Revive Therapeutics Ltd (CSE:RVV, OTCQB:RVVTF) said it has been in discussions with the Biomedical Advanced Research and Development Authority (BARDA) to explore the potential of securing advanced development and possible commercial scale-up funding for Bucillamine, its COVID-19 oral drug.
In an update on Phase 3 of its US Food & Drug Administration (FDA) clinical trial to evaluate the safety and efficacy of Bucillamine, the Toronto-based company said discussions surrounding Bucillamine’s attributes and clinical potential were determined to be relevant for consideration, which could provide support to the company’s current efforts.
“We continue to advance our efforts in positioning Bucillamine as a potential treatment for COVID-19 that is relevant to the current state of the disease, and our ongoing discussions with BARDA are promising for potential development and commercial support as we progress in our Phase 3 study,” said Revive CEO Michael Frank in a statement.
READ: Revive Therapeutics touts publication of positive research data with Bucillamine in coronavirus
Revive said it is concurrently working with its statistical advisory team for the planning of the data analysis and interpretation of statistical outcomes from the clinical trial for the Data Safety and Monitoring Board (DSMB).
This will allow for the DSMB to make a recommendation on the clinical trial or advise on 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 company noted.
“The company has made efforts in determining the appropriate primary and secondary clinical endpoints for FDA consideration, which potentially could allow for an objective path to meet with the FDA for Emergency Use Authorization,” Revive said.
The company added that it is not making any express or implied claims that Bucillamine, an oral drug with anti-inflammatory and antiviral properties to potentially treat patients with mild to moderate symptoms, has the ability to eliminate or cure COVID-19 at this time.
Contact the author at jon.hopkins@proactiveinvestors.com