Benzinga | Jan 10, 2022 04:49AM EST

Molecular Partners and Novartis Report Topline Data from Phase 2 Study for Ensovibep Show DARPin Antiviral Therapeutic Candidate for COVID-19 vs. Placebo Met Primary Endpoint of Viral Load Reduction over Eight Days

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, and Novartis today announced that Part A of the EMPATHY clinical trial1, that compared single intravenous dosesof ensovibep, a DARPin antiviral therapeutic candidate vs. placebo to treat COVID-19, met the primary endpoint of viral load reduction over eight days. The two secondary endpoints also showed clinically meaningful benefit over placebo (1) composite endpoint of hospitalizationand/orEmergency Room (ER) visitsordeath, and (2) timeto sustained clinical recovery.Novartis confirms it will now exercise itsoption to in-license ensovibep from Molecular Partners and, following exercise of the option, will seek expedited access globally, first via the FDA's EUA process.

The global EMPATHY clinical trial, which is being conducted byNovartis, with Molecular Partners as sponsor, is a randomized,double-blind,placebo controlledstudy in ambulatory (non-hospitalized) adult patients with COVID-19.EMPATHYPart Aenrolled 407 patients to identify a dose of ensovibep with optimal safety and efficacyandrecruited patients in the USA, South Africa, India, theNetherlands,and Hungarytoexplore three doses: 75mg, 225mg and 600mg.

Results fromthestudy showed thattheprimary endpoint was met witha statistically significant reduction in viral loadovereight days, compared to placebo, for all three dosing arms. The secondary endpoint ofhospitalization and/or ER visitsrelated to COVID-19,ordeathshowedan overall78% reductionin risk of events across ensovibep armscompared to placebo.Treatment arms were generally balanced in terms of demographic,baselineand diseasecharacteristics.The placebo arm with 99 patients had a total of six events(event rate of6%);five patients were hospitalized, two of whom died due to worsening of COVID-19andone patient had an ER visitonly. In the 301 patients treated withensovibep, there were four events; hospitalizations occurred in two patientsand two needed to visit ER(event rate of1.3%). No deaths occurred in any of the patients treated with ensovibep. All doses were well-tolerated and no unexpected safety issues were identified for any of the doses2.The lowest dose of 75mg is the planned dose for further development.The data will now undergo further review so that Novartis and Molecular Partners can determine the appropriate next steps for the program.

"Theseencouraging results come at a time whenthe need for therapieswith pan-variant activity, such as ensovibep,has never been greater.We are incredibly excited about the opportunity to provide a potential therapeutic option for patients around the world who require access to effective COVID-19 treatments,"said Patrick Amstutz, Ph.D., CEO of Molecular Partners. "Today's data are a culmination of a persistent team effort,betweenourselvesand Novartis,to deliver a tailored antiviral with demonstrated safety and efficacy in global clinical trials. AspioneersofDARPin therapeutics,ourteam has theuniqueability torapidlygenerateand developmulti-specificDARPintherapeutics.We look forward to continue to demonstrateour capabilities and the potential of our pipeline in oncology and virology for patients in need."

As the SARS-CoV-2 virus evolves, a multi-solution strategy is needed to combat the pandemic and there will be a need for antiviral treatments to complement the global vaccination efforts. Despite availability of vaccinations, there continues to be disease transmission, either through pockets of unvaccinated populations, in patients with compromised immune systems and co-morbidities or through emerging variants, and breakthrough infections are likely tocontinue.A recentin vitroanalysis3also showed that ensovibep maintains full neutralization of thepseudovirusescontainingthe mutationsidentical to the Omicronvariant of concern.

"We are pleased that the results from the EMPATHY trial demonstrate the positive therapeutic effect of ensovibep, with the potential to be an important new treatment option to combat the rapidly evolving SARS-CoV-2 pandemic," said Vas Narasimhan, CEO of Novartis. "As COVID-19 continues to burden healthcare systems across the globe, a range of treatments will be needed, and Novartis is proud to continue our collaboration with Molecular Partners on this unique treatment for COVID-19 and contribute ensovibep to this suite of options."

Given the pressing public health emergency and the rapid spread of the Omicronvariant across the world, Novartis and Molecular Partners are in close liaison with regulatory bodies to seek expedited review and approval of ensovibep as soon as possible.If approved, ensovibep will be the first multi-specific antiviral molecule for the treatment of COVID-19.

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 150m. In addition, Molecular Partners will be eligible to receive 22% royalty on sales. Molecular Partners has agreed to forgo royalties in lower income countries and is aligned with Novartis' plans to ensure affordability based on countries' needs and capabilities. With the decision made to exercise theoption, Novartis will become responsible for development, manufacturing,distributionand commercializationactivitiesof ensovibep.Novartis has already initiatedscale-up activities in its large-scalebiologicsproduction facilities.

Financial guidance updateThe Company expects approximately 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.

Conference call and audio webcastMolecular Partners will hold a conference call and audio webcast on Monday, January 10, 2022, at 7am ET.

To register for the conference call, please dial the following numbers approximately 10 minutes before the start of the presentation:

Switzerland / Europe 0800836508USA (844) 865-3856Conference ID 5090778Participants in the conference call will have the opportunity to ask questions after a statement from management.

Audio webcastThe call will be webcast live and will be madeavailableon the Company's website under the investor section. The replay will be available for 90 days following the presentation. Webcast participants will have the opportunity to ask questions via chat.