Revive Therapeutics Ltd (CSE:RVV, OTCQB:RVVTF) has provided an update on its Type C meeting written responses received from the US Food & Drug Administration (FDA) to obtain agreement on the proposed protocol endpoints for the company’s Phase 3 Study to evaluate the safety and efficacy of Bucillamine, an oral drug with anti-inflammatory and antiviral properties, in patients with mild to moderate coronavirus (COVID-19).
The life sciences company said the FDA recommended additional revised primary symptom-based endpoints, which should cover the evaluation of time to sustained recovery assessed over an appropriate duration, evidence of subjects experiencing resolution of COVID-19 related symptoms and the element of sustained symptom resolution.
Revive noted that in response to the FDA recommendations it will provide an amended statistical analysis plan to support unblinding of the data to potentially provide evidence of efficacy while outlining how symptoms are assessed and with what frequency, how improvement will be defined, and how the endpoint will be analyzed.
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The company added that proposed secondary endpoints can also be included in the study to assess the impact of treatment on how a patient feels, functions, or survives.
Revive also stated that once the FDA accepts the revised statistical analysis plan (SAP) and study protocol, the Data Safety Monitoring Board (DSMB) will review the study’s completed blinded Post-Dose selection data of about 500 subjects in accordance with the accepted study protocol.
Depending on the outcome of the DSMB review, the company said it could proceed to unblind the data and request a meeting with the FDA to review the data providing evidence of the potential efficacy of Bucillamine for COVID-19 and determine the next steps.
The study’s proposed primary symptom-based endpoints are partly due to the evolving and current state of COVID-19, where many patients with COVID-19 are either asymptomatic or experience mild to moderate illness and could be managed in the outpatient setting, according to the company.
Furthermore, Revive noted that based on Bucillamine’s proposed mode of action, it is believed that the speed of symptom resolution and reduced viral shedding, if given promptly, could help mitigate the disease burden globally.
Revive Therapeutics is a life sciences company focused on the research and development of therapeutics for infectious diseases and rare disorders, and it is prioritizing drug development efforts to take advantage of several regulatory incentives awarded by the US Food and Drug Administration (FDA) such as Orphan Drug, Fast Track, Breakthrough Therapy and Rare Pediatric Disease designations.
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