Molnupiravir (MK-4482 / EIDD-2801) Antiviral – Precision Vaccinations

Molnupiravir (MK-4482 / EIDD-2801) Antiviral Description

Molnupiravir (MK-4482 / EIDD-2801) is an oral antiviral drug originally developed for the treatment of influenza. MK-4482 / EIDD-2801 consists of the nucleoside analogue N4-hydroxycytidine (NHC). Molnupiravir has been evaluated against coronaviruses (CoVs), including SARS-1, MERS-CoV and SARS-CoV-2.

The drug was originally developed at Emory University by the university’s drug innovation company, Drug Innovation Ventures at Emory (DRIVE). It was later acquired by Ridgeback Biotherapeutics, which works with Merck & Co. to further develop the antiviral agent.

A study published April 29, 2020 found the potential of NHC / EIDD-2801 against multiple CoVs, and oral bioavailability highlights its potential utility as an effective antiviral against SARS-CoV-2 and other future zoonotic CoVs.

On June 19, 2020, Miami-based Ridgeback Biotherapeutics announced the launch of two phase 2 clinical trials to test the efficacy of EIDD-2801 as an antiviral treatment for COVID-19.

Ridgeback Biopharmaceuticals was co-founded by CEO Wendy Holman and Dr. Wayne Holman, a scientific advisor to the company, with an emphasis on developing antiviral drugs for epidemic and pandemic risk diseases.

Molnupiravir (MK-4482 / EIDD-2801) Antiviral indication

Molnupiravir (MK-4482 / EIDD-2801) antiviral agent is indicated to reduce SARS-CoV-2 infection and block its transmission, thereby preventing COVID-19 disease.

Molnupiravir (MK-4482 / EIDD-2801) Antiviral news

December 5, 2020 – Researchers from the Institute of Biomedical Sciences at Georgia State University, led by Dr. Richard Plemper, found that a SARS-CoV-2 infection was treated with a new antiviral drug, MK-4482 / EIDD-2801 or Molnupiravir, completely suppresses virus transmission within 24 hours.

July 7, 2020 – Ridgeback Biotherapeutics announced the start of enrollment in a phase 2 study of possible COVID-19 treatment EIDD-2801. The new trial will be conducted using the new COVID-19 drug testing platform AGILE. AGILE will test multiple potential therapies and EIDD-2801 was selected as the first oral antiviral agent studied in the AGILE platform.

August 1, 2020 – Merck & Co. plans to begin two large clinical trials of an experimental oral antiviral therapy for Covid-19 in September, with efforts to market another treatment option. There is “a great medical need for an orally active treatment,” Roger Perlmutter, the pharmaceutical giant’s top scientist, said Friday at the Merck conference call. The therapy, known as MK-4482.

Molnupiravir (MK-4482 / EIDD-2801) Antiviral Clinical Studies

MK-4482 / EIDD-2801 is currently being tested in several advanced multi-center clinical trials:

Clinical Study NCT04405739: The safety of molnupiravir (EIDD-2801) and its effect on SARS-CoV-2 viral shedding (END-COVID)

Phase 2a randomized, placebo-controlled, double-blind clinical trial with EIDD-2801 in adult men and women who tested positive for severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2) infection (PCR) within 48 hours of polymerase chain reaction and confirmed hospitalized with a diagnosis of COVID-19.

Rapid uptake and treatment will be initiated so that the first dose of EIDD-2801 or placebo will be administered as soon as possible and within 7 days of the onset of symptoms.

Stratified randomization of participants who will receive remdesivir at enrollment and those who will not receive remdesivir at enrollment.

Clinical study NCT04405570: A safety, tolerability and efficacy of molnupiravir (EIDD-2801) to eliminate the detection of infectious viruses in subjects with COVID-19

This is a Phase IIa, double-blind, placebo-controlled, randomized study designed to compare the safety, tolerability and antiviral activity of EIDD-2801 with placebo as measured by detection of infectious virus in symptomatic adult outpatients with COVID-19.

The study is a multicentre study to be conducted in the United States.

In this study, up to about 108 participants will be randomized to receive EIDD-2801 or Placebo twice daily (BID) orally for 5 days. The study may include up to 5 portions with subsequent doses that may be higher or lower than those studied in previous cohorts and will be doses evaluated for safety in a phase 1 study. Doses will be selected based on new virological and safety data from this and ongoing studies.

Clinical Study NCT04575584: Efficacy and Safety of Molnupiravir (MK-4482) in Hospitalized Adult Participants with COVID-19 (MK-4482-001)

This study aims to evaluate the safety, tolerability and efficacy of molnupiravir (MK-4482) compared to placebo. The primary hypothesis is that molnupiravir is superior to placebo as judged by the rate of sustained recovery through Day 29.

Clinical Study NCT04575597: Efficacy and Safety of Molnupiravir (MK-4482) in Non-Hospitalized Adult Participants with COVID-19 (MK-4482-002)

This study aims to evaluate the safety, tolerability and efficacy of molnupiravir (MK-4482) compared to placebo. The primary hypothesis is that molnupiravir is superior to placebo, as judged by the percentage of participants who are hospitalized and / or die through Day 29.

Source link