Molecular Partners, Novartis Say Covid-19 Drug Ensovibep Meets Goals In Phase 2 Study

(RTTNews) - Molecular Partners AG (MOLN) and Novartis announced positive data from phase 2 study for Ensovibep (MP0420), a DARPin Antiviral Therapeutic for COVID-19.

A total of 407 patients were recruited in the Phase 2 study and ensovibep was safe and well-tolerated at all doses (75mg, 225mg and 600mg) - with 75mg the planned dose for further development, Molecular said in a statement.

The results from the randomized, placebo-controlled EMPATHY Part A study in acute COVID-19 ambulatory patients comparing single intravenous doses of ensovibep vs. placebo, met the primary endpoint of viral load reduction over eight days, for all three dosing arms.

The secondary endpoint of hospitalization and/or ER visits related to COVID-19, or death showed an overall 78% reduction in risk of events across ensovibep arms compared to placebo. Treatment arms were generally balanced in terms of demographic, baseline and disease characteristics.

The placebo arm with 99 patients had a total of six events (event rate of 6%); five patients were hospitalized, two of whom died due to worsening of COVID-19 and one patient had an ER visit only.

In the 301 patients treated with ensovibep, there were four events; hospitalizations occurred in two patients and two needed to visit ER (event rate of 1.3%). No deaths occurred in any of the patients treated with ensovibep.

Novartis has informed Molecular Partners of its intent to option its exclusive license to global rights of ensovibep, which will lead to a milestone payment of CHF 150 million. In addition, Molecular Partners will be eligible to receive 22% royalty on sales.

Molecular Partners expects about CHF 133 million cash and cash equivalents as per December 31, 2021. Upon receipt of the CHF 150 million option exercise milestone from Novartis, Molecular Partners now estimates its cash runway to extend well into 2025, excluding any potential royalty income as well as excluding potential further cash flows to or from R&D partners.