Revive Therapeutics Ltd (CSE: RVV) (OTCMKTS: RVVTF) is a life sciences company focused on the research and development of therapeutics for rare disorders and infectious diseases.  Revive’s cannabinoid pharmaceutical portfolio focuses on rare inflammatory diseases and was granted FDA orphan drug status designation for the use of CBD to treat auto-immune hepatitis (liver disease) and the use of CBD to treat ischemia and reperfusion injury from organ transplantation. Through its subsidiary Psilocin Pharma Corp., the Company advances Psilocybin-based therapeutics in various diseases and disorders and will prioritize 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. 

As a result of its sponsored research partnership agreement entered into with the Reed Research Group out of the University of Wisconsin-Madison to evaluate novel formulations of psilocybin, the Company received its first set of orally dissolvable thin film strips initially to be used to deliver psilocybin and subsequently additional psychedelic-derived medicines. 

Revive Therapeutics has identified tannin-chitosan composite of orally dissolvable thin films as the lead candidate for the development of a unique delivery platform for therapeutic doses (1-20mg) of psilocybin into the oral cavity. Revive Therapeutics believes that there are a number of advantages and benefits of an orally dissolvable psilocybin thin film such as the rapid dissolving and onset of action. The orally dissolvable thin film prototypes will undergo further scientific testing through a broad range of studies. The drug delivery technology aims to deliver both synthetic and natural extract of psilocybin in a potential number of ways such as orally dissolvable thin films, 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. 

Revive Therapeutics entered into a clinical trial agreement with the Board of Regents of the University of Wisconsin System to conduct a clinical study entitled, “Phase I Study of the Safety and Feasibility of Psilocybin in Adults with Methamphetamine Use Disorder.” Under the terms of the CTA, Revive has an exclusive option to obtain an exclusive, worldwide, royalty-bearing commercialization license to all rights, title and interest that UWS may have or obtain in any invention that results from the clinical study. Currently there are around 1.1 million people in the US addicted to meth.  

Revive Therapeutics has been busy recently: 

(i) signed a supply agreement with Havn Life Sciences Inc. to source naturally derived psychedelic compounds, such as psilocybin, for use in future investigational new drug enabling studies andclinical trials under the FDA guidelines; 

(ii) entered into an exclusive research collaboration agreement with PharmaTher Inc. (“PharmaTher”), a wholly owned subsidiary of Newscope Capital Corporation, to accelerate the development of psilocybin in the treatment of cancer and the discovery of novel uses of undisclosed psychedelic compounds including stroke and traumatic brain injury applications; 

(iii) entered into an asset purchase agreement with PharmaTher to acquire the full rights to PharmaTher’s intellectual property pertaining to psilocybin; 

(iv) entered into an agreement with the University of Health Sciences Antigua (“UHSA”) to collaborate on utilizing Revive’s novel psychedelic-assisted therapies and pioneering the clinical research and development of psychedelics in Antigua and Barbuda; 

(v) entered into a sponsored research agreement and an exclusive option to license agreement with North Carolina State University (“NC State”) 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; and 

(vi) entered into a feasibility agreement with LTS Lohmann Therapie-Systeme AG (“LTS”), a leader in pharmaceutical oral thin films, to develop and manufacture a proprietary oral psilocybin thin film strip for the Company’s clinical and commercial initiatives to evaluate in mental illness, neurological and substance abuse disorders. 

(vii) Entered into a research collaboration agreement with PharmaTher Inc. to evaluate the delivery of psilocybin with PharmaTher’s proprietary microneedle patch technology for neuropsychiatric fisorders. 

$rvv $rvvtf #bucillamine does not want to comprise study, I like one of their goals:-
Secure alliances with strategic partners, including pharmaceutical companies, to achieve Bucillamine’s full commercial potential—>open for business https://t.co/K1EU21Air0

— mactwo (@mactwo2013) March 20, 2023

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Revive Therapeutics is also engaged in evaluating the use of cannabidiol in the treatment of autoimmune hepatitis (“AIH”) and in the prevention of ischemia/reperfusion injury resulting from solid organ transplantation. The Company was granted orphan drug designation for cannabidiol in the treatment of autoimmune hepatitis by the FDA. The Company entered into a clinical trial agreement with The Trustees of Indiana University (“TIU”) to develop and manage a clinical study entitled, “Use of Cannabidiol as an adjunct therapy for difficult to treat autoimmune hepatitis.” TIU and the Company are in the process of completing the protocol and study documents for submission with the FDA. 

In addition to developing bucillamine for infectious diseases and rare disorders, Revive is building a specialty psychedelics program, which includes psilocybin and MDMA to treat mental health and abuse disorders. The Company’s psilocybin programs include: 

• evaluating psilocybin in a Phase 1/2 clinical study for methamphetamine use disorder via a research collaboration with the University of Wisconsin-Madison. 
• developing a novel psilocybin oral thin film strip through a feasibility agreement with LTS Lohmann Therapie-Systeme AG, a leader in pharmaceutical oral thin films. 
• developing a novel biosynthetic version of psilocybin based on a natural biosynthesis enzymatic platform under its research collaboration with North Carolina State University. 

Revive is led by CEO Derrick Welsh who brings 14 years of Health Care experience, with the past 5 years in the Cannabis industry. Derrick has worked with several high profile publicly traded Cannabis companies like Xanthic Bio Pharma and Green Growth Brands. During this time, he developed several patent pending formulations. The formulations he developed are for water Soluble THC and CBD products such as beverages, water enhancers and effervescent tablets.  He has developed quality systems, standard operating procedures and method validation for production of these products. Leveraging his previous experience with cannabinoids Derrick found opportunity in the upcoming psychedelics marketspace. 

Revice hit new lows on Monday after the Company announced an update from the 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. On March 8th, 2023, the Company received the Type C meeting written responses from the FDA to obtain agreement on the proposed protocol endpoints for the Company’s Study. The FDA recommended that the Company’s proposed primary symptom-based endpoint should cover the evaluation of time to sustained recovery assessed over an appropriate duration, evidence of subjects experiencing resolution of COVID-19 related symptoms and the element of sustained symptom resolution. 

After a further in-depth review and analysis of the FDA recommendations with members of the Company’s clinical trial team, including its statistician, regulatory affairs, medical affairs, and clinical research advisors, the Company has decided that in the best interest of the Study to preserve and not compromise the integrity of the Study and keep the blinded data intact to support a potential FDA approval in the future. As a result, the Company is committed to advancing the clinical and commercial development of Bucillamine and plans to pursue the following activities: 

• Continue discussions with the FDA on a pathway for future potential regulatory approval under the current Study’s objectives, which the FDA and DSMB continue to support; 
• Work with the Study’s current participating clinical sites and potential new clinical sites to develop a defined recruitment plan that prioritizes subjects recognized to be at higher risk for developing severe COVID-19 to achieve the Study’s objectives; 
• Determine potential opportunities of unblinding additional data related to the Study for evaluation to support future discussions with the FDA, and further studies for Long COVID or COVID symptom-related conditions, which the FDA provided advice to pursue, and various infectious and respiratory disorders; 
• Develop reformulation strategies of Bucillamine to expand on its potential therapeutic utility targeting rare disorders that may come with regulatory incentives awarded by the FDA, such as orphan drug (i.e. ischemia-reperfusion injury, cystinuria), fast track, and breakthrough therapy designations; and 
• Secure alliances with strategic partners, including pharmaceutical companies, to achieve Bucillamine’s full commercial potential. 

Revive Therapeutics Provides Update of Phase 3 Clinical Study for Bucillamine in the Treatment of COVID-19 $RVV $RVVTFhttps://t.co/lTCbNvAhxP

— jungle.java (@junglejava1) March 20, 2023

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Currently trading at a $22 million market valuation Revive Therapeutics os is 320,008,751 with 315,580,417 shares in the public float. The Company’s books are ok with $700k in the treasury and $4 million in liabilities. Revive Therapeutics is an exciting biotech trading both in Canada and the US that just reversed off 52-week lows after the FDA adjusted the endpoints of its Phase 3 Clinical Study for Bucillamine in the Treatment of COVID-19. The Company is still committed to advancing the clinical and commercial development of Bucillamine and decided that in the best interest of the Study to preserve and not compromise the integrity of the Study and keep the blinded data intact to support a potential FDA approval in the future. Revive has a lot going on besides this; the Company was granted orphan drug designation for cannabidiol in the treatment of autoimmune hepatitis by the FDA and has entered into a clinical trial agreement with The Trustees of Indiana University to develop and manage a clinical study entitled, “Use of Cannabidiol as an adjunct therapy for difficult to treat autoimmune hepatitis. Revive Therapeutics made a legendary run up the charts during 2020 culminating in a run to over $0.70 per share in the US. We will be updating on Revive Therapeutics when more details emerge so make sure you are subscribed to newsytrends.com by entering your email below.

Disclosure: we hold no position in Revive Therapeutics either long or short and we have not been compensated for this article.