Pharma Focus Europe

Revive Therapeutics Releases Findings From Phase 3 Clinical Study on Bucillamine for COVID-19 Treatment

Friday, July 07, 2023

Revive Therapeutics Ltd. recently announced the findings of its Phase 3 clinical trial investigating the safety and effectiveness of oral Bucillamine in patients with mild to moderate COVID-19. However, the study did not yield statistically significant results for the clinical endpoints. The trial enrolled 713 patients with mild-to-moderate COVID-19.

The primary endpoint of the study was the proportion of patients who met a composite endpoint of hospitalization or death from the time of the first dose through Day 28 after randomization. There were no deaths reported, and four hospitalizations occurred during the study. Three hospitalizations were from the placebo group, while one hospitalization was from the Bucillamine low-dose group (300mg/day). The Bucillamine high-dose group (600mg/day), recommended by the independent Data Safety Monitoring Board (DSMB) at the first interim analysis, had no hospitalizations. The low-dose group was discontinued following the DSMB's recommendation after the first interim analysis. Although the number of hospitalizations was small, it showed a positive trend in the post-dose selection phase of the study. However, based on conditional power simulation, the estimated likelihood of achieving statistical significance after completing the study and conducting the final analysis was only 5.48%. As a result, the DSMB advised halting the study due to the low probability of success and the changing clinical outcomes observed in COVID-19 patients.

The company also examined additional study endpoints, including COVID-19 clinical symptoms, time to polymerase chain reaction (PCR) resolution, and viral load. There was no significant overall improvement trend between the Bucillamine and placebo groups for clinical symptoms and viral load data. However, preliminary analyses revealed that for patients with baseline oxygen saturation below 96%, Bucillamine demonstrated a 29.1% improvement over placebo in the time to reach normal oxygen saturation (SpO2). Additionally, both the Bucillamine and placebo groups had a median time of 11 days to achieve PCR-negative results. However, the Bucillamine group had a slightly shorter 75th percentile of 14 days compared to 15 days in the placebo group. Further analysis of the study data is ongoing and may provide insights for decisions regarding the development and commercialization of Bucillamine.

Despite the study's results, Revive Therapeutics remains committed to advancing the clinical and commercial development of Bucillamine. The company plans to explore reformulating Bucillamine into intravenous and inhaled versions to expand its potential therapeutic applications, particularly targeting rare disorders such as ischemia-reperfusion injury, acute respiratory distress syndrome, and potential medical countermeasures. They also intend to collaborate with pharmaceutical partners to pursue regulatory approvals and new clinical studies for infectious, inflammatory, and respiratory disorders. Furthermore, Revive Therapeutics will explore potential funding opportunities from government entities, including the Biomedical Advanced Research and Development Authority (BARDA) and the Administration for Strategic Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services (HHS).

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