Novartis and Molecular Partners have announced the start of their EMPATHY Phase II/III study to explore the use of its DARPin (designed ankyrin repeat proteins) therapeutic candidate ensovibep (MP0420) for the treatment of COVID-19. Novartis reportedly will run the trial program, with Molecular Partners serving as sponsor.
The EMPATHY clinical trial program is intended to investigate the safety and efficacy of ensovibep in COVID-19 in the early stages of infection, with the goal of worsening symptoms and hospitalization. According to the companies, the study will enroll 400 patients in Phase II to determine a dose with optimal safety and activity; initial results are expected in August 2021.
Next, Phase III reportedly will proceed with 1,700 patients, with results expected in 2022. If these trial results end up showing promise, Novartis could seek expedited approval for the treatment, through the US Food and Drug Administration’s (FDA’s) emergency use authorization (EUA) program.
Patients eligible for the EMPATHY trial are adults (over 18) who have received a positive antigen test. Additionally, eligible patients should be experiencing a minimum of two predetermined mild or moderate symptoms of the virus within a week of diagnosis.
Lutz Hegemann, group head of corporate affairs and global health with Novartis, said the trial is part of the company’s larger efforts to find effective treatments for the virus behind the global pandemic.
“Novartis remains unwavering in our efforts to help combat COVID-19, including our support to deliver treatment options for patients around the globe,” Hegemann said. “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.”