Hetero COVID drug Molnupiravir shows positive results in Phase III trials

Hyderabad: Hetero, a globally renowned vertically integrated pharmaceutical organization has recently announced the positive results of Phase III trials of Hetero's Movfor (Molnupiravir), an investigational oral antiviral COVID-19 medicine.

The results, presented as an Oral Abstract at the Conference on Retroviruses and Opportunistic Infections (CROI) held virtually February 12–16, 2022, demonstrated that Molnupiravir along with Standard of Care (SOC) reduced the risk of hospitalization by over 65% compared to SOC alone. Early viral clearance (negative RT-PCR) and significant clinical improvement were observed within 5 days of administering the antiviral drug. There were no fatalities reported during the study. Under the Phase III trials, one of the studies included 1218 COVID-19 patients (with SPO2>93% and COVID-19 symptoms as per ICMR COVID-19 guidelines). The study enrolled eligible patients, within 5 days of symptom onset, and were administered with Molnupiravir capsules (800 mg twice daily) + Standard of Care (SOC) or SOC alone for 5 days.

The standard of care (SOC) medication was administered as defined by the Indian Council of Medical Research (ICMR) in its guidelines for COVID-19 patients, published at the time of study.

Molnupiravir is an investigational, orally bioavailable form of a potent ribonucleoside analog that inhibits the replication of multiple RNA viruses including SARS-CoV2, the causative agent of COVID19. Molnupiravir has been shown to be active in several models of SARS-CoV-2, including for prophylaxis, treatment and prevention of transmission, as well as SARS-CoV-1 and MERS. EIDD-2801 was invented at Drug Innovations at Emory (DRIVE), LLC, a not-for-profit biotechnology company wholly owned by Emory University. Since licensed by Ridgeback, all funds used for the development of EIDD-2801 by Ridgeback have been provided by Wayne and Wendy Holman and MSD.

Hetero entered into a non-exclusive voluntary licensing agreement with MSD in April 2021 for the manufacturing and distribution of investigational oral therapeutic antiviral drug 'Molnupiravir' for the treatment of COVID-19.

Under this licensing deal, Hetero was allowed to expand access of Molnupiravir in India and in other low-and middle-income countries (LMICs), following the approvals for emergency use authorization by local regulatory agencies.

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