Novartis and Molecular Partners have announced the launch of a global phase 2/3 study for their novel COVID-19 therapeutic candidate ensovibep – also known as MP0420.
In October 2020, Novartis announced its collaboration with Molecular Partners, which included access to two anti-COVID-19 drugs, ensovibep and MP0423.
Both of these therapeutics – referred to as DARPin candidates – are designed to target a number of different sites on the SARS-CoV-2 virus simultaneously, with the aim of enhancing antiviral effects.
They have potential use as both prophylactics and treatments for COVID-19, Molecular Partners said in a statement.
Initial positive phase 1 study results found that ensovibep was safe and well tolerated, with no significant adverse events reported.
Preliminary results also found that extended exposure to the therapeutic in serum with a half-life of two to three weeks was ‘as expected’ from preclinical testing.
The newly launched phase 2/3 EMPATHY trial will explore the use of ensovibep for the treatment of COVID-19 patients who are in the early stages of infection. The study aims determine if the novel drug can prevent symptoms from progressing to severe disease and hospitalisation.
Novartis and Molecular Partners are expecting to enrol 400 patients into the phase 2 stage to identify the optimal dose for safety and activity, with the first results anticipated in August.
Following this, the phase 3 stage will progress with an additional 1,700 patients – the results from this study stage are expected in the first half of 2022.
Novartis will also seek a US Food and Drug Administration (FDA) emergency use authorisation depending on the initial EMPATHY trial results.
“Novartis remains unwavering in our efforts to help combat COVID-19, including our support to deliver treatment options for patients around the globe,” said 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 programme will provide a reliable treatment option for patients with COVID-19,” he added.
While ensovibep is being progressed through mid-stage clinical testing, preclinical work for MP0423 is ongoing and is being led by Molecular Partners.