Molecular Partners Announces First Patient Dosed in COVID-19 NIH-Sponsored ACTIV-3 Trial Evaluating Antiviral Candidate Ensovibep

• Global Phase 3 trial designed to investigate safety and efficacy of ensovibep in hospitalized adults with COVID-19
• Ensovibep receives U.S. FDA Fast Track Designation for the treatment of COVID-19 in both hospitalized and ambulatory settings

ZURICH-SCHLIEREN, SWITZERLAND / ACCESSWIRE / June 13, 2021 / Molecular Partners AG (SIX:MOLN), a clinical-stage biotech company developing a new class of custom-built protein drugs known as DARPin® therapeutics, today announced that the first patient has been dosed in a new Phase 3 sub-study evaluating ensovibep, as part of the National Institutes of Health's (NIH) Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) public-private partnership designed to speed development of treatments and vaccine candidates for COVID-19. Molecular Partners also announced that the U.S. Food and Drug Administration (FDA) has granted ensovibep Fast Track designation, which is intended to expedite the development and review of new therapies to treat serious conditions and fill an unmet medical need.

As part of the ACTIV-3 international master protocol, the new Phase 3 sub-study is designed to evaluate the safety and efficacy of ensovibep for the treatment of COVID-19 positive adults in the hospitalized setting. Ensovibep is an anti-SARS-CoV-2 investigational DARPin® therapeutic candidate designed to bind the virus' spike protein on three distinct sites simultaneously to inhibit viral entry into cells and proliferation of the virus. In order to be selected for ACTIV-3, Molecular Partners provided the NIH with relevant data and in addition provided ensovibep for independent preclinical assessments by the NIH.

Initial results from a Phase 1 trial evaluating ensovibep in healthy volunteers were announced in March 2021, indicating that ensovibep was well tolerated with a half-life in the range of 2-3 weeks. These promising results have informed the decision to move forward with the EMPATHY clinical trial program, which initiated enrollment in May 2021, and is being conducted by Novartis, with Molecular Partners as sponsor. The EMPATHY trial is a Phase 2 and 3 study that will seek to enroll 2,100 patients with COVID-19 in the ambulatory setting, to evaluate the safety and efficacy of ensovibep in preventing worsening symptoms and hospitalizations.