Molecular Partners' Covid 19 drug falters in Phase 3 trials

A planned futility analysis of Molecular Partners’ ensovibep in the ongoing ACTIV-3 clinical study has not met the thresholds required to continue enrollment of adults with COVID-19 in the hospitalized setting. The independent Data and Safety Monitoring Board (DSMB) recommends that the recruitment of patients in the ensovibep arm of ACTIV-3 not continue in hospitalized patients.

This global Phase 3 ACTIV-3 platform study is being conducted by the National Institutes of Health (NIH) as part of its Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) program. ACTIV is evaluating multiple therapies for COVID-19 to see what, if any, benefit can be seen over current standard of care. At the time of the analysis, 470 patients had been randomized in the ensovibep arm of the study.

Ensovibep is the lead therapeutic candidate in Molecular Partners’ infectious disease pipeline. The global phase 2-3 EMPATHY study in non-hospitalized patients is still ongoing with topline data from phase 2b expected in early 2022. “Demonstrating efficacy in hospitalized patients with COVID-19 has proven particularly challenging for antiviral therapies, with most investigational agents tested so far in the ACTIV-3 study not passing futility criteria – potentially due to the multi-systemic inflammatory component of late-stage COVID-19 disease. We are now focused on its performance for patients in earlier stages of the disease,” said Patrick Amstutz, Molecular Partners’ CEO.

Molecular Partners and Novartis are collaborating on the development of ensovibep and are evaluating it in another global late-stage study, EMPATHY, which is designed to assess ensovibep’s ability to rapidly reduce viral load and prevent worsening of symptoms and hospitalization of patients who are in the early stages of disease. Novartis is conducting EMPATHY with Molecular Partners as sponsor, with topline interim data for the first 400 patients expected in early 2022.

(Press release / SK)