Merck announced Thursday that it will discontinue 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 a license for use in case of emergency.
New Jersey-based Merck acquired the drug MK-7110 through the acquisition of the private biopharmaceutical company OncoImmune late last year for $ 425 million.
An interim analysis of clinical trial data suggested that the drug improved the chances of recovery for the sick patients with Covid-19 and reduced the risk of death or respiratory failure.
However, Merck announced in February that US regulators had asked for more data on the drug after the already completed phase three study. At the time, the company said it no longer expects to supply the US with the drug in the first half of 2021.
Now, due to “ regulatory uncertainties ” and the time and resources required to provide the additional data, Merck said it decided to halt development of the drug and instead focus its efforts on advancing its another Covid-19 drug and speeding up the production of the Johnson & Johnson vaccine.
“Based on the additional research that would be required – new clinical trials and research related to scale manufacturing – MK-7110 is not expected to be available until the first half of 2022,” the company said in a press release.
The announcement marks another disappointment for Merck in its efforts to combat the pandemic.
In January, it announced it would be ending development of its two Covid-19 vaccines. In early studies, both vaccines generated immune responses inferior to those of people recovered from Covid-19 and reported for other vaccines, the company said.
While Merck is discontinuing the MK-7110, the company said it will continue 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 statement. “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.”
–Reuters contributed to this report.