- Section 3 scientific trial ongoing with subsequent DSMB assembly at 600 accomplished sufferers.
- At the moment at 41 scientific websites and to interact a minimal of fifty scientific websites.
- Purpose to finish enrollment in Q3-2021 and FDA EUA submission in late-Q3/This fall-2021.
- Getting ready business actions for worldwide drug approvals.
TORONTO, July 15, 2021 (GLOBE NEWSWIRE) — Revive Therapeutics Ltd. (“Revive” or the “Firm”) (OTCQB: RVVTF) (CSE: RVV) (FRANKFURT: 31R), a specialty life sciences firm targeted on the analysis and growth of therapeutics for medical wants and uncommon problems, is happy to supply an replace on the Firm’s U.S. Meals & Drug Administration (“FDA”) Section 3 scientific trial (the “Examine”) to judge the protection and efficacy of Bucillamine in sufferers with gentle to reasonable COVID-19.
The Examine is a randomized, double-blind, placebo-controlled trial and the protection and efficacy information at every remaining interim evaluation timepoint, which presently are 600 and 800 accomplished sufferers, are solely made accessible to the Impartial Information and Security Monitoring Board (“DSMB”) for overview and suggestions on continuation, stopping or modifications to the conduct of the Examine.
The subsequent DSMB conferences will happen at 600 and 800 accomplished sufferers, that are anticipated to be held in Q3-2021. The Firm is continuous the Section 3 scientific trial with the latest really helpful 600 mg excessive dose as chosen by the DSMB.
Thus far, the continuing Examine has not seen any critical opposed occasions or security considerations that required the DSMB to be notified or take motion on. Within the occasion of any critical security considerations, the DSMB can be notified to find out any dangers and supply its suggestions.
The Firm presently has partnered with 40 scientific websites in fourteen states together with: Alabama, Arkansas, California, Florida, Georgia, Illinois, Michigan, Nevada, New York, North Carolina, Ohio, South Carolina, Tennessee and Texas; additionally one scientific website in Puerto Rico. Revive will proceed to develop to a minimal of fifty scientific websites throughout the present states and in COVID-19 sizzling spot states.
Additional to the DSMB overview and suggestions on every interim evaluation intervals, the Firm is making ready for the potential of submitting an Emergency Use Authorization (“EUA”) with the FDA within the occasion that the blinded outcomes present proof to the DSMB to advocate to pursue EUA for Bucillamine to deal with gentle to reasonable COVID-19. The Firm is on monitor to satisfy its deliberate enrollment objective for the Examine in Q3-2021 and intention to file EUA with the FDA.
The Firm is in discussions with respected worldwide pharmaceutical firms searching for to acquire business rights to Bucillamine as a therapy for COVID-19 in numerous international locations in Europe, India and Asia. In mild of those discussions, Revive is pursuing a commercialization plan that will leverage the scientific outcomes from the U.S. Section 3 examine to permit for drug approvals globally.
Michael Frank, CEO of the Firm commented, “We’re happy with the standing of our Section 3 examine in COVID-19 with the intention to hunt EUA approval from the FDA for Bucillamine within the therapy of gentle to reasonable COVID-19 sufferers. We’ve got made great progress over the previous couple of months by partaking over 40 scientific websites and finishing affected person enrollment to satisfy its accomplished and future DSMB interim evaluation timepoints which can enable for the Examine to proceed and to have potential to hunt EUA approval from the FDA. We’re persevering with so as to add to our scientific website roster within the U.S. and affected person enrollment that will expedite the completion of the Section 3 examine. Additionally, we’re in discussions with worldwide pharmaceutical firms searching for to acquire commercialization rights in numerous international locations around the globe.”
Concerning the Section 3 Scientific Trial (ClinicalTrials.gov Identifier: NCT04504734)
The Section 3 confirmatory scientific trial titled, “A Multi-Middle, Randomized, Double-Blind, Placebo-Managed Examine of Bucillamine in Sufferers with Delicate-Reasonable COVID-19”, will enroll as much as 1,000 sufferers that can be randomized to Bucillamine or Placebo for as much as 14 days. The first goal is to match the frequency of hospitalization or dying in sufferers with mild-moderate COVID-19 receiving Bucillamine remedy with these receiving placebo. The first endpoint is the proportion of sufferers assembly a composite endpoint of hospitalization or dying from the time of the primary dose by way of Day 28 following randomization. Efficacy can be assessed by evaluating scientific outcomes (dying or hospitalization), illness severity utilizing the 8-category NIAID COVID ordinal scale, supplemental oxygen use, and development of COVID-19 between sufferers receiving standard-of-care plus Bucillamine and sufferers receiving standard-of-care plus placebo. Security can be assessed by reported pre-treatment opposed occasions and treatment-emergent opposed occasions (together with critical opposed occasions and opposed occasions of particular curiosity), laboratory values (hematology and serum chemistry), important indicators (coronary heart charge, respiratory charge, and temperature), and peripheral oxygen saturation. The unbiased DSMB will actively monitor interim information for the continuing security of sufferers and can advocate continuation, stopping or modifications to the conduct of the examine primarily based on the interim evaluation experiences.
The Firm will not be making any specific or implied claims that its product has the flexibility to eradicate or treatment COVID-19 (SARS-2 Coronavirus) right now.
About Revive Therapeutics Ltd.
Revive Therapeutics Ltd. (OTCQB: RVVTF) (CSE: RVV) (FRANKFURT: 31R) is a biotech firm targeted on the analysis, growth and commercialization of therapeutics for infectious illnesses and uncommon problems, and psychedelics to deal with psychological well being and substance abuse problems. Revive prioritizes its drug growth packages to make the most of numerous regulatory incentives awarded by the FDA reminiscent of Orphan Drug, Quick Observe and Breakthrough Remedy designations, in addition to Emergency Use Authorizations. At the moment, the Firm is exploring using an oral drug, Bucillamine, for the potential therapy of infectious illnesses, with an preliminary concentrate on COVID-19, which is presently being evaluated in an FDA Section 3 scientific trial to deal with gentle to reasonable COVID-19. The Firm has a strong psychedelics pharmaceutical program with the event of an oral skinny movie strip delivering psilocybin to deal with psychological well being and substance abuse problems and advancing the novel use of psilocybin to deal with traumatic mind damage and stroke. Revive’s cannabinoid pharmaceutical portfolio focuses on uncommon inflammatory illnesses and the Firm was granted FDA orphan drug designation for using Cannabidiol to deal with autoimmune hepatitis and to deal with ischemia and reperfusion damage from organ transplantation. For extra info, go to www.ReviveThera.com.
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