Merck & Co. disclosed in its annual report Thursday that the FDA wants to see more data for MK-7110 to support a potential emergency-use application (EUA) for use in patients hospitalised with COVID-19. The company acquired the intravenous immunomodulator, also known as CD24Fc, late last year through its takeover of OncoImmune, which had been running a Phase III trial of the experimental treatment.
Interim findings from the SAC-COVID study released by OncoImmune in September showed a more than 50% reduction in the risk of death or respiratory failure in patients hospitalised with moderate-to-severe COVID-19. The analysis, which was calculated on data from 203 participants, or 75% of the planned enrolment, also indicated that patients treated with a single dose of MK-7110 had a 60% higher chance of improvement in clinical status compared to placebo.
Merck indicated in the annual report that it obtained full data from the study this month and that the findings, which will be submitted for publication, were "consistent with the topline results." The company did not specify what other data the FDA wants to see, but stated that as a result of the agency's feedback, it no longer expects to supply the US government with MK-7110 in the first half of 2021.
According to Merck, the FDA provided its feedback after the company inked a deal in December to supply the US government with about 60,000 to 100,000 doses of MK-7110 by the end of June 2021. As part of that agreement, Merck was going to receive up to $356 million for the manufacture and initial US supply of those doses to help meet the government's pandemic response goals.
Earlier this year, Merck had said it would focus its COVID-19 efforts on both MK-7110 as well as MK-4482, an oral antiviral candidate it is co-developing with Ridgeback Bio, after lacklustre study results prompted it to shutter its coronavirus vaccine programme. Initial results from a trial of MK-4482, also known as molnupiravir and as EIDD-2801, are due as early as the first quarter. Meanwhile, despite ending its vaccine development for COVID-19, Merck recently said it was in talks to help other companies produce their candidates.
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