Molecular Partners Reports Continued Progress of Ensovibep Global Clinical Program; Positive in vitro Data Demonstrating Maintained Inhibition of Delta and All Other Known Variants of Concern of SARS-CoV-2
ZURICH-SCHLIEREN, Switzerland, July 08, 2021 (GLOBE NEWSWIRE) — 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 reported on the clinical progress of its novel antiviral candidate, ensovibep, as part of a presentation with its partner Novartis at the 1st Credit Suisse ESG Forum Switzerland virtual event. Ensovibep is designed to bind and inhibit SARS-CoV-2, the virus that causes COVID-19. Ensovibep is currently being studied in a Phase 2 single-arm pilot study in ambulatory patients in the Netherlands; a global Phase 2/3 study in ambulatory patients, conducted in collaboration with Novartis (EMPATHY); and a National Institutes of Health (NIH)-sponsored global Phase 3 study in hospitalized patients as part of the ACTIV-3 master protocol.
During today’s presentation, management outlined initiation of a subcutaneous program to align with the global registrational studies presently underway using administration via infusion. Initiating this year, the studies will evaluate ensovibep delivered subcutaneously to healthy individuals and subsequently to COVID-19 patients. Subcutaneous administration may increase ease and speed of administration to complement ensovibep’s simple, high yield manufacturing process, stability, and potential inhibition of all major viral variants to-date.
“The need for antiviral treatment that is active against all viral variants emerging globally continues to be critical, especially in a context of mixed vaccination rates,” said Patrick Amstutz, Ph.D., chief executive officer of Molecular Partners. “We continue to be encouraged by the in vitro data seen for ensovibep against all known viral variants of concern. As we and Novartis continue to open additional clinical sites in multiple countries, data such as these suggest we can offer a truly differentiated solution to patients in need.”
The EMPATHY study is presently enrolling across 5 countries, with continued expansion expected into additional territories as the evolving pandemic dictates. The ACTIV-3 study is presently enrolling patients in the hospitalized setting for assessment with ensovibep across more than 50 centers in 4 countries. The ACTIV-3 study protocol is open for recruitment in the hospitalized setting across 120 centers presently with more centers to open in the coming months. The program is aimed to be active in countries where the virus has high case numbers and to cover emerging variants on a global level.
Finally, and in parallel to the clinical progress updated today, ensovibep continues to be evaluated for its potency and inhibition against all emerging and established variants of concern. These evaluations are conducted across multiple laboratories, including the NIH. In vitro data to date show that ensovibep retains full potency and viral inhibition against all known SARS-CoV-2 variants in circulation, including the key Delta variants containing the T478K and K417N mutations, presently a particular concern as it may be associated with higher infectivity rates, even in individuals who are vaccinated.