Revive Therapeutics Provides Update on Phase 3 Clinical Trial for Bucillamine in COVID-19
Revive Therapeutics Ltd. (OTCQB: RVVTF) announced updates on its FDA Phase 3 clinical trial evaluating Bucillamine for mild to moderate COVID-19. The company will amend the study protocol based on newly analyzed data, proposing new primary efficacy endpoints such as time to symptom resolution and sustained clinical recovery. This aligns with evolving COVID-19 treatment needs, particularly with the rise of the Omicron variant. Revive emphasizes that it does not claim Bucillamine can cure COVID-19.
- Amending the study protocol aims to enhance potential FDA approval chances.
- The proposed endpoints reflect updated clinical outcomes in COVID-19 treatment.
- No positive clinical trial results have been reported yet.
- The company's claims do not assert Bucillamine can cure COVID-19, which may limit market perception.
TORONTO, Aug. 16, 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, is pleased to provide 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.
After a lengthy review and analysis of the supporting pre-dose selection data (the “Data”) from the Study by the unblinded statistician team, the Company will now amend the Study protocol with the proposed new primary efficacy endpoints and submit to the FDA for further discussion and agreement. The proposed new primary efficacy endpoints may include the time to resolution from COVID-19 via the polymerase chain reaction (“PCR”) test and the rate of sustained clinical resolution of certain symptoms of COVID-19. These proposed endpoints address the shift in COVID-19 clinical outcomes observed over the course of the pandemic, and, therefore, have more meaningful study endpoints for the FDA to consider for regulatory approval.
The Company believes that with the Omicron variant, including the spreading of BA.5, currently the dominant strain, there is an urgent need to treat symptom resolutions in addition to preventing hospitalizations.
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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