MLLCF - Dosing underway in Molecular Partners' NIH-sponsored COVID-19 trial evaluating ensovibep

The first patient has been dosed in Molecular Partners' (MLLCF) new Phase 3 sub-study evaluating ensovibep, as part of the National Institutes of Health's ((NIH)) partnership designed to speed development of treatments and vaccine candidates for COVID-19.Also, the FDA has granted ensovibep Fast Track designation. The Phase 3 sub-study is designed to evaluate the safety and efficacy of ensovibep in COVID-19 positive adults in the hospitalized setting.The primary efficacy endpoint is the time from randomization to participants' sustained recovery for 14 days after release from the hospital.The ACTIV-3 trial arm is planned to initially enroll 300 participants who will receive either ensovibep or placebo and standard of care, including remdesivir.The protocol includes an interim analysis for futility after the first 300 patients have been randomized and recruited. If positive, the trial will enroll an additional 700 participants.

For further details see:

Dosing underway in Molecular Partners' NIH-sponsored COVID-19 trial evaluating ensovibep