Merck introduced Thursday it will finish the development of its experimental drug for sufferers hospitalized with extreme Covid-19 after the Food and Drug Administration requested the corporate to supply further knowledge to help an emergency use authorization.
New Jersey-based Merck acquired the drug, MK-7110, by means of its $425 million acquisition of privately held biopharmaceutical firm OncoImmune late final yr.
An interim evaluation of scientific trial knowledge instructed the drug improved the probabilities of restoration for the sickest sufferers with Covid-19 and diminished the danger of loss of life or respiratory failure.
However, Merck disclosed in February that U.S. regulators had requested for extra knowledge on the drug past the part three trial already carried out. At the time, the corporate mentioned it not anticipated to provide the U.S. with the drug within the first half of 2021.
Now, on account of “regulatory uncertainties” and the time and assets wanted to supply the extra knowledge, Merck mentioned it determined to discontinue the development of the drug and as a substitute focus its efforts on advancing its different Covid-19 drug in addition to accelerating manufacturing 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 corporate mentioned in a press launch.
The announcement marks one other disappointment for Merck in efforts to fight the pandemic.
In January, it introduced it would end the development of its two Covid-19 vaccines. In early trials, each vaccines generated immune responses that had been inferior to these seen in individuals who had recovered from Covid-19 in addition to these reported for different vaccines, based on the corporate.
While Merck is discontinuing MK-7110, the corporate mentioned it will transfer ahead with its oral antiviral drug, molnupiravir, in a part three scientific trial testing non-hospitalized sufferers with Covid-19.
“We continue to make progress in the clinical development of our antiviral candidate molnupiravir,” Roy Baynes, Merck’s chief medical officer, mentioned in a launch. “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.