FDA asks Revive to amend main goals of phase 3 trial for COVID drug

Revive Therapeutics (OTCQB:RVVTF) said the U.S. Food and Drug Administration (FDA) recommended additional revised primary symptom-based goals for a phase 3 trial of oral therapy bucillamine to treat patients with mild to moderate COVID-19.

The company had a Type C meeting with FDA after which it received written response from the agency.

The FDA recommended that proposed main symptom-based goals should cover the evaluation of time to sustained recovery checked over an appropriate duration, proof of patients experiencing resolution of COVID-19 related symptoms and the element of sustained symptom resolution.

In addition, the FDA needs Revive to provide a revised statistical analysis plan (the SAP) which includes the FDA recommendations of the proposed primary symptom-based goals for the trial and outlines how symptoms are assessed and with what frequency, how improvement will be defined, and how the goal will be evaluated, the company added.

Revive's proposed secondary goals can also be included in the trial to check treatment impact as how a patient feels, functions or survives, according to the company.

Revive said it plans to amend the SAP and trial protocol, incorporating the suggestions made by the FDA.

In September 2022, too the FDA did not support the revised main goal of the phase 3 trial. Following this, the agency recommended a Type C meeting to discuss the overall development plan and the latest revised goals.

In January, Revive had said that it would submit an updated briefing package to the FDA to reach agreement on the trial's goals.