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.”
Patrick Amstutz, CEO of Molecular Partners, said the drug at the center of the EMPATHY trial has shown promise to date.
“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,” Amstutz said. “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.”
The companies report initial findings from ensovibep’s Phase I trial indicated the drug is 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 reportedly 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.
Novartis is one of the industry companies scheduled to present on the Innovation Stage at BIO Digital, taking place online June 10-11 and June 14-18, 2021. For more information, visit BIO.org.
