Revive Therapeutics (CSE: RVV) this afternoon reported that it is in the process of pursuing a commercialization plan for the use of Bucillamine in the treatment of Covid-19. The process follows the continued success of phase 3 clinical trials being conducted by the firm.
With respect to the clinical trials, the company is currently continuing with its phase three study. There are two remaining interim analysis timepoints in the study, which are 600 and 800 patients, for which the company has to collect safety and efficacy data on the drug. To date no adverse events or safety concerns have occurred under the trials.
Once each milestone is achieved, the company is to meet with the Independent Data and Safety Monitoring Board for review of the results, with such meetings expected to occur in the third quarter. The company has indicated that as of late, the board has suggested that the firm proceed with a 600 mg high dose of the drug for the remainder of the study.
The company this morning also indicated that following meetings with the board, the firm is prepping for the potential filing of an Emergency Use Authorization with the US Food and Drug Administration. Such a filing will be made if the clinical trials provide evidence to the board to recommend such an authorization.
“We have made tremendous progress over the last few months by engaging over 40 clinical sites and completing patient enrollment to meet its completed and future DSMB interim analysis timepoints which will allow for the Study to continue and to have potential to seek EUA approval from the FDA. We are continuing to add to our clinical site roster in the U.S. and patient enrollment that would expedite the completion of the Phase 3 study.”
Michael Frank, CEO
Finally, Revive is in the midst of discussions with pharmaceutical firms at an international level that are looking to acquire the rights for Bucillamine as a treatment against Covid-19 in several jurisdictions. The development has lead to the pursuit of a commercialization plan that would be based on the success of the phase 3 clinical trial.
Revive Therapeutics last traded at $0.56 on the CSE.
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