Merck has had a torrid time with COVID-19 vaccines and a major setback with its OncoImmune-partnered pandemic med, but now, finally, it’s seeing some good news on that R&D front.
Over the weekend, the Big Pharma and its biotech partner Ridgeback announced their drug, molnupiravir, hit one of its secondary objectives from a new trial, namely to reduce time to negativity of infectious SARS-CoV-2 virus isolation from swabs in patients with symptomatic COVID-19.
The data show that, at Day 5, there was a reduction in positive viral culture in subjects who received molnupiravir (all doses) compared to placebo: 0% (0/47) for molnupiravir and 24% (6/25) for placebo.
Merck said no safety signals were seen, and, “of the 4 serious adverse events reported, none were considered to be study drug related.”
These early findings from a phase 2a test of around 200 non-hospitalized patients were presented during Science Spotlights at the 2021 Conference on Retroviruses and Opportunistic Infections (CROI).
This is just a peek, with primary endpoints and more secondaries “to be presented at an upcoming medical meeting,” which will show a much clearer picture of how well this drug may be working.
Still, this is good news for Merck and its partner, especially for the Big Pharma, which had to throw out a vaccine program after it failed to work and has been beset by woe for its other partnered COVID-19 drug with OncoImmune, which the FDA has said needs another trial (though we don’t know exactly why).
Molnupiravir (formerly EIDD-2801) works as an oral nucleoside analog that has shown broad-spectrum activity against RNA viruses, including influenza and coronaviruses like SARS and MERS.
Ridgeback licensed the pill last March from Emory University’s nonprofit biotech company, Drug Innovations at Emory, or DRIVE. At the time, DRIVE was prepping it for clinical trials in influenza, but it “immediately recognized” its potential for treating COVID-19. Merck then signed up with the biotech to help boost tests, which started last summer.
“The secondary objective findings in this study, of a quicker decrease in infectious virus among individuals with early COVID-19 treated with molnupiravir, are promising and if supported by additional studies, could have important public health implications, particularly as the SARS-CoV-2 virus continues to spread and evolve globally,” said William Fischer, M.D., lead investigator of the EIDD-2801 2003 study and associate professor of medicine in the division of pulmonary diseases and critical care medicine at the University of North Carolina School of Medicine.
“We continue to make progress in our phase 2/3 clinical programs evaluating molnupiravir in both outpatient and hospital settings and plan to provide updates when appropriate,” added Roy Baynes, M.D., Ph.D., senior vice president, head of global clinical development and chief medical officer at Merck Research Laboratories.
Data from the phase 2/3 pivotal studies of the med are expected this quarter.
Analysts at Cantor said the positive data “show promise for Merck’s COVID treatment,” adding: “We believe the secondary findings in this study of a quicker decrease in infectious virus among individuals with early COVID-19, treated with molnupiravir, are promising and support the additional studies that Merck is running.”