Interim Results from Phase 2/3 Studies of Molnupiravir, an ... Interim Results from Phase 2/3 Studies of Molnupiravir, an ... Recent data from a phase 2 trial with Molnupiravir showed a reduction in the time required to reach negative isolation of infectious virus from nasopharyngeal swabs from participants with symptomatic SARS-CoV-2 infection. The drug was nearing the end of Phase 3 enrollment . Methods Eligible participants included outpatients with confirmed SARS-CoV-2 infection and symptom onset within 7 days. Interim Results from Phase 2/3 Studies of Molnupiravir, an ... It, therefore, exerts its antiviral function through the introduction of copying errors during viral RNA replication. Molnupiravir is also being evaluated for post-exposure prophylaxis in MOVe-AHEAD, a global, multicenter, randomized, double-blind, placebo-controlled Phase 3 study, which is evaluating the . Preliminary Phase IIa trial results of molnupiravir in ... 10,23,24 On the basis of exposure-response analyses from phase 2 trials, an 800-mg dose of molnupiravir was selected for further . Molnupiravir therapy in unvaccinated COVID-19 patients with mild to moderate disease results in a halving of the rate of hospitalisation. rapidly reduced viral load and decreased medically-attended visits in the phase 1/2 portion of . The US drug company Merck, known in the UK as MSD, later became a partner and . We report the results of a Phase 2a trial evaluating the safety, tolerability, and antiviral efficacy of molnupiravir in the treatment of COVID-19 ( ClinicalTrials.gov NCT04405570 ). Molnupiravir demonstrated activity in preclinical models of SARS-CoV-2, SARS-CoV-1 and MERS, including prophylaxis, cure and transmission prevention. Actual Study Start Date : October 19, 2020: Estimated Primary Completion Date : May 5, 2022: Estimated Study Completion Date : May 5, 2022 Lagevrio (molnupiravir, MK-4482, EIDD-2801) is an antiviral capsule that has been used successfully in studies to treat mild to moderate COVID-19, reducing risk of hospitalization and death.. A recent update of the MOVe-OUT study molnupiravir showed a relative risk reduction of 30% for hospitalization or death, and the relative risk reduction death was 89%, when molnupiravir compared to placebo. Results from the trial were also recently presented at the European Congress of Clinical Microbiology and Infectious Diseases (ECCMID). The Phase 2 portion of the trial enrolled 304 participants randomized 1:1:1:1 to who received molnupiravir 200 mg, 400 mg, 800 mg or placebo twice daily for 5 days. Molnupiravir was evaluated in MOVe-OUT, a global Phase 3, randomized, placebo-controlled, double-blind, multi-site study of non-hospitalized adult patients with symptomatic, laboratory-confirmed mild to moderate COVID-19 and at least one risk factor associated with poor disease outcomes. The data were presented during the late-breaking clinical trials session . The full study results remain blinded and will be shared at a later date, as they become available. Interim Results from Phase 2/3 Studies of Molnupiravir, an Investigational Oral Antiviral Therapeutic for Mild to Moderate COVID-19, Presented at the European Congress of Clinical Microbiology . The data were The data were presented during the late-breaking clinical trials session . Results: Two phase 1 double-blind, randomized, placebo-controlled (DBRPC) studies of molnupiravir showed that 1600 mg daily dose is safe and tolerable, without any serious adverse events up to 5.5 days. The incidence of any adverse event was comparable in the molnupiravir and placebo groups (30.4% and 33.0%, respectively). Also Molnupiravir has been reported to inhibit SARS-CoV-2 infection in vitro and in vivo. 11-10-2021. Article TGA progresses application for MSD's molnupiravir in COVID-19. The company said it has submitted the data to the Indian drugs regulator Drugs . Two phase 1 double-blind, randomized, placebo-controlled (DBRPC) studies of molnupiravir showed that 1600 mg daily dose is safe and tolerable, without any serious adverse events up to 5.5 days. This is a re-analysis of the data from Molnupiravir trials, presented by the FDA. The efficacy of molnupiravir was evaluated in a double-blind, randomized, placebo-controlled, Phase 2 dose-range finding study using realtime polymerase chain reaction (RT-PCR) and virus isolation was conducted at 11 study sites in the U.S. Data are now available from all enrolled participants (n=1433). Interim Results from Phase 2/3 Studies of Molnupiravir, an Investigational Oral Antiviral Therapeutic for Mild to Moderate COVID-19, Presented at the European Congress of Clinical Microbiology & Infectious Diseases (ECCMID) - read this article along with other careers information, tips and advice on BioSpace A new Covid-19 therapy has completed its phase two human trial and the results are promising. "There remains a great need for a range of solutions for the pandemic . It has been shown to block SARS-CoV-2 transmission in ferrets and results of a phase 2/3 clinical trial look promising, leading to a request for emergency use authorization. Phase 2a randomized, placebo-controlled, double-blinded clinical trial of EIDD-2801 in adult men and women who have tested positive for severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2) infection within 144 hours of polymerase chain reaction (PCR) confirmation and are hospitalized with a diagnosis of COVID-19. Molnupiravir was evaluated in several phase 1 and 2 trials. KENILWORTH, N.J. & MIAMI-(BUSINESS WIRE) July 12, 2021 — Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Ridgeback Biotherapeutics announced today the presentation of previously announced Phase 2 interim results from two Phase 2/3 clinical trials (MOVe-OUT and MOVe-IN) of molnupiravir (MK-4482/EIDD-2801), an investigational oral antiviral therapeutic. Methods Eligible participants included outpatients with confirmed SARS-CoV-2 infection and symptom onset within 7 days. Article Merck files with FDA for emergency use of molnupiravir in at risk COVID-19 adults. Hetero Announces Interim Clinical Results from Phase III Clinical Trials of Molnupiravir conducted in India. Merck and Ridgeback Biotherapeutics announced preliminary results from Ridgeback's Phase 2a randomized, double-blinded, placebo-controlled trial to evaluate the safety, tolerability, and efficacy to eliminate SARS-CoV-2 viral RNA of molnupiravir (EIDD-2801/MK-4482), an investigational oral antiviral agent. Here, we report the results of a first-in-human, phase 1, randomized, double-blind, placebo-controlled study to determine the safety, tolerability, and pharmacokinetics of single and multiple ascending oral doses of molnupiravir in healthy subjects. Of the 182 participants with an evaluable nasopharyngeal swab, 42% (78/182) showed detectable levels of cultured virus at baseline. The trials' sponsor modified the pre-registered protocol, so the results will appear more beneficial than they are. Last week Merck announced interim results of a phase 3 clinical trial of molnupiravir. Results Of 103 volunteers screened, 18 participants were enrolled between 17 July and 30 October 2020. Molnupiravir Results Thus Far. The incidence of treatment-associated adverse events was lowest in the molnupiravir 800 mg group. Todos Medical (OTCMKTS: TOMDF) today announced excellent Phase 1/2 results that appear to take dying from COVID-19 off the table. Methods: Eligible participants included outpatients with confirmed SARS-CoV-2 infection and symptom onset within 7 days. Hyderabad: Hyderabad-based Optimus Pharma's interim results of phase III clinical trials for orally administered Molnupiravir capsules on patients with mild Covid-19 patients showed reduced viral load and 78.3 per cent efficacy. 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 . The Phase 2 portion of the trial enrolled 304 participants randomized 1:1:1:1 to who received molnupiravir 200 mg, 400 mg, 800 mg or placebo twice daily for 5 days. One phase 2 DBPRC study found significantly lower time to clearance (RNA negativity) with molnupiravir 800 mg twice daily compared to the . These facts are grounds for a strongly worded rejection of Molnupiravir. The use of molnupiravir therapy within 5 days of the onset of COVID-19 symptoms, produced a 50% reduction in the risk of hospitalisation for any cause or death among unvaccinated patients. In a small clinical trial of 32 patients the company tested Tollovir in hospitalized patients. This briefing document summarize s the overall and subgroup efficacy results from the phase 2/3 clinical trial, Trial MK . 11-08-2021. Periodic samples were collected for virologic analysis. 18-10-2021. Molnupiravir was evaluated in MOVe-OUT, a global Phase 3, randomized, placebo-controlled, double-blind, multi-site study of non-hospitalized adult patients with symptomatic, laboratory-confirmed mild to moderate COVID-19 and at least one risk factor associated with poor disease outcomes. ~ Phase 3 Trial Demonstrates Statistically Significant fewer hospital admissions, Faster Time to Clinical Improvement and early negative SARS CoV-2 RT PCR with Molnupiravir Treatment in Mild COVID 19 Patients Article CSIR-IICT and Suven link up on COVID-19 drugs . Objectives: AGILE is a Phase Ib/IIa platform for rapidly evaluating COVID-19 treatments. We report the results of a Phase 2a trial evaluating the safety, tolerability, and antiviral efficacy of molnupiravir in the treatment of COVID-19 ( ClinicalTrials.gov NCT04405570 ). Participants were randomized 1:1 to 200 mg . Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Ridgeback Biotherapeutics announced today the presentation of previously announced Phase 2 interim results from two Phase 2/3 clinical trials (MOVe-OUT and MOVe-IN) of molnupiravir (MK-4482/EIDD-2801), an investigational oral antiviral therapeutic. Angélica Jayk Bernal, M.D., from IMAT Oncomédica in Monteria, Colombia, and colleagues conducted a phase 3, double-blind, randomized trial to examine the efficacy and safety of molnupiravir . A Phase 2/3, Randomized, Placebo-Controlled, Double-Blind Clinical Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of MK-4482 in Hospitalized Adults With COVID-19: Actual Study Start Date : October 19, 2020: Actual Primary Completion Date : August 11, 2021: Actual Study Completion Date : August 11, 2021 Results. Merck and Ridgeback Biotherapeutics have reported preliminary results from a Phase IIa trial of investigational oral antiviral agent molnupiravir EIDD-2801/MK-4482 for Covid-19. Molnupiravir, developed by Ridgeback Biotherapeutics LP and Merck & Co., reached its endpoint . Billy Fischer, MD. Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Ridgeback Biotherapeutics announced today the presentation of previously announced Phase 2 interim results from two Phase 2/3 clinical trials (MOVe-OUT and MOVe-IN) of molnupiravir (MK-4482/EIDD-2801), an investigational oral antiviral therapeutic. Molnupiravir was evaluated in MOVe-OUT, a global Phase 3, randomized, placebo-controlled, double-blind, multi-site study of non-hospitalized adult patients with symptomatic, laboratory-confirmed . Results Molnupiravir can be generically manufactured at the very low per-course cost of $9.00. "We continue to make progress in our Phase 2/3 clinical programs evaluating molnupiravir in both outpatient and hospital settings and plan to provide updates when appropriate," said Dr. Roy Baynes . The primary efficacy endpoint was to evaluate the efficacy of molnupiravir compared to placebo as assessed by the rate of sustained recovery from randomization through Day 29. An orally-bioavailable form of a potent ribonucleoside analogue, molnupiravir hinders multiple RNA virus replication, including SARS-CoV-2. "These data are promising, and we are pleased to be able to present the Phase 2 interim results for molnupiravir while we proceed with the Phase 3 portion of MOVe-OUT in non-hospitalized patients," said Wendy Holman, chief executive officer, Ridgeback Biotherapeutics. KENILWORTH, N.J. & MIAMI, December 17, /3BLMedia/ - Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Ridgeback Biotherapeutics 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. A non-peer-reviewed phase 2 study results published on June 17, 2021, found Molnupiravir and placebo were associated with few, and mainly low-grade, adverse events. Molnupiravir therapy in unvaccinated COVID-19 patients with mild to moderate disease results in a halving of the rate of hospitalisation. As in previous trials, no safety concerns with molnupiravir were identified in the phase 3 study. Methods: MOVe-OUT is a Phase 2/3, randomized, placebo-controlled, double-blind trial evaluating the safety, efficacy, and pharmacokinetics of MOV in non-hospitalized adults. Participants were randomized 1:1 to 200 mg . Molnupiravir (Formerly MK-4482 and EIDD-2801) is an orally bioavailable prodrug of the synthetic nucleoside derivative N4-hydroxycytidine. In this study population, molnupiravir reduced the risk of hospitalization or death from 9 . Phase-II clinical trial results showed that all patients who received Molnupiravir capsules had a negative SARS-CoV-2 culture after the 5-day treatment duration. Molnupiravir is one of several antiviral drugs under evaluation either for preventing COVID-19 or for treating those who had tested positive. A recently published article described the safety, tolerability, and pharmacokinetic profile of molnupiravir (Painter et al. Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for Merck's molnupiravir for the treatment of mild-to-moderate coronavirus disease (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 . The Molnupiravir's potential to rapidly create to more dangerous variants of SARS-COV-2 has already caught attention of the mainstream media2. Participants were randomized if they had signs or symptoms of COVID-19 within 7 days, and a positive SARS . The incidence of any adverse event was comparable in the molnupiravir and placebo groups (30.4% and 33.0%, respectively). In addition, there was no evidence of a pattern of clinically meaningful abnormalities in laboratory test results. 4.3.2.5. . Molnupiravir damages bone marrow just when it is needed most - to produce B-cells producing antibodies against SARS-COV-2. In addition, there was no evidence of a pattern of clinically meaningful abnormalities in laboratory test results. Interim Results from Phase 2/3 Studies of Molnupiravir, an Investigational Oral Antiviral Therapeutic for Mild to Moderate COVID-19, Presented at the European Congress of Clinical Microbiology . The use of molnupiravir therapy within 5 days of the onset of COVID-19 symptoms, produced a 50% reduction in the risk of hospitalisation for any cause or death among unvaccinated patients. Phase 2 portion of the trial enrolled 304 participants randomized 1:1:1:1 to who received molnupiravir 200 mg, 400 mg, 800 mg or placebo twice daily for 5 days. Here, we report an unprecedented collaboration between sponsor, contract research . MIAMI--(BUSINESS WIRE)--Ridgeback Biotherapeutics, LP today announced the publication of results from its first-in-human Phase 1 study of molnupiravir (EIDD-2801/MK-4482) in healthy volunteers.The . Abstract. Merck reported in MOVe-OUT is an ongoing Phase 2/3, randomized, placebo-controlled, double-blind, multi-site study evaluating the efficacy, safety, and pharmacokinetics of orally administered Molnupiravir in non-hospitalized participants with COVID-19 confirmed using polymerase chain reaction. In March 2021, the companies reported preliminary results from a Phase IIa trial of molnupiravir for Covid-19. Hyderabad: Hetero's interim results from phase 3 trial of Molnupiravir demonstrated statistically significant fewer hospital admissions, faster time to clinical improvement and early negative SARS CoV-2 RT PCR with treatment in mild Covid-19 patients compared to standard of care (SOC) alone, the company said. Merck Pharmaceuticals and Ridgeback Biotherapeutics have announced that their investigational oral therapeutic for the treatment of mild-to-moderate COVID-19, molnupiravir, has showed promising results as part of their phase 2/3 trial.. KENILWORTH, N.J. & MIAMI--(BUSINESS WIRE) July 12, 2021 -- Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Ridgeback Biotherapeutics announced today the presentation of previously announced Phase 2 interim results from two Phase 2/3 clinical trials (MOVe-OUT and MOVe-IN) of molnupiravir (MK-4482/EIDD-2801), an investigational oral antiviral therapeutic. Can be cited as: Goldstein L., Re-analysis of Molnupiravir Trials, Phase II/III; defyccc.com, PREPRINT, [link], 2021. Molnupiravir (MOV) is an orally administered small molecule ribonucleoside prodrug that has been shown to inhibit replication of SARS-CoV-2. Molnupiravir - >>> Interim Results from Phase 2/3 Studies of Molnupiravir, an Investigational Oral Antiviral Therapeutic for Mild to Moderate COVID-19, Presented at the European Congress of Clinical Microbiology & Infectious Diseases (ECCMID) Merck July 12, 2021 After molnupiravir administration, EIDD-1931 was rapidly detected in plasma, with a median time to the peak of 1.00-1.75 h, and thereafter decreased with a geometric t 1/2 of about 1 h, along with a significantly slower removal phase after higher single or multiple doses . SILVER SPRING, Md., Dec. 23, 2021 /PRNewswire/ -- Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for Merck & Co. molnupiravir for the treatment of mild-to-moderate coronavirus disease (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 . As in previous trials, no safety concerns with molnupiravir were identified in the phase 3 study. Published: 21st Jul 2021 2:10 pm. U.S. drugmaker Merck & Co Inc said on Saturday the experimental antiviral drug molnupiravir it is developing with Ridgeback Bio showed a quicker reduction in infectious virus in its phase 2a study . The primary ecacy endpoint was to evaluate the ecacy of molnupiravir compared to placebo as assessed by the rate of sustained recovery from randomization through Day 29. KENILWORTH, N.J. & MIAMI, July 12, 2021--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Ridgeback Biotherapeutics announced today the presentation of previously announced Phase 2 interim results from two Phase 2/3 clinical trials (MOVe-OUT and MOVe-IN) of molnupiravir (MK-4482/EIDD-2801), an investigational oral antiviral therapeutic. KENILWORTH, N.J. & MIAMI--(BUSINESS WIRE)--Merck & Co.(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. 2021), a novel antiviral agent with potent activity against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the causative agent of coronavirus disease 2019 (COVID-19). - Advertisement -. Although the treated group was small Tollovir performed very well and had zero deaths in the treated cohort versus 5 which represented a 23% mortality rate in that population. The ability of molnupiravir to fight Sars-CoV-2, which causes the disease Covid-19, began to be studied in early 2020. The mean maximum detected concentration, as well as area under the . No amino acid substitutions in SARS-CoV-2 associated with resistance to NHC have been identified in Phase 2 clinical trials evaluating molnupiravir for the treatment of COVID-19. Article Fiocruz to participate in Phase III of the molnupiravir study in COVID-19. The company found the drug significantly reduced the risk of hospitalisation . Results of the clinical trial. Molnupiravir was well tolerated at 400, 600 or 800mg doses with no serious or severe adverse events. Supply: In anticipation of the results from MOVe-OUT and the potential for regulatory authorization or approval, Merck has been producing molnupiravir at risk and expects to produce 10 million . Importantly, it has already been shown to demonstrate its antiviral effects against SARS-CoV-2 in vitro, and against the related SARS-CoV-1 . KENILWORTH, N.J. & MIAMI, July 12, 2021--Interim Results from Phase 2/3 Studies of Molnupiravir, Investigational Oral Antiviral Therapeutic for Mild to Moderate COVID-19, Presented at ECCMID A Phase 2/3, Randomized, Placebo-Controlled, Double-Blind Clinical Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of MK-4482 in Non-Hospitalized Adults With COVID-19. We report the results of a Phase 2a trial evaluating the safety, tolerability, and antiviral efficacy of molnupiravir in the treatment of COVID-19 ( ClinicalTrials.gov NCT04405570). Issue #6 Effect of Molnupiravir on SARS -CoV-2 Spike Protein . In this trial (NCT04746183) we evaluated the safety and optimal dose of molnupiravir in participants with early symptomatic infection.Methods: We undertook a dose-escalating, open-label, randomized-controlled (standard-of-care) Bayesian adaptive Phase I trial at the Royal Liverpool and Broadgreen Clinical . Other Phase 2 and Phase 2/3 studies are underway. 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