Revive Therapeutics Ltd (CSE:RVV, OTCQB:RVVTF) has said it will review the next steps for the Phase 3 clinical trial of Bucillamine, its oral anti-inflammatory and antiviral drug, in patients with mild to moderate COVID-19.
Following its Type C meeting with the US Food and Drug Administration (FDA) and with new hospitalizations of COVID-19 patients now falling, the life sciences company said it has evaluated its strategies for patient recruitment and has opted for a review of the study’s post-dose selection data of 500 subjects for efficacy.
The review, which will be carried out by the Data Safety Monitoring Board (DSMB), will be subject to the current primary endpoint of the trial, which is “the proportion of patients meeting a composite endpoint of hospitalization or death from time of first dose through day 28 following randomization”.
Following the review, the DSMB may recommend continuing the study if it is likely to achieve statistical significance, in which case Revive would assess the likelihood of obtaining hospitalizations for the trial. It could potentially bring in a pharmaceutical partner to support the continuation of the study.
Alternatively, the DSMB could recommend that the study be halted because statistical significance is not likely to be met. In this event, the company said it would accept the decision and seek an evaluation of COVID-19 clinical symptoms data.
Such data - cough, fever, heart rate, and oxygen saturation – would form part of talks with the FDA and potential partners on how to achieve regulatory approval for Bucillamine in the US and internationally.
A third outcome of the DSMB review could be to halt the study early due to positive efficacy showing statistical significance. In this case, Revive would request a meeting with the FDA to determine a path toward obtaining potential regulatory approval.
The company stressed its commitment “to advancing the clinical and commercial development of Bucillamine”. In addition to continuing discussions with the FDA and interested partners on a pathway to regulatory approval, it also plans to develop new formulations for Bucillamine to expand its use in other therapies, specifically targeting rare disorders.
Contact the author at jon.hopkins@proactiveinvestors.com