Revive Therapeutics (CSE: RVV) announced this morning that it is expanding its phase 3 clinical trials following the approval granted by the US Food and Drug Administration. The company is expanding its plans to include both Asia-Pacific Countries (APAC) as well as Canada.
The phase 3 trials, which consist of the company studying the use of Bucillamine in the treatment of mild-moderate COVID-19 and other infectious diseases, are currently expected to open for patient enrollment and dosing next month in September. Revive and its clinical trial partners are currently evaluating potential clinical sites, which includes the previously announced states of California, Florida, Arizona and Texas as well as in the additional US states and now Canada and the APAC region.
The announcement of the expansion of the clinical trial regions follows the announcement last week that the company has signed a memorandum of understanding with Attwill Medical Solutions Sterilflow, LP, the same firm utilized by Vaxart Inc (NASDAQ: VXRT) for its clinical stage oral COVID vaccine, as a resource for clinical packaging and distribution of the phase 3 clinical trial. Further vendor agreements are in the process of being finalized currently.
“With the approval from the FDA to conduct the Phase 3 clinical trial in COVID-19 and our progress that we have made to date, we are now establishing plans to complement and support our initiatives in the U.S. to include clinical sites in APAC and Canada.”
Michael Frank, CEO of Revive Therapeutics
The scientific rationale for the use of Bucillamine in the treatment of COVID-19, as well as the details of the phase 3 confirmatory clinical study, can be found here.
Revive Therapeutics last traded at $0.28 on the CSE.
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