Less than a month after it approved for clinical trial approval, Hyderabad-based Natco Pharma said it has begun dosing patients in its phase III clinical trial for molnupiravir, a promising candidate for treating COVID-19 that is being studied across the world. Phase III trial data can be submitted to regulatory agencies for seeking approval of a drug.
The drug was developed by Drug Innovation Ventures (DRIVE), a nonprofit biotech company affiliated with Emory University in Atlanta, and was being studied as a treatment for flu in 2019.
When the COVID-19 pandemic emerged, the scientists decided to focus on exploring the use of molnupiravir against the new virus. DRIVE formed a partnership and transferred the molecule to US-based Ridgeback BioTherapeutics in January 2020.
Ridgeback conducted a Phase I study to evaluate the drug’s safety profile, which yielded positive results.
Thanks to the encouraging results, Ridgeback was able to rope in Merck as a partner to conduct a Phase II study.
That phase II study found that the drug was able to disrupt the virus’ replication process early in the infection cycle. At 5 days follow-up, no infectious virus could be grown from nose swabs taken from participants who received molnupiravir. In comparison, 24% of participants who received placebo still had infectious virus on nose swabs at day 5, according to a statement at the time.
However, later, Merck said it will explore the drug only for people with early/mild symptoms. Quoting an interim analysis, Merck said the drug may not be of much help to “hospitalized patients.”
Merck also said the drug has not shown any indications of causing mutations in the host (human) cells. A related drug, EIDD-1931/NHC, which was earlier explored for use against viruses by Emory scientists, had been abandoned due to such concerns.
These drugs work by introducing mutations in the viruses RNA — the chemical compound that forms the ‘code’ for building the virus. The RNA is so corrupted by the drug that the virus is unable to replicate.
As a result, when given in early stages, the drug is expected to significantly arrest the speed of the replication of the virus as well as its spread from one person to another.
A positive attribute of the drug is that it works very fast, and shows results within 24 hours. It is also given orally, unlike remdesivir, which is given via injections.
Natco said the first patient in its Phase III study was dosed at Yashoda Hospitals in Hyderabad.
“Phase-III clinical trial is initiated to evaluate the efficacy and safety of Molnupiravir Capsules in mild COVID-19 patients. NATCO’s clinical trial is planned in 32 hospitals across India. A few established hospitals locally include Yashoda Hospitals, Gleneagles Global Hospitals, KIMS Hospital in Secunderabad and Vizag, and Excel Hospital, where the trial is being conducted,” the company said.
Merck had, on April 27, announced a tie-up with several Indian generic drug manufacturers for molnupiravir, pointing out that it will “help to accelerate access to molnupiravir in India and around the world”.