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Novartis and Molecular Partners announce start of EMPATHY clinical trial for ensovibep for the treatment of COVID-19.

Read time: 2 mins
Published:28th May 2021
Novartis and Molecular Partners announced the start of the clinical trial EMPATHY, a Phase II and III 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 II to identify a dose with optimal safety and activity, with initial results anticipated in August 2021. At that point Phase III 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 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. Sustained binding against new variants of Covid-19 ; Molecular Partners, in collaboration with academic and government partners, has conducted in vitro experiments using pseudovirion models of SARS-CoV-2 to analyze for infectivity in the presence of ensovibep. These models represent new variants first identified in UK (B1.1.7), South Africa (B.1.351), Brazil (P.1), California (B.1.429), New York (B.1.526), emerging variants R.1 and A.23.1, the individual key mutations of the variants identified in India, B.1.617 and B.1.618, and other key spike mutations identified to date. The results suggest ensovibep continues to retain full potency against the new viral variants of SARS-CoV-2, and could have the potential for sustained binding to additional COVID-19 variants, as they may appear in the future. Ensovibep enrollment in ACTIV-3 trial :Molecular Partners and Novartis also recently announced the inclusion of ensovibep in the NIH-Sponsored ACTIV-3 Trial (National Institute of Health’s (NIH) Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) program) that aims to prioritize and push forward development of the most promising COVID-19 therapies. ACTIV-3 is a global Phase III trial that will investigate the safety and efficacy of ensovibep in adults hospitalized with COVID-19, with an aim to enroll up to 1,000 patients. The first patient dose is expected to be administered in June 2021, with an interim analysis after 300 patients with mild-to-moderate disease. These patients will receive either ensovibep or a placebo. Trial participants will also receive an existing standard of care for COVID-19, including the FDA-approved antiviral remdesivir. If the treatment has a positive risk-benefit profile, the study will enroll an additional 700 patients for further testing. Ensovibep is the first non-antibody therapy assessed in ACTIV-3, supporting a different approach for COVID-19 treatment. The development program will be led by Molecular Partners until Phase 1 is complete and will be handed over to Novartis to conduct the pivotal clinical trial EMPATHY, with Phase II and III trials, with Molecular Partners as sponsor of these trials. Molecular Partners will perform all remaining preclinical work for MP 0423.

Condition: Coronavirus/COVID-19 Infection
Type: drug

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