developed by PharmaTher Inc. (CSE: PHRM, OTCQB: PHRRF). The company also recently acquired Psilocin Pharma Corp. and 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 (liver disease) and to treat ischemia and reperfusion injury from organ transplantation
Terms
Each Equity Unit will consist of one (1) common share of the Company (a “Common Share“) and one (1) Common Share purchase warrant (a “Warrant“). Each Warrant will entitle the holder thereof to purchase one Common Share at an exercise price of $0.70 (the “Exercise Price“) at any time up to thirty-six (36) months following Closing (as defined below). The expiry of the Warrants may be accelerated by the Company at any time prior to the expiry date of the Warrants if the volume-weighted average price of the Common Shares on the Canadian Securities Exchange (the “Exchange“) is greater than $1.10 for any ten (10) consecutive trading days, at which time the Company may, within ten (10) business days, accelerate the expiry date of the Warrants by issuing a press release announcing the reduced warrant term whereupon the Warrants will expire on the 30th calendar day after the date of such press release.
Debra BorchardtApril 29, 2020
Specialty life science company Revive Therapeutics Ltd. (CSE: RVV) has said that it will investigate novel oral dosage forms of psilocybin, such as oral dissolvable thin films or tablets, based on its 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.”
The company said in a statement that through initial evaluations with its research team, it has 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 said it 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.
New Interest in Psilocybin
Psilocybin is being viewed as a treatment for several conditions including drug-resistant depression. Studies have been performed to illustrate the efficacy of psilocybin for this specific purpose. One completed study found that psilocybin produced substantial and sustained decreases in depression and anxiety in patients with life-threatening cancer. The study was published in 2016, and wrote that “At 6-month follow-up, these changes were sustained, with about 80% of participants continuing to show clinically significant decreases in depressed mood and anxiety. Participants attributed improvements in attitudes about life/self, mood, relationships, and spirituality to the high-dose experience, with >80% endorsing moderately or greater increased well-being/life satisfaction.”
According to the World Health Organization, almost 350 million people worldwide were affected by depression in 2016. Common antidepressant drugs help maintain the balance of various hormones and chemicals in the brain, which assists in the treatment of depression.
The Center for Disease Control and Prevention (CDC), reported that the percentage of people above the age of 12 years using antidepressants in the U.S. rose to 12.7% in 2011-2014. According to MedGadget, the antidepressant drug market was valued at $13.69 billion in 2018 and is expected to reach $15.88 billion by 2025. The CDC said that in the U.S., antidepressants were the most commonly prescribed drugs in 2013 and from over 16 million long term users, around 70% are female.
Psilocin Acquisition
In March, Revive completed its 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. Psilocin developed patent-pending formulation and production solutions for the active compound Psilocybin. The process encompassed with its intellectual property cover methods of production of Psilocybin-based formulations.
In a statement, the company noted that Psilocin has also developed formulations to date which include the Hydroxy Line. The line will include PSY-0.1 -Capsules- PSY-0.2 -Sublingual Spray- PSY-0.3 -Gel Cap- PSY-0.4/0.5 -Effervescent Tablets-and PSY-0.6 -Breath Strips. The precisely dosed formulations will work with both natural and synthetically derived Psilocybin which will be targeted for clinical research and subject to U.S. Food and Drug Administration (“FDA”) approval in the treatment of depression, anxiety, bi-polar disorder, bulimia and anorexia nervosa, and a number of other diseases. Psilocin’s range of products have been engineered to work synergistically with the body’s own natural pathways of absorption while offering a contemporary approach to consumption
Best Delivery Method
Revive believes that the most optimal delivery method to deliver psilocybin 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 said that it is preparing its formulation development plans to pursue clinical studies for indications currently not being evaluated with psilocybin.
The company reported that it 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). In addition to those patent applications, Revive has a patent-pending portfolio that includes Psilocybin extraction and crystallization methodologies.
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.
Revive is also exploring the use of Bucillamine for the potential treatment of infectious diseases, with an initial focus on severe influenza strains including COVID-19.
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