Revive Therapeutics Clarifies Status of Its Phase 3 Clinical Trial for Bucillamine in COVID-19
Revive Therapeutics Ltd. (OTCQB: RVVTF) is advancing its Phase 3 clinical trial for Bucillamine, targeting patients with mild to moderate COVID-19. Approximately 700 subjects have enrolled, with plans to expand into Turkey by mid-February 2022. The study aims to assess Bucillamine's safety and efficacy, emphasizing that no claims are made regarding its ability to cure COVID-19. The enrollment completion is anticipated by Q1 2022. The company is leveraging FDA regulatory incentives for its drug development efforts, including Orphan Drug and Fast Track designations.
- 700 subjects enrolled in Phase 3 clinical trial for Bucillamine.
- Expansion into Turkey planned by mid-February 2022.
- Anticipated completion of enrollment in Q1 2022.
- None.
- Approximately 700 subjects participated in the enrollment period
- Expected to begin subject enrollment in Turkey by mid-February
- Expected to complete enrollment in Q1-2022
TORONTO, Jan. 06, 2022 (GLOBE NEWSWIRE) -- Revive Therapeutics Ltd. (“Revive” or the “Company”) (OTCQB: RVVTF) (CSE: RVV) (FRANKFURT: 31R), a specialty life sciences company focused on the research and development of therapeutics for medical needs and rare disorders, wishes to clarify certain disclosures in its press release titled “Revive Therapeutics Provides Update on Phase 3 Clinical Trial for Bucillamine in COVID-19,” issued on December 29, 2021 that provided an update on the Company’s U.S. Food & Drug Administration (“FDA”) Phase 3 clinical trial (the “Study”) (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.
As of December 29, 2021, there were approximately 700 subjects that participated in the enrollment period of the Study. In addition, the Company has begun the process to expand the Study’s patient population in Turkey in collaboration with Delta Health, which will add research sites from the largest hospital group in Turkey, MLP Care and Istinye University.
The Company expects patient enrollment in Turkey to occur by mid-February and completion of the Study’s enrollment in Q1-2022.
The Company 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.
About Revive Therapeutics Ltd.
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. Currently, the Company is exploring the use of Bucillamine for the potential treatment of infectious diseases, with an initial focus on severe influenza and COVID-19. With its 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 (liver disease) and to treat ischemia and reperfusion injury from organ transplantation. For more information, visit www.ReviveThera.com.
For more information, please contact:
Michael Frank
Chief Executive Officer
Revive Therapeutics Ltd.
Tel: 1 888 901 0036
Email: mfrank@revivethera.com
Website: www.revivethera.com
Neither the Canadian Securities Exchange nor its Regulation Services Provider has reviewed or accepts responsibility for the adequacy or accuracy of this release.
Cautionary Statement
This press release contains ‘forward-looking information’ within the meaning of applicable Canadian securities legislation. These statements relate to future events or future performance. The use of any of the words “could”, “intend”, “expect”, “believe”, “will”, “projected”, “estimated” and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on Revive’s current belief or assumptions as to the outcome and timing of such future events. Forward looking information in this press release includes information with respect to the Company’s cannabinoids, psychedelics and infectious diseases programs. Forward-looking information is based on reasonable assumptions that have been made by Revive at the date of the information and is subject to known and unknown risks, uncertainties, and other factors that may cause actual results or events to differ materially from those anticipated in the forward-looking information. Given these risks, uncertainties and assumptions, you should not unduly rely on these forward-looking statements. The forward-looking information contained in this press release is made as of the date hereof, and Revive is not obligated to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as required by applicable securities laws. The foregoing statements expressly qualify any forward-looking information contained herein. Reference is made to the risk factors disclosed under the heading “Risk Factors” in the Company’s annual MD&A for the fiscal year ended June 30, 2021, which has been filed on SEDAR and is available under the Company’s profile at www.sedar.com.
FAQ
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