Merck Calls It Quits on Oral COVID-19 Treatment

Merck has decided to end research and development on MK-7110, an experimental oral drug for treatment of hospitalized coronavirus patients that had shown promise in a late-stage trial.

The pharma titan said Thursday that it would drop its efforts on the drug — which it obtained through a $425 million acquisition of OncoImmune in November 2020 — after the FDA said it would need to see additional data beyond OncoImmune’s study to potentially grant Emergency Use Authorization (EUA). Merck had said in March that it would launch a phase 3 trial for the drug (DID, March 4) but has now said the study will not go ahead.

“Based on the additional research that would be required — new clinical trials as well as research related to manufacturing at scale — MK-7110 would not be expected to become available until the first half of 2022,” Merck said.

The drug had shown promise in a phase 3 study in September of last year, and Merck had gone as far as signing a 100,000-dose supply contract with the U.S. government for $356 million (DID, Dec. 28, 2020). But the drugmaker, citing “technical, clinical and regulatory uncertainties” as well as the availability of other drugs for hospitalized COVID-19 patients, said it would now focus its efforts on developing its experimental coronavirus antiviral molnupiravir and on manufacturing J&J’s COVID-19 vaccine.

Merck and partner Ridgeback Biotherapeutics also announced Thursday that they will not advance to a phase 3 trial of hospitalized COVID-19 patients for their oral antiviral molnupiravir but will go ahead with a late-stage trial that evaluates it as a treatment for nonhospitalized patients.

Merck previously discontinued development of its two coronavirus vaccine hopefuls in January after phase 1 trial findings demonstrated lackluster immune responses. The move came as a shock considering the company’s strong reputation for developing vaccines (DID, Jan. 26). — James Miessler