Drug maker Merck announced early results from the phase 3 clinical trials of its experimental oral drug, molnupiravir, that reduced the risk of hospitalisations and deaths from Covid-19 by about 50 per cent.
At the recommendation of an independent data monitoring committee, the clinical trial was stopped early because the results were so promising. The company, along with its partner Ridgeback Biotherapeutics, is planning to seek US FDA emergency use authorisation for the pill as soon as possible and to submit applications to regulatory bodies worldwide.
“With the virus continuing to circulate widely, and because therapeutic options currently available are infused and/or require access to a health care facility, antiviral treatments that can be taken at home to keep people with Covid-19 out of the hospital are critically needed,”said Wendy Holman, chief executive officer of Ridgeback Biotherapeutics.
Molnupiravir works by blocking the virus’s ability to copy its genetic code and replicate itself. If approved, it would be the first oral antiviral medication for Covid-19. All other available treatment options approved in the US require an infusion or injection given at hospitals or clinics. A pill that can be taken at home could be a game-changer in the fight against the pandemic.
The analysis included 775 non-hospitalised patients with mild-to-moderate Covid-19 from around the world, who were considered high risk for severe disease because of other health conditions such as obesity, diabetes or heart disease. None of the participants were vaccinated.
They were randomised to either take the pill or a placebo twice a day for five days, within five days of onset of Covid-19 symptoms.
Of the patients who received the placebo, 14.1 per cent were either hospitalised or died within 29 days of their treatment compared with 7.3 per cent of those who took molnupiravir. More importantly, no deaths were reported in patients who received molnupiravir compared with eight deaths in patients who received the placebo.
“With these compelling results, we are optimistic that molnupiravir can become an important medicine as part of the global effort to fight the pandemic,”said Merck CEO and president Robert Davis.
“Additionally, based on the participants with available viral sequencing data (approximately 40 per cent of participants), molnupiravir demonstrated consistent efficacy across viral variants Gamma, Delta, and Mu,”Merck said in a statement.
Side effects were comparable across both groups. But Merck did not provide details.
Molnupiravir is also being studied in a phase 3 trial, “which is evaluating the efficacy and safety of molnupiravir in preventing the spread of Covid-19 within households”.
Other companies, including Pfizer and Roche, are also working on similar antiviral pills, the results of which are expected in the next few months.
The trial results released by Merck have not yet been peer reviewed.