Merck and Ridgeback Biotherapeutics Announce Initiation of Pivotal Phase 3 MOVe-AHEAD Study Evaluating Molnupiravir for Post-Exposure Prophylaxis of COVID-19 Infection

Study Now Enrolling Participants Who sleep in an equivalent Household as Someone With Symptomatic, Laboratory-Confirmed COVID-19

Merck ,known as MSD outside the us and Canada, and Ridgeback Biotherapeutics announced today the initiation of the Phase 3 MOVe-AHEAD clinical test to guage molnupiravir, an investigational oral antiviral therapeutic, for the prevention of COVID-19 infection. the worldwide study is enrolling individuals who are a minimum of 18 years aged and reside within the same household as someone with laboratory-confirmed SARS-CoV-2 infection with symptoms. For more information on the molnupiravir MOVe-AHEAD clinical test , visit http://merckcovidresearch.com/move-ahead/ or www.clinicaltrials.gov.

“As the pandemic continues to evolve and surges are being reported in many places round the world, it’s important that we investigate new ways to guard individuals exposed to the virus from becoming infected with symptomatic disease,” said Dr. Nick Kartsonis, senior vice chairman , vaccines and infectious diseases, clinical research, Merck Research Laboratories. “If successful, molnupiravir could provide a crucial additional option towards reducing the burden of COVID-19 on our communities.”

The safety and efficacy of molnupiravir is additionally currently being evaluated partially 2 of the continued MOVe-OUT trial, which may be a global Phase 3, randomized, placebo-controlled, double-blind, multi-site study of non-hospitalized adult patients with laboratory-confirmed mild to moderate COVID-19 and a minimum of one risk factor related to poor disease outcomes. Data from the study is predicted within the last half of 2021.

MOVe-AHEAD Study

MOVe-AHEAD (MK-4482-013) (NCT04939428) may be a Phase 3 multicenter, randomized, double-blind, placebo-controlled study to guage the efficacy and safety of orally administered molnupiravir compared to placebo in preventing the spread of SARS-CoV-2, the virus that causes COVID-19, within households. The trial will enroll approximately 1,332 participants who are going to be randomized to receive either molnupiravir (800 mg) or placebo orally every 12 hours for five days. The study will enroll participants who are a minimum of 18 years aged and currently residing within the same household with someone who received a positive test for SARS-CoV-2, has a minimum of one sign or symptom of COVID-19 and has not had those signs and symptoms for quite five days. Participants aren’t eligible for the trial if they need received the primary dose of a COVID-19 vaccine quite seven days before enrollment, have previously had COVID-19 or are showing any signs or symptoms of COVID-19.

The primary endpoints of the trial include percentage of participants with COVID-19 (laboratory-confirmed SARS-CoV-2 infection with symptoms) through Day 14, percentage of participants with an adverse event and percentage of participants who discontinued study intervention thanks to an adverse event.

The trial is being conducted globally in countries including Argentina, Brazil, Colombia, France, Guatemala, Hungary, Japan, Mexico, Peru, Philippines, Romania, Russia, South Africa , Spain, Turkey, Ukraine, and therefore the us .

About Molnupiravir

Molnupiravir (MK-4482/EIDD-2801) is an investigational, orally administered sort of a potent ribonucleoside analog that inhibits the replication of multiple RNA viruses including SARS-CoV-2, the causative agent of COVID-19. Molnupiravir has been shown to move in several preclinical models of SARS-CoV-2, including for prophylaxis, treatment, and prevention of transmission, also as SARS-CoV-1 and MERS. Molnupiravir was invented at Drug Innovations at Emory (DRIVE), LLC, a not-for-profit biotechnology company wholly owned by Emory University and is being developed by Merck & Co., Inc. together with Ridgeback Biotherapeutics. Since licensed by Ridgeback, all funds used for the event of molnupiravir are provided by Wayne and Wendy Holman and Merck.

About Ridgeback Biotherapeutics

Headquartered in Miami, Florida, Ridgeback Biotherapeutics LP may be a biotechnology company focused on emerging infectious diseases. Ridgeback markets EbangaTM for the treatment of Ebola and features a late-stage development pipeline which incorporates molnupiravir for the treatment of COVID-19. Development of molnupiravir is entirely funded by Ridgeback Biotherapeutics and Merck & Co., Inc. All equity capital in Ridgeback Biotherapeutics, LP originated from Wayne and Wendy Holman, who are committed to investing in and supporting medical technologies which will save lives. The team at Ridgeback is devoted to working toward finding life-saving and life-changing solutions for patients and diseases that require champions.

About Merck

For over 130 years, Merck, referred to as MSD outside of the us and Canada, has been inventing for all times , bringing forward medicines and vaccines for several of the world’s most challenging diseases in pursuit of our mission to save lots of and improve lives. We demonstrate our commitment to patients and population health by increasing access to health care through far-reaching policies, programs and partnerships. Today, Merck continues to be at the forefront of research to stop and treat diseases that threaten people and animals – including cancer, infectious diseases like HIV and Ebola, and emerging animal diseases – as we aspire to be the premier research-intensive biopharmaceutical company within the world.

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