Revive Therapeutics Ltd (CSE:RVV, OTCQB:RVVTF) said it has received positive comments from the Food and Drug Administration (FDA) regarding the company’s request to determine and agree on new primary efficacy endpoints for its Phase 3 clinical trial to evaluate the safety and effectiveness of bucillamine, an oral drug with anti-inflammatory and antiviral properties, in patients with mild-to-moderate coronavirus (COVID-19).
The potential new primary efficacy endpoints include the rate of sustained clinical resolution of symptoms of COVID-19 which the company said addresses the shift in COVID-19 clinical outcomes observed over the course of the pandemic and, therefore, are more meaningful study endpoints for the FDA to consider to potential Emergency Use Authorization.
Revive added that the FDA agreed the company may unblind the pre-dose selection data for the first 210 patients of the study to further support the new primary endpoint.
READ: Revive Therapeutics submits request to FDA for potential new endpoints for Bucillamine clinical trial to treat COVID-19
“Before unblinding the pre-dose selection data for the first 210 patients, the company will submit a Data Access Plan to the FDA in early June 2022 with the aim to unblind the pre-dose selection data and submit the amended study protocol with the new primary efficacy endpoints to the FDA,” the company said.
Following this, the Data Safety and Monitoring Board (DSMB) is scheduled to meet and evaluate the interim clinical and safety data and may make a recommendation on continuing the study or halting it early due to positive efficacy based on other clinical outcomes such as the rate of sustained clinical resolution of symptoms of COVID-19.
“The DSMB supported the continuation of the study in its last meeting as there were no serious adverse events or safety concerns reported,” Revive said.
The company said it was not making any express or implied claims that its product has the ability to eliminate or cure COVID-19 at this time.
Revive Therapeutics is a life sciences company focused on the research and development of therapeutics for infectious diseases and rare disorders, as well as central nervous system and inflammatory disorders.
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