- Screened approximately 700 subjects and expanding to Eastern Europe, including Turkey, as part of its clinical diversification plans to support global regulatory approvals
- No serious adverse events and safety concerns reported to date in the Phase 3 clinical trial
- Expected to complete enrollment in Q1-2022
TORONTO, Dec. 29, 2021 – 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.
To date, the Study has screened approximately 700 subjects. The Independent Data and Safety Monitoring Board supported the continuation of the Study in its last meeting as there were no serious adverse events or safety concerns.
In light of Phase 3 clinical studies and FDA approvals of oral antiviral treatments by Pfizer and Merck, it was evident that to ensure a diversified patient population to support future global regulatory submissions for Bucillamine, including the FDA, the Company has decided to fill a part of its patient enrollment quota outside of the U.S. and target Eastern Europe, such as in Turkey, where the reported cases of COVID-19 are high with 32,176 new COVID-19 infections reported on December 28, 2021 (https://covid19.saglik.gov.tr/TR-66935/genel-koronavirus-tablosu.html). In addition, the Company in collaboration with Delta Health will add research sites from the largest hospital group in Turkey, MLP Care and Istinye University, which has 30 directly owned hospitals in 15 cities and its affiliated university medical centers (including state-of-the-art certified laboratories) for a combined capacity of over 6000 in-patient hospital beds across Turkey.
As a result of the Company’s plans to diversify its patient population globally, incorporate viral load and anti-inflammatory markers, and its ongoing discussions with international pharmaceutical companies seeking to obtain commercial rights to Bucillamine as a treatment for COVID-19 in various countries in Europe, India and Asia, the Phase 3 clinical study enrollment completion period is expected in Q1-2022. The Company still expects to file an Emergency Use Authorization (“EUA”) with the FDA if the blinded results provide evidence to the DSMB’s final review to recommend to pursue EUA for Bucillamine to treat mild to moderate COVID-19.
Michael Frank, CEO of the Company commented, “We are now focused on completing the Phase 3 study in a manner which will provide practical antiviral, anti-inflammatory and a diversified patient population. With the recent onset of the Omicron variant we have made some of the above adjustments to the trial.”
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.
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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 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.