Revive Therapeutics Announces Finalization of Amended Phase

TORONTO, Oct. 14, 2022 (GLOBE NEWSWIRE) — Revive Therapeutics Ltd. (“Revive” or the “Company”) (OTCQB: RVVTF) (CSE: RVV) (FRANKFURT:31R), a specialty life sciences firm centered on the analysis and improvement of therapeutics for medical wants and uncommon issues, introduced right this moment that it has finalized an amended protocol to the U.S. Food & Drug Administration (“FDA”) for the Company’s Phase 3 medical trial (the “Study”) (NCT04504734) to guage the protection and efficacy of Bucillamine, an oral drug with anti-inflammatory and antiviral properties, in sufferers with gentle to average COVID-19.

After the medical crew’s additional evaluation the Company will now be submitting to the FDA the Study’s amended protocol with a brand new main efficacy endpoint, particularly, assessing the distinction within the proportion of members with enchancment in at the very least two COVID-19 associated medical signs on or earlier than Day 14 in contrast with baseline between Bucillamine versus placebo. Additional secondary endpoints might embody the time to the polymerase chain response decision, medical consequence (dying or hospitalization), illness severity, supplemental oxygen use, and development of COVID-19. Should the FDA agree with the revised protocol, the Data Safety Monitoring Board (“DSMB”) will overview the finished Post-Dose choice information of roughly 500 topics within the context of the brand new main endpoint. The DSMB might advocate persevering with the Study if there’s a development towards reaching statistical significance, halting the Study early as a consequence of statistical significance probably not going to be met, or halting the Study early as a consequence of constructive efficacy exhibiting statistical significance. Regardless of the end result, the Company would proceed to hunt a gathering with the FDA to agree on a proposed plan for potential regulatory approval.

The Company shouldn’t be making any specific or implied claims that its product has the power to eradicate or treatment COVID-19 (SARS-2 Coronavirus) right now.        

About Revive Therapeutics Ltd.

Revive is a life sciences firm centered on the analysis and improvement of therapeutics for infectious illnesses and uncommon issues, and it’s prioritizing drug improvement efforts to take benefit of a number of regulatory incentives awarded by the FDA comparable to Orphan Drug, Fast Track, Breakthrough Therapy and Rare Pediatric Disease designations. Currently, the Company is exploring the use of Bucillamine for the potential remedy of infectious illnesses, with an preliminary concentrate on extreme influenza and COVID-19. With its acquisition of Psilocin Pharma Corp., Revive is advancing the event of Psilocybin-based therapeutics in numerous illnesses and issues. Revive’s cannabinoid pharmaceutical portfolio focuses on uncommon inflammatory illnesses and the corporate was granted FDA orphan drug standing designation for the use of Cannabidiol (CBD) to deal with autoimmune hepatitis (liver illness) and to deal with ischemia and reperfusion harm from organ transplantation. For extra info, go to www.ReviveThera.com.

For extra info, please contact:

Michael Frank
Chief Executive Officer
Revive Therapeutics Ltd.
Tel: 1 888 901 0036
Email: [email protected]
Website: www.revivethera.com

Neither the Canadian Securities Exchange nor its Regulation Services Provider has reviewed or accepts accountability for the adequacy or accuracy of this launch.

Cautionary Statement

This press launch incorporates ‘forward-looking information’ inside the that means of relevant Canadian securities laws. These statements relate to future occasions or future efficiency. The use of any of the phrases “could”, “intend”, “expect”, “believe”, “will”, “projected”, “estimated” and related expressions and statements referring to issues that aren’t historic information are supposed to determine forward-looking info and are based mostly on Revive’s present perception or assumptions as to the end result and timing of such future occasions. Forward trying info on this press launch consists of info with respect to the Company’s cannabinoids, psychedelics and infectious illnesses packages. Forward-looking info is predicated on affordable assumptions which were made by Revive on the date of the data and is topic to recognized and unknown dangers, uncertainties, and different components which will trigger precise outcomes or occasions to vary materially from these anticipated within the forward-looking info. Given these dangers, uncertainties and assumptions, you shouldn’t unduly depend on these forward-looking statements. The forward-looking info contained on this press launch is made as of the date hereof, and Revive shouldn’t be obligated to replace or revise any forward-looking info, whether or not in consequence of new info, future occasions or in any other case, besides as required by relevant securities legal guidelines. The foregoing statements expressly qualify any forward-looking info contained herein. Reference is made to the chance components disclosed below the heading “Risk Factors” within the Company’s annual MD&A for the fiscal yr ended June 30, 2021, which has been filed on SEDAR and is out there below the Company’s profile at www.sedar.com.