Novartis is kick-starting a new trial with Molecular Partners for an experimental COVID-19 drug just a few months after another partnered attempt flopped.
The U.S.-Swiss major was a little late to the COVID-19 R&D game, but has in recent months tried to ramp things up, penning a pandemic vaccine manufacturing pact with Pfizer/BioNTech and CureVac while also pairing with two biotechs on new drugs against the disease.
The first of these partnerships, with Australian cell therapy specialist Mesoblast, hasn’t gone so well: The pair inked a $50 million upfront deal in November last year for global rights to remestemcel-L in COVID-19, reinvigorating a project that had been hit by FDA rejection as a treatment for children with steroid-resistant graft-versus-host disease just a few weeks earlier.
The deal also included $505 million in development milestones and $750 million in sales milestones, plus tiered double-digit royalties. But a month later, a phase 3 test flopped when data experts looked at remestemcel-L in ventilator-dependent patients with moderate to severe acute respiratory distress syndrome due to COVID-19 and said it was unlikely to show a benefit.
This saw Mesoblast’s shares crater, and Novartis looked like it had backed the wrong horse. There’s still a chance that remestemcel-L could show a benefit on some of these other endpoints, and, alongside Novartis, it will keep following up the patient cohort through 60 days to explore that further, with the data expected soon.
Novartis did not, however, put all its eggs in one basket, and also penned a deal with Molecular Partners for a different approach. That $69 million deal was for MP0420 and MP0423, two antivirals out of the biotech’s so-called DARPin tech.
Today, the pair said ensovibep (the new name for MP0420) is “expected to be included in a global phase 3 randomized, controlled clinical trial as part of the National Institutes of Health’s Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) program.”
This trial, ACTIV-3, is set up to assess the safety and efficacy of various therapies for the treatment of adults hospitalized with a COVID-19 diagnosis. This also comes after the National Institutes of Health had to can several other experimental meds from its COVID-19 drug program, including candidates from Eli Lilly, GSK/Vir and Brii Biosciences, after initial data showed they were unlikely to benefit patients.
Should Novartis hit up its option to fully license these meds, it would then be responsible for all further development and sales. The pair will also work together to scale up manufacturing capacity in collaboration with Novartis’ generics and biosimilar biz Sandoz.