Ensovibep has met the primary endpoint of viral load reduction over 8 days in a phase 2 study, the companies said.
Novartis and Molecular Partners said that Part A of the EMPATHY clinical trial that compared single intravenous doses of ensovibep, a DARPin antiviral therapeutic candidate to treat COVID-19, with a placebo met its primary endpoint of viral load reduction over 8 days, Novartis said in a statement.
The 2 secondary endpoints, composite endpoint of emergency department (ED) visits and/or hospitalization or death and time to sustained clinical recovery, also showed clinically meaningful benefit compared with the placebo.
Novartis said that it will exercise its option to in-license ensovibep from Molecular Partners and will seek expedited access globally, first via the FDA’s emergency use authorization process.
The global EMPATHY trial was a double-blind, placebo-controlled, randomized study in 407 non-hospitalized individuals from Hungary, India, the Netherlands, South Africa, and the United States. The trial explored 3 doses of ensovibep: 75, 225, and 600 mg.
Results from the study showed that the primary endpoints were met with statistically significant reduction in viral load over 8 days compared with the placebo for all 3 dosing arms.
The secondary endpoint of ED visits and/or hospitalization related to COVID-19 or death showed an overall 78% reduction in risk of events across the ensovibep arms compared with the placebo.
The treatment arms were generally well balanced with baseline, demographic, and disease characteristics.
The placebo arm with 99 individuals had a total of 6 events: 5 were hospitalized, 2 of whom died because of worsening of COVID-19, and 1 individual had an ED visit only. In the 301 individuals treated with ensovibep, there were 4 events: 2 individuals were hospitalized and 2 visited the ED.
No deaths occurred in any of the individuals treated with ensovibep.
All doses were well-tolerated, and no unexpected safety issues were identified for any of the doses. The lowest dose of 75 mg is the planned dose for further development.
The data will undergo further review so that Novartis and Molecular Partners can determine the appropriate next steps for the program.
“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,” Vas Narasimhan, CEO of Novartis, said in the statement. “As COVID-19 continues to burden health care 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.”.
With the decision to exercise the option, Novartis will be responsible for development, manufacturing, distribution, and commercialization activities of ensovibep. Novartis has already initiated scale-up activities in its large-scale biologics production facilities.
“Today’s data are a culmination of a persistent team effort, between ourselves and Novartis, to deliver a tailored antiviral with demonstrated safety and efficacy in global clinical trials. As pioneers of DARPin therapeutics, our team has the unique ability to rapidly generate and develop multi-specific DARPin therapeutics,” Patrick Amstutz, PhD, CEO of Molecular Partners, said in the statement.
“We look forward to continue to demonstrate our capabilities and the potential of our pipeline in oncology, virology and for patients in need,” he said.
Novartis and Molecular Partners report positive topline data from Phase 2 study for ensovibep (MP0420), a DARPin antiviral therapeutic for COVID-19. Novartis. News release. January 10, 2022. Accessed January 11, 2022. https://www.novartis.com/news/media-releases/novartis-and-molecular-partners-report-positive-topline-data-from-phase-2-study-ensovibep-mp0420-darpin-antiviral-therapeutic-covid-19