Revive Therapeutics has reported that its Phase III clinical trial of oral Bucillamine for the treatment of mild to moderate Covid-19 has failed to achieve statistical significance on the clinical endpoints.
The study assessed the efficacy and safety of the therapy in 713 patients.
At the first interim analysis for the trial’s post-dose selection phase, the independent Data Safety Monitoring Board (DSMB) recommended Bucillamine 600mg/day dosage. No hospitalisations were reported.
In this study, patients received Bucillamine 300mg (low dose) a day or placebo.
The proportion of patients meeting a composite endpoint of hospitalisation or death from the first day of dosage until day 28 is the study’s primary endpoint.
No deaths were reported. However, four members were hospitalised, including one from the low-dose group and the remaining from placebo.
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The study also evaluated additional endpoints such as clinical symptoms data including cough, fever, heart rate, and oxygen saturation.
Time to polymerase chain reaction (PCR) resolution, and quantitative PCR-based assessment of SARS CoV-2 viral load were also measured.
Both the treatment groups did not show any improvements in clinical symptoms and viral load data.
DSMB recommended a halt of the study using 300mg Bucillamine due to a very low probability of the trial’s success.
However, Bucillamine showed a 29.1% improvement in oxygen saturation levels over placebo in preliminary analyses. Both groups also demonstrated a median of 11 days for time to PCR negative and stay negative.
Based on the data analysed from the trial, the company plans to advance the clinical and commercial development of Bucillamine.