Novartis and Molecular Partners announced the start of the clinical trial EMPATHY, a Phase 2 and 3 study, to explore the use of its novel DARPin therapeutic candidate ensovibep (MP0420) for the treatment of COVID-19. Novartis will conduct the clinical trial program for ensovibep, with Molecular Partners as sponsor of the studies. In March 2021, Molecular Partners reported positive initial Phase 1 results in healthy volunteers.
The EMPATHY clinical trial program is investigating the safety and efficacy of ensovibep in patients with COVID-19, who are in the early stages of infection, to prevent worsening symptoms and hospitalization. The study will enroll 400 patients in Phase 2 to identify a dose with optimal safety and activity, with initial results anticipated in August 2021. At that point Phase 3 will move ahead with an additional 1,700 patients with results anticipated in H1 2022. If the initial EMPATHY trial results are convincing, this would pave the way for Novartis to seek expedited approval via the FDA’s Emergency Use Authorization (EUA).
Those eligible for the EMPATHY trial are adults, over the age of 18, with a positive SARS-CoV-2 antigen test and who are experiencing at least two pre-determined mild/moderate symptoms of COVID-19 within 7 days of their diagnosis.
“Novartis remains unwavering in our efforts to help combat COVID-19, including our support to deliver treatment options for patients around the globe,” said Dr. Lutz Hegemann, Group Head, Corporate Affairs and Global Health, Novartis. “Today, with Molecular Partners, we’re announcing an important next step in the development of ensovibep, which holds promise to respond to breakthrough disease and new variants in the future. We are hopeful the results of this clinical trial program will provide a reliable treatment option for patients with COVID-19.”
Novartis believes a multi-solution strategy is needed to overcome COVID-19, one that utilizes a range of diagnostic and therapeutic options, depending on the needs of individual patients. Every country should have access to effective medicines to treat COVID-19 and despite availability of vaccinations, there continues to be disease transmission and there is likely to continue to be breakthrough disease.
“By virtue of its tri-specific design, ensovibep was built to resist viral mutations and indeed shows potent inhibition of all variants of concern to date, with the potential to maintain activity also for future variants. This type of broad spectrum activity is essential for any treatment of relevance for patients with COVID-19,” said Patrick Amstutz, Chief Executive Officer, Molecular Partners. “Reaching this important clinical milestone is not only a key step to combat this virus, but also validating our DARPin approach to generate multispecific antiviral therapies in the fight against global pandemics.”
Initial findings from the Phase 1 trial of ensovibep showed it to be safe and well tolerated with no significant adverse events. Predictable exposure was seen post-administration, confirming the expected half-life of two to three weeks. These data confirmed the systemic administration of a multi-specific DARPin antiviral therapy to be safe and well tolerated and support plans for additional clinical work in patients diagnosed with COVID-19, as part of the EMPATHY trial. The preclinical work for MP0423 is still ongoing and is being led by Molecular Partners.