Pharmaceutical major Merck and Ridgeback Biotherapeutics announced via a press release on October 1 the early results from Phase-3 trials that its anti-viral drug.
Placebo trials involve testing a drug on thousands of people, in which some of them get the drug and some — who are in a placebo group — do not. In the placebo arm, 53 patients of 14% were either hospitalised or had died, whereas in the group that got the drug, 28 — or 7.3% — were hospitalised or succumbed to the infection.
After 29 days of monitoring, no deaths were reported in patients who received molnupiravir, as compared to eight deaths in those who received placebo.
Several noted clinicians have said that these are promising results, and what is particularly encouraging is that molnupiravir is a pill, unlike other drugs — with similar efficacy — used in COVID-19 treatment, which needs to be administered intravenously.
Gilead Sciences, the makers of Remdesivir, too have recently reported better data, compared to last year, on the efficacy of their treatment in mild to moderate COVID-19 patients, but it continues to be an intravenous medicine.
Is molnupiravir a breakthrough for COVID-19 treatment?
While the hospitalisation-avoidance rates are reassuring, there is still much that is unknown about molnupiravir. Complete phase-3 trial data is pending, a publication in a peer-reviewed medical journal is awaited that will explain the process of the trial in the degree of detail that will inspire more confidence among practitioners and drug authorities everywhere.
The company will soon be submitting data to the United States Food and Drugs Administration for a review, after which the drug may be approved for emergency use authorisation. So far, it being a drug that can be administered as pills as part of a five-day regimen is its biggest strength.
The drug has so far been tested only in patients with mild-to-moderate COVID-19, had started treatment within five days of testing positive and had at least one risk factor that increased their risk for severe disease. These include obesity, older age (>60 years), diabetes mellitus and heart disease.
