Revive Therapeutics Provides Update on Phase 3 Clinical Trial for Bucillamine in COVID-19
Revive Therapeutics Ltd. (OTCQB: RVVTF) provided an update on its Phase 3 FDA clinical trial for Bucillamine, addressing COVID-19 treatment. The FDA is reviewing the amended protocol which includes a revised primary endpoint that has not yet been accepted. The Data Safety Monitoring Board will evaluate data from approximately 500 subjects to determine the study's continuation based on statistical significance. Revive aims to present a comprehensive data package to the FDA to support Bucillamine's clinical advancement.
- The Data Safety Monitoring Board will review data from around 500 subjects, which may lead to a positive recommendation on the study's continuation.
- The company is committed to seeking FDA agreement on a plan for potential regulatory approval.
- The FDA has not supported the revised primary endpoint for the trial, indicating regulatory hurdles.
- There is uncertainty regarding the trial's continuation depending on the outcomes of the DSMB's review.
TORONTO, Sept. 28, 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, today announced 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.
Further to the Company’s recent submission of the Study’s amended protocol, the FDA provided communication that the amended protocol is still under review and currently does not support the revised primary endpoint of the time to resolution from COVID-19 via the polymerase chain reaction (“PCR”) test. However, the FDA has advised the Company to submit a meeting request to discuss the appropriate endpoints and justification of the relevance of the revised primary endpoint. As a result, to potentially obtain FDA agreement and strengthen the relevance of the revised endpoint, which relied upon the Study’s Pre-Dose selection data, the Data Safety Monitoring Board (“DSMB”) will review the completed Post-Dose selection data of approximately 500 subjects. The DSMB may recommend continuing the Study if there is a trend toward achieving statistical significance, halting the Study early due to statistical significance likely not going to be met, or halting the Study early due to positive efficacy showing statistical significance. Regardless of the outcome, the Company would proceed to seek a meeting with the FDA to agree on a proposed plan for potential regulatory approval.
“We look forward to providing the FDA with a comprehensive data package in support of the clinical advancement of Bucillamine,” said Michael Frank, CEO of Revive.
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.
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