- The U.S. government will pay Merck & Co. $356 million for between 60,000 and 100,000 doses of an experimental drug being tested as a treatment of gravely ill patients hospitalized with COVID-19. Merck acquired the drug, dubbed MK-7110, in a $425 million buyout of the biotech OncoImmune last month.
- The therapy is designed to tamp down on the body's inflammatory response to coronavirus infections, which can cause complications and death even after virus replication is brought under control. The approach is similar to the thinking behind repurposing anti-inflammatory drugs from Roche, Regeneron and others, although clinical trials of those therapies have failed or produced mixed results.
- The deal announced Wednesday suggests the U.S. government sees a continued need for new drugs for severely sick patients even as it rolls out a mass vaccination program with newly authorized shots from Pfizer and Moderna.
Merck was impressed enough with initial results of MK-7110 to buy OncoImmune last month. Now the U.S. government appears to be similarly convinced.
Developed as an immune-suppressing drug for patients receiving stem cell transplants, MK-7110 was hustled into a Phase 3 study by OncoImmune in April. The trial tested whether treatment with MK-7110 could speed the recovery of hospitalized patients needing oxygen support by more than those receiving regular treatments and a placebo.
The trial stopped recruitment in September after enrolling 270 patients and OncoImmune has reported interim efficacy results showing that treated patients were 60% more likely to recover than those receiving a placebo. Treated patients recovered a median of six days after treatment, compared with 10 days for placebo participants.
In addition, the treatment appeared to have an additive benefit when combined with Gilead's antiviral Veklury or with corticosteroids such as dexamethasone, which have both been shown to help certain patients hospitalized with COVID-19.
Patients who received corticosteroids plus MK-7110, for example, recovered a median of five days after treatment, compared with 15 for those treated with a corticosteroid plus placebo. The company has not disclosed how many patients received combination treatments, however. Full study results are expected to be published in a peer-reviewed medical journal.
MK-7110 is a fusion protein designed to shut off a signaling molecule on antibodies that, when activated, can spur an organ-damaging inflammatory response. That response often comes after white blood cell counts have dropped while fighting off a viral infection.
OncoImmune points to clinical and preclinical data showing its drug can lessen inflammation and restore white blood cell levels as evidence of its biological activity.
Under the deal with the U.S., Merck would deliver doses of MK-7110 through June 30, 2021, as well as expand its production capacity for the drug.
The deal comes at a critical time. COVID-19 cases are likely to continue accumulating rapidly in the U.S. despite the arrival of highly protective vaccines, as both are in short supply. Healthcare workers and residents in long-term healthcare facilities are currently being prioritized for the first supplies.
Merck, one of the world's largest vaccine developers, was slow to get started on coronavirus research. In May, however, the drugmaker bought one company to access an experimental vaccine and partnered with a charity to develop another. Both candidates are now in early-stage testing.
The pharma company also bought rights to an antiviral drug developed by Emory University and licensed by Ridgeback Therapeutics.