Merck announced Thursday it will end the development of its experimental drug for patients hospitalized with severe Covid-19 after the Food and Drug Administration asked the company to provide additional data to support an emergency use authorization.
New Jersey-based Merck acquired the drug, MK-7110, through its $425 million acquisition of privately held biopharmaceutical company OncoImmune late last year.
An interim analysis of clinical trial data suggested the drug improved the chances of recovery for the sickest patients with Covid-19 and reduced the risk of death or respiratory failure.
However, Merck disclosed in February that U.S. regulators had asked for more data on the drug beyond the phase three trial already conducted. At the time, the company said it no longer expected to supply the U.S. with the drug in the first half of 2021.
Now, due to “regulatory uncertainties” and the time and resources needed to provide the additional data, Merck said it decided to discontinue the development of the drug and instead focus its efforts on advancing its other Covid-19 drug as well as accelerating production of the Johnson & Johnson vaccine.
“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,” the company said in a press release.
The announcement marks another disappointment for Merck in efforts to combat the pandemic.
In January, it announced it would end the development of its two Covid-19 vaccines. In early trials, both vaccines generated immune responses that were inferior to those seen in people who had recovered from Covid-19 as well as those reported for other vaccines, according to the company.
While Merck is discontinuing MK-7110, the company said it will move forward with its oral antiviral drug, molnupiravir, in a phase three clinical trial testing non-hospitalized patients with Covid-19.
“We continue to make progress in the clinical development of our antiviral candidate molnupiravir,” Roy Baynes, Merck’s chief medical officer, said in a release. “Data from the dose-finding portion of these studies are consistent with the mechanism of action and provide meaningful evidence for the antiviral potential of the 800 mg dose.”
