Merck and Ridgeback Bio Collaborate to Advance Development of Novel Antiviral Candidate, EIDD-2801
Clinical Studies of EIDD-2801 for the Treatment of Patients with COVID-19 are Underway Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Ridgeback Biotherapeutics LP, a closely held biotechnology company, today announced that the companies have entered into a collaboration agreement to develop EIDD-2801, an orally available antiviral candidate currently in early clinical development for the treatment of patients with COVID-19. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200526005229/en/ “In addition to our efforts to develop potential vaccines to SARS-CoV-2, we have also been evaluating our own anti-viral assets and those from external sources for their potential to treat individuals with COVID-19,” said Dr. Roger M. Perlmutter, president, Merck Research Laboratories. “Clinical evaluation of EIDD-2801 in COVID-19 patients is just beginning, now that phase 1 studies have demonstrated that the
https://www.merck.com/news/merck-and-ridgeback-bio-collaborate-to-advance-development-of-novel-antiviral-candidate-eidd-2801/
Population pharmacokinetics of molnupiravir in adults with COVID-19: Lack of clinically important exposure variation across individuals
Effective antiviral treatments for coronavirus disease 2019 (COVID-19) are needed to reduce the morbidity and mortality associated with severe acute respiratory syndrome-coronavirus 2 (SARS-CoV-2) infection, particularly in patients with risk factors for severe disease. Molnupiravir (MK-4482, EIDD-2801) is an orally administered, ribonucleoside prodrug of β-D-N4-hydroxycytidine (NHC) with submicromolar potency against SARS-CoV-2. A population pharmacokinetic (PopPK) analysis for molnupiravir exposure was conducted using 4202 NHC plasma concentrations collected in 1207 individuals from a phase I trial in healthy participants, a phase IIa trial in non-hospitalized participants with COVID-19, a phase II trial in hospitalized participants with COVID-19, and a phase II/III trial in non-hospitalized participants with COVID-19. Molnupiravir pharmacokinetics (PK) was best described by a two-compartment model with a transit-compartment absorption model and linear elimination. Molnupiravir apparent elimination clearance increased with body weight less-than-proportionally (power 0.412) and was estimated as 70.6 L/h in 80-kg individuals with a moderate interindividual variability (43.4% coefficient of variation). Additionally, effects of sex and body mass index on apparent central volume and food status and formulation on the absorption mean transit time were identified as statistically significant descriptors of variability in these PK parameters. However, none of the identified covariate effects caused clinically relevant changes in the area under the NHC concentration versus time curve between doses, the exposure metric most closely related to clinical response. Overall, the PopPK model indicates that molnupiravir can be administered in adults without dose adjustment based on age, sex, body size, food, and mild-to-moderate renal or mild hepatic impairment.© 2023 Merck Sharp & Dohme LLC. Ridgeback Biotherapeutics. Jill Fiedler-Kelly and The Authors. CPT: Pharmacometrics & Systems Pharmacology published by Wiley Periodicals LLC on behalf of American Society for Clinical Pharmacology and Therapeutics.
https://www.merck.com/publication/population-pharmacokinetics-of-molnupiravir-in-adults-with-covid-19-lack-of-clinically-important-exposure-variation-across-individuals/
Merck and Ridgeback’s Molnupiravir, an Investigational Oral Antiviral COVID-19 Treatment, Receives Special Approval for Emergency in Japan
Japan’s Ministry of Health, Labor and Welfare Approves Molnupiravir for the Treatment of SARS-CoV-2 Infection Molnupiravir, First Oral COVID-19 Antiviral Medicine To Receive Authorization in the World, Now Authorized in U.S., U.K. and Japan; Regulatory Submissions Are Under Review Around the World Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Ridgeback Biotherapeutics today announced that Japan’s Ministry of Health, Labor and Welfare has granted Special Approval for Emergency in Japan for molnupiravir, an investigational oral antiviral medicine, for infectious disease caused by SARS-CoV-2. Special Approval for Emergency is the process under Article 14-3 of the Pharmaceuticals and Medical Devices Act to approve a medical product swiftly in an emergency situation to protect public health. Under a previously announced supply agreement, the Japanese government will purchase 1.6 million courses of molnupiravir to accelerate access to patients. This press release
https://www.merck.com/news/merck-and-ridgebacks-molnupiravir-an-investigational-oral-antiviral-covid-19-treatment-receives-special-approval-for-emergency-in-japan/
Merck and Ridgeback’s Molnupiravir Receives U.S. FDA Emergency Use Authorization for the Treatment of High-Risk Adults With Mild to Moderate COVID-19
The Companies Are Committed To Providing Timely Access to Molnupiravir Through Comprehensive Supply and Access Approach Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Ridgeback Biotherapeutics today announced that the U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for molnupiravir, an investigational oral antiviral (MK-4482, EIDD-2801). Molnupiravir has not been approved, but has been authorized for emergency use by the FDA under an EUA to treat mild to moderate coronavirus disease 2019 (COVID-19) in adults with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death, and for whom alternative COVID-19 treatment options authorized by the FDA are not accessible or clinically appropriate. Molnupiravir is not authorized for use in patients who are less than 18 years of age, for initiation of treatment in patients hospitalized due to
https://www.merck.com/news/merck-and-ridgebacks-molnupiravir-receives-u-s-fda-emergency-use-authorization-for-the-treatment-of-high-risk-adults-with-mild-to-moderate-covid-19/
Merck and Ridgeback Announce Publication of Phase 3 Study of Molnupiravir, an Investigational Oral Antiviral COVID-19 Treatment, in the New England Journal of Medicine
Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Ridgeback Biotherapeutics today announced the New England Journal of Medicine has published findings from the Phase 3 MOVe-OUT trial evaluating molnupiravir, an investigational oral antiviral medicine, in non-hospitalized high risk adults with mild to moderate COVID-19. Data from MOVe-OUT demonstrated that early treatment with molnupiravir significantly reduced the risk of hospitalization or death in high risk, unvaccinated adults with COVID-19. Merck is developing molnupiravir in collaboration with Ridgeback Biotherapeutics. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20211216006079/en/ Molnupiravir is authorized in the United Kingdom as the first oral antiviral for the treatment of mild to moderate COVID-19 in adults with a positive SARS-CoV-2 diagnostic test and who have at least one risk factor for developing severe illness. The European
https://www.merck.com/news/merck-and-ridgeback-announce-publication-of-phase-3-study-of-molnupiravir-an-investigational-oral-antiviral-covid-19-treatment-in-the-new-england-journal-of-medicine/
Merck and Ridgeback Statement on Positive FDA Advisory Committee Vote for Investigational Oral Antiviral Molnupiravir for Treatment of Mild to Moderate COVID-19 in High Risk Adults
Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Ridgeback Biotherapeutics today provided the following statement at the conclusion of the U.S. Food and Drug Administration’s (FDA) Antimicrobial Drugs Advisory Committee (AMDAC) regarding the Emergency Use Authorization (EUA) application for molnupiravir (MK-4482, EIDD-2801), an investigational oral antiviral medicine, for the treatment of mild to moderate COVID-19 in adults with positive results of direct SARS-CoV-2 viral testing who are at high risk for progressing to severe COVID-19 and/or hospitalization. The Advisory Committee voted 13-10 that the known and potential benefits of molnupiravir outweigh its known and potential risks for the treatment of mild to moderate COVID-19 in high risk adult patients who are within five days of symptom onset. The FDA is not bound by the committee’s guidance but takes its advice into consideration. This press release features multimedia. View the full release here:
https://www.merck.com/news/merck-and-ridgeback-statement-on-positive-fda-advisory-committee-vote-for-investigational-oral-antiviral-molnupiravir-for-treatment-of-mild-to-moderate-covid-19-in-high-risk-adults/
Merck and Ridgeback Biotherapeutics Provide Update on Results from MOVe-OUT Study of Molnupiravir, an Investigational Oral Antiviral Medicine, in At Risk Adults With Mild-to-Moderate COVID-19
Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Ridgeback Biotherapeutics today provided an update on the MOVe-OUT study of molnupiravir (MK-4482, EIDD-2801), an investigational oral antiviral medicine for COVID-19. Data are now available from all enrolled participants (n=1433). In this study population, molnupiravir reduced the risk of hospitalization or death from 9.7% in the placebo group (68/699) to 6.8% (48/709) in the molnupiravir group, for an absolute risk reduction of 3.0% (95% confidence interval [CI]: 0.1, 5.9; nominal p-value=0.0218) and a relative risk reduction of 30% (relative risk 0.70; 95% CI: 0.49, 0.99). Nine deaths were reported in the placebo group, and one in the molnupiravir group. The adverse event profile for molnupiravir remained consistent with the profile reported at the planned interim analysis. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20211126005279/en/ Based on
https://www.merck.com/news/merck-and-ridgeback-biotherapeutics-provide-update-on-results-from-move-out-study-of-molnupiravir-an-investigational-oral-antiviral-medicine-in-at-risk-adults-with-mild-to-moderate-covid-19/
Merck and Ridgeback to Present Phase 3 Data for Molnupiravir, an Investigational Oral COVID-19 Antiviral Medicine, at American Society of Tropical Medicine and Hygiene (ASTMH) 2021 Annual Meeting
Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Ridgeback Biotherapeutics today announced that new Phase 3 data for molnupiravir, an investigational oral COVID-19 antiviral medicine, will be presented as a late-breaking poster (#LB-5319) at the American Society of Tropical Medicine and Hygiene (ASTMH) 2021 Annual Meeting taking place virtually from Nov. 17-21. Poster data will be available on Wednesday, Nov. 17 at 9 a.m. ET and presented during Poster Session C from 11 a.m.-12:30 p.m. ET on Saturday, Nov. 20. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20211117005607/en/ The presentation will include data from the molnupiravir clinical development program, with an emphasis on the interim results from the MOVe-OUT trial, including baseline characteristics of study population and additional details on efficacy and safety. The companies previously announced positive results from a planned interim
https://www.merck.com/news/merck-and-ridgeback-to-present-phase-3-data-for-molnupiravir-an-investigational-oral-covid-19-antiviral-medicine-at-american-society-of-tropical-medicine-and-hygiene-astmh-2021-annual-meeting/
Merck and Ridgeback Announce Japanese Government to Purchase 1.6 Million Courses of Molnupiravir, an Investigational Oral COVID-19 Antiviral Medicine, Upon Authorization or Approval
Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Ridgeback Biotherapeutics today announced that the Japanese government will purchase, upon authorization or approval, approximately 1.6 million courses of molnupiravir (MK-4482, EIDD-2801), an investigational oral antiviral medicine. Merck is developing molnupiravir in collaboration with Ridgeback Biotherapeutics. Merck’s applications for the potential authorized use of molnupiravir are under review by Japan’s Pharmaceuticals and Medical Devices Agency, the U.S. Food and Drug Administration , and the European Medicines Agency . Molnupiravir is authorized in the United Kingdom for the treatment of mild-to-moderate COVID-19 in adults with a positive SARS-CoV-2 diagnostic test and who have at least one risk factor for developing severe illness. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20211110005792/en/ “We are proud to partner with the Japanese
https://www.merck.com/news/merck-and-ridgeback-announce-japanese-government-to-purchase-1-6-million-courses-of-molnupiravir-an-investigational-oral-covid-19-antiviral-medicine-upon-authorization-or-approval/
Merck and Ridgeback Announce U.S. Government to Purchase 1.4 Million Additional Courses of Molnupiravir, an Investigational Oral Antiviral Medicine, for the Treatment of Mild-to-Moderate COVID-19 in At Risk Adults
Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Ridgeback Biotherapeutics today announced that the United States government will exercise two of its options to purchase a total of 1.4 million additional courses of molnupiravir, an investigational oral antiviral medicine, if the medicine is granted Emergency Use Authorization (EUA) or approval by the U.S. Food and Drug Administration (FDA), for approximately $1 billion. With these exercised options, the U.S. government has now committed to purchase a total of approximately 3.1 million courses of molnupiravir, for approximately $2.2 billion, between authorization and early 2022. The U.S. government also has the ability to purchase more than 2 million additional courses through further options that remain in the contract. Merck is developing molnupiravir in collaboration with Ridgeback Biotherapeutics. This press release features multimedia. View the full release here:
https://www.merck.com/news/merck-and-ridgeback-announce-u-s-government-to-purchase-1-4-million-additional-courses-of-molnupiravir-an-investigational-oral-antiviral-medicine-for-the-treatment-of-mild-to-moderate-covid-19-in-a/