Revive Therapeutics Announces Submission of Type C Meeting Request to FDA for Amended Protocol Agreement of Phase 3 Clinical Study for Bucillamine in the Treatment of COVID-19

Rhea-AI Summary

Revive Therapeutics Ltd. (RVVTF) has submitted a Type C meeting request to the FDA to discuss revised protocol endpoints for its Phase 3 clinical trial evaluating Bucillamine's efficacy in treating mild to moderate COVID-19. This step is crucial for progressing the trial and the company anticipates a meeting date from the FDA soon. Revive is focused on developing therapeutics for rare disorders and infectious diseases, including severe influenza and COVID-19, while holding several FDA designations aimed at fast-tracking drug development.

Positive

• Submission of Type C meeting request to FDA for Phase 3 trial on Bucillamine.
• Anticipation of FDA feedback to advance clinical trial process.
• Company focuses on developing therapeutics for infectious diseases and rare disorders.

Negative

• None.

TORONTO, Dec. 22, 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, announced that it has submitted the Type C meeting request package to the U.S. Food & Drug Administration (“FDA”) to obtain agreement on the revised protocol endpoints for the Company’s 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. Following the submission of the Type C meeting request package, the Company expects to hear from the FDA on a firm date for the meeting.

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, 2022, which has been filed on SEDAR and is available under the Company’s profile at www.sedar.com.

FAQ

What is the purpose of Revive Therapeutics' Phase 3 clinical trial?

The Phase 3 clinical trial aims to evaluate the safety and efficacy of Bucillamine in patients with mild to moderate COVID-19.

When did Revive Therapeutics submit the Type C meeting request to the FDA?

Revive Therapeutics submitted the Type C meeting request on December 22, 2022.

What does the Type C meeting request entail for Revive Therapeutics?

The Type C meeting request seeks FDA agreement on revised protocol endpoints for Bucillamine's clinical trial.

What other therapeutic areas is Revive Therapeutics focused on?

Revive is also exploring treatments for severe influenza and developing Psilocybin-based therapeutics.

What is the stock symbol for Revive Therapeutics?

The stock symbol for Revive Therapeutics is RVVTF.