Revive Therapeutics Ltd (CSE:RVV, OTCQB:RVVTF) has issued an update on the Phase 3 trial of its drug Bucillamine in patients with mild to moderate COVID-19.
Back in March, the company met with the US Food and Drug Administration (FDA) to get approval for the proposed endpoints of the study of Bucillamine. The agency recommended that the primary symptom-based endpoint should cover the evaluation of time to sustained recovery assessed, evidence of subjects experiencing resolution of Covid-19 related symptoms as well as the element of sustained symptom resolution.
Now, Revive Therapeutics has chosen to stick with the primary endpoint of the proportion of patients meeting a composite endpoint of hospitalization or death from the time of first dose after 28 days.
The company noted that although the study was initially designed for a “hospitalization or death” primary endpoint, it was not designed to take into account all of the symptom assessments and supporting data outlined in the FDA guidelines to warrant a primary symptom-based endpoint for Covid-19 studies.
The company made efforts with the FDA to allow for specific primary symptom-based endpoints but was essentially told that moving away from the primary endpoint and/or unbinding the subject data would jeopardize any chance of potential future regulatory approval, according to a statement.
With that in mind, the company said it plans to continue discussions with the FDA regarding a path to future potential regulatory approval under the current study’s objectives and work with the study’s current participating clinical sites (and potential new sites) to develop a defined recruitment plan that prioritizes subjects recognized to be at higher risk for developing severe COVID-19 to achieve the study’s objectives.
Revive also plans to develop reformulation strategies of Bucillamine to expand on its potential therapeutic utility targeting rare disorders that may come with regulatory incentives awarded by the FDA, such as orphan drug (i.e. ischemia-reperfusion injury, cystinuria), fast track and breakthrough therapy designations.
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