A New Jersey-based pharmaceutical company says it has developed a pill that reduces the risk of hospitalization or death from COVID-19 by 50%.
Merck announced Friday, Oct. 1, that its Phase 3 clinical trials for the pill, known as molnupiravir, have shown positive early results. The company plans to submit an application the to the U.S. Food and Drug Administration “as soon as possible.”
“More tools and treatments are urgently needed to fight the COVID-19 pandemic, which has become a leading cause of death and continues to profoundly affect patients, families, and societies and strain health care systems all around the world,” said Merck CEO Robert Davis in a prepared statement.
“With these compelling results, we are optimistic that molnupiravir can become an important medicine as part of the global effort to fight the pandemic and will add to Merck’s unique legacy of bringing forward breakthroughs in infectious diseases when they are needed most.”
The drug, taken orally, is meant to inhibit the replication of SARS-CoV-2
Interim trial results showed that out of the 385 symptomatic COVID patients who received the pill, only 28 -- or 7.3% -- were hospitalized within 29 days of receiving the experimental medicine. That was compared to 14.1% of the 377 patients who received a placebo.
Additionally, eight patients who received the placebo died of COVID-19, compared to zero patients who received molnupiravir.
All enrolled patients were required to have at least one risk factor associated with poor disease outcome from coronavirus infection. Molnupiravir’s effectiveness was seen across all key subgroups, Merck said, and the drug demonstrated consistent efficacy across the gamma, delta and mu variants.
The incidence of drug-related adverse events (12%) was comparable to those events reported by the placebo group (11%). Fewer individuals discontinued study therapy due to an adverse event in the drug group (1.3%) compared to the placebo group (3.4%).
Merck said it was on its way to enrolling 1,550 patients in the study, but stopped recruitment based on “the compelling interim efficacy results.” In addition to submitting its data to the FDA, the company plans to submit marketing applications to other regulatory bodies around the world.
The pharmaceutical company says it expects to produce 10 million courses of treatment by the end of 2021, with more doses to come in 2022. Merck agreed to supply the U.S. government with 1.7 million courses upon approval by the FDA.
If granted any level of authorization from the FDA, Molnupiravir could be the first oral antiviral medicine available for COVID-19.
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