Molecular Partners stops recruiting hospitalized patients in Covid trial

 

• Following the futility analysis, 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

• The global phase 2-3 EMPATHY study in non-hospitalized patients is still ongoing with topline data from phase 2b expected in early 2022

Ad hoc announcement pursuant to Art. 53 LR:
Molecular Partners AG (SIX: MOLN; NASDAQ: MOLN), a clinical-stage biotech company developing a new class of custom-built protein drugs known as DARPin therapeutics, today announced that a planned futility analysis of ensovibep in the ongoing ACTIV-3 clinical study (NCT04501978) has not met the thresholds required to continue enrollment of adults with COVID-19 in the hospitalized setting. 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 was observed to be generally safe and well tolerated with reported side effects consistent with standard of care.

“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 wish to thank our collaborators and patients for participating in this study. When available, we will share any potential learnings to better inform this population, which is still in great need for treatment options,” said Patrick Amstutz, Ph.D., Molecular Partners’ CEO. “We are encouraged that ensovibep’s safety profile continues to be supported, and we are now focused on its performance for patients in earlier stages of the disease. Ensovibep’s unique mechanism has the potential to meaningfully expand the medical toolkit in our collective fight against the ongoing pandemic, particularly in the face of global under-vaccination and the threat posed by continual new viral strains where we continue to retain potency.”

https://finance.yahoo.com/news/molecular-partners-provides-activ-3-060000619.html