Molecular Partners AG 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 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. Molecular Partners’ Molecular Partners’ two antiviral DARPin® candidates, ensovibep and MP0423, are designed to target multiple different sites on the SARS-CoV-2 virus simultaneously for enhanced antiviral effects and potential use as both COVID-19 prophylaxis and treatment. The benefits of this multi-specificity include cooperative binding, high potencies and potential prevention of viral escape via mutations. The candidates are formatted with a DARPin® domain that binds to human serum albumin (HSA) to support a longer half-life and hence longer activity. All DARPin® candidates are constructed to benefit from high-yield and cost-effective manufacturing. Molecular Partners is investigating whether the high thermal stability of DARPin® molecules can be used to overcome cold-chain requirements. In March 2021, the Company announced positive initial data from its Phase 1 study of ensovibep in healthy volunteers, which showed that ensovibep was safe and well-tolerated with a half-life of 2-3 weeks. In October 2020, Molecular Partners entered into a collaboration with Novartis AG in the form of an option agreement to develop, manufacture and commercialize Molecular Partners’ anti-COVID 19 DARPin® candidates. Per the terms of the agreement, Molecular Partners will conduct Phase 1 clinical trials for ensovibep and perform all remaining preclinical work for MP0423; Novartis will conduct Phase 2 and Phase 3 clinical trials, with Molecular Partners as sponsor of those trials. Upon option exercise, Novartis would be responsible for all further development and commercialization activities. Molecular Partners is also collaborating with AGC Biologics, Baccinex, and Ivers-Lee Clinical Supply Management (IL-CSM) to support development of its anti-COVID-19 program, and has reached an agreement with the Swiss Government regarding rights to purchase up to 3.2 million doses of ensovibep, if it is approved in Switzerland.