Molecular Partners, a biopharma company from Schlieren, has administered its coronavirus candidate ensovibep to a first patient with symptomatic COVID-19 disease in a clinical Phase 2 trial. According to a press release, the study in the Netherlands will enroll up to 40 patients in two dose cohorts.
As recently as March, Molecular Partners had announced positive initial data from its Phase 1 study of ensovibep in healthy volunteers, which had been conducted in collaboration with Novartis. Additionally to the Phase 2 trial in the Netherlands, ensovibep will be tested in two global, placebo controlled, double blinded trials: a Phase 2-3 trial in an ambulatory patient setting (named EMPATHY) and a Phase 3 trial in a hospitalized patient setting. This ACTIV-3 study is sponsored by the National Institutes of Health (NIH) in Maryland, USA, and will investigate the safety and efficacy of the therapeutic candidate in adults hospitalized with a COVID-19 diagnosis. Molecular Partners hopes to achieve clinical proof-of-concept and potential emergency use authorization within 2021.
Ensovibep binds to the SARS-CoV-2 spike protein at three distinct locations to prevent viral entry into cells. “Our preclinical trials with ensovibep have shown that it was able to bind and neutralize SARS-CoV-2 viruses both in vitro and in vivo, including against all currently known mutations of concern,” said Patrick Amstutz, Ph.D., chief executive officer of Molecular Partners. The current trial will aim to see if these results mechanistically translate into clinical efficacy in patients. In a Phase 1 single ascending dose study for safety, tolerability and pharmacokinetics of intravenously administered ensovibep, initial data indicate that ensovibep is well tolerated with a half-life in the range of two to three weeks, which means the concentration of the drug in the body is half of the starting dose after this period of time.
The Swiss Government has reached an agreement with rights to purchase up to 3.2 million doses of ensovibep, if it is approved in Switzerland. The listed biopharma company Molecular Partners, a spin-off from the University of Zurich (UZH), has its headquarters in Bio-Technopark Schlieren-Zurich.