Hetero finds positive results from Molnupiravir third phase trials

Representative image: Reuters

Hetero, a Hyderabad-headquartered pharmaceutical firm, has announced that it has found positive results from the Phase-III trials of Molnupiravir, an investigational oral antiviral COVID-19 drug.

In a statement on February 19, the drugmaker said the trials showed that Molnupiravir reduced the risk of hospitalisation by over 65 percent compared to standard of care medication alone.

The company said the early viral clearance (negative RT-PCR) and significant clinical improvement were observed within five days of administering the antiviral drug and that no fatalities were reported during the study.

Hetero has presented the results of Phase-III trials of Movfor (Molnupiravir) as an oral abstract at the Conference on Retroviruses and Opportunistic Infections (CROI) held virtually during February 12-16.

It is among the few Indian generic drug firms that had entered into a non-exclusive voluntary licensing agreement with the US-based innovator Merck Sharp & Dohme Corp (MSD) in April 2021 for the manufacturing and distribution of investigational oral therapeutic antiviral drug Molnupiravir for the treatment of COVID-19.

Other Indian generic firms that inked non-exclusive voluntary licensing deals with MSD include Natco, Lupin, Laurus, MSN, Strides, Biophore, SMS Pharma, Arene Lifesciences, BDR and Optimus.

Hetero was allowed to expand access to Molnupiravir in India and in other low-and middle-income countries, following the approvals for emergency use authorisation by local regulatory agencies.

One of the studies the company carried out included 1,218 COVID-19 patients with symptoms as per the Indian Council of Medical Research (ICMR) guidelines under the Phase-III trials. According to the drugmaker, the study enrolled eligible patients, within five days of symptoms onset, and were administered with Molnupiravir capsules (800 mg twice daily) along with the standard of care (SOC) or SOC alone for five days.

The SOC medication was administered as defined by the ICMR in its guidelines for COVID-19 patients, published at the time of the study, said Hetero.

The 27-year-old company is engaged in research and development, manufacturing, and marketing of chemical and biologic medicines. The strategic business areas of Hetero are spread across active pharmaceutical ingredients, global generics, biosimilars and custom pharmaceutical services.