Revive Therapeutics Ltd (CSE:RVV, OTCQB:RVVTF) has updated further on its Phase 3 clinical trial for Bucillamine in coronavirus (COVID-19), saying it has now submitted a Data Access Plan to the US Food and Drug Administration (FDA), in a bid to amend the parameters of the study.
As reported in late May, the firm received positive comments from the FDA over its request to determine and agree on new primary efficacy endpoints.
"The proposed new primary efficacy endpoints may include the rate of sustained clinical resolution of symptoms of COVID-19, which addresses the shift in COVID-19 clinical outcome observed over the course of the pandemic, and, therefore, to have more meaningful study endpoints for the FDA to consider for potential Emergency Use Authorization," said Revive in a statement.
"The FDA has agreed that the company may unblind the pre-dose-selection data for the first 210 patients of the study to further support the new primary endpoint," it added.
READ: Revive Therapeutics receives positive feedback from FDA about potential new endpoints for its Bucillamine clinical trial to treat COVID-19
Also, the Data Safety and Monitoring Board (DSMB) are scheduled to meet thereafter to evaluate the interim clinical and safety data and may make a recommendation on continuing the trial or advise on halting it early due to positive efficacy based on other clinical outcomes, noted life sciences firm Revive.
The company said it believes that with the Omicron variant, including the BA.2 variant, being the dominant strain over the Delta variant, there is an "urgent need to treat symptom resolutions in addition to preventing hospitalizations."
Revive Therapeutics is focused on the research and development of therapeutics for infectious diseases and rare disorders and aims to take advantage of several regulatory incentives awarded by the FDA, such as orphan drug, fast track, breakthrough therapy and rare pediatric disease designations.
Contact the author at giles@proactiveinvestors.com