- Revive Therapeutics (RVV) has provided an update regarding its Bucillamine phase three study requirements from the U.S. Food and Drug Administration (FDA)
- Bucillamine is an oral drug developed to treat mild cases of COVID-19 and influenza
- The FDA recommended that the study’s proposed primary symptom-based endpoints should be revised
- Revisions include changing evaluation times, symptom frequency assessment, and how improvement will be defined
- RVV will incorporate these new endpoints into its study and seek further approval
- Revive Therapeutics (RVV) is down 14.81 per cent, trading at $0.11 as of 10:49 a.m. EST
Revive Therapeutics (RVV) received an update from the US FDA concerning its Bucillamine phase three study.
Bucillamine is an oral drug developed by RVV with anti-inflammatory and antiviral properties to treat patients with mild to moderate COVID-19 and influenza.
According to the company, the FDA recommended that the study’s proposed primary symptom-based endpoints should cover the time to a sustained recovery assessed over an “appropriate,” how symptoms are assessed and with what frequency, how improvement will be defined, and how the endpoint will be analyzed.
RVV accredited the study’s current proposed primary symptom-based endpoints partly to the continually evolving 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.
Plan revision required as next step
Additionally, the FDA has asked RVV to revise a statistical analysis plan (SAP) that incorporates the new recommendations. The company’s proposed secondary endpoints may also be included in the study to assess the impact of treatment on how a patient feels, functions, or survives.
As a result, RVV stated it will amend the SAP and study protocol to include the FDA suggestions. Once revised and accepted, the Data Safety Monitoring Board (DSMB) will review the study’s completed blinded post-dose selection data of up to 500 subjects.
Depending on the outcome of the review, the company may move 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.
Revive Therapeutics (RVV) is down 14.81 per cent, trading at $0.11 as of 10:49 a.m. EST.