MIAMI & KENILWORTH, NJ – (AFTERNOON PRAYER) – Merck (NYSE: MRK), also known as MSD outside the United States and Canada, and Ridgeback Biotherapeutics, LP today announced preliminary results from a randomized, double-blind, placebo-controlled trial at Ridgeback to evaluate the safety, tolerability, and efficacy of SARS-CoV-2 viral RNA elimination of molnupiravir (EIDD-2801 / MK-4482), an orally administered antiviral agent. The companies today reported results on one secondary goal from a Phase 2a study, showing a reduction in time (days) to neglect of infectious virus isolation in nasopharyngeal swabs from participants with SARS- infection. Symptomatic CoV-2, as confirmed by isolation in Vero cell line culture. The first results were presented today at Science SpotlightsTM at the 2021 Conference on Retroviruses and Equine Diseases (CROI 2021). Results from the main points of efficacy and safety and additional key objectives will be presented at an upcoming medical meeting.
The U.S. Phase 2a multicenter study enrolled 202 non-hospital adults with signs or symptoms of COVID-19 within 7 days and confirmed active SARS-CoV-2 infection. The main efficacy goal was a reduction in time to viral negativity measured by polymerase chain transversease (RT-PCR) analysis of nasopharyngeal swabs. Periodic samples were collected for virologic examination. Of the 182 participants with an assessed nasopharyngeal swab, 42% (78/182) showed levels of cultured virus at baseline. The full results of the study are still blind and will be shared later, when available. Other Stage 2 and Stage 2/3 inspections are ongoing.
Today’s presentation described results from the secondary end of the reduction in time (days) to negativity of infectious virus isolation in nasopharyngeal swabs from participants with typical SARS-CoV-2 infection, as confirmed with loneliness in Vero cell line culture. At day 5, there was a decrease (named p = 0.001, no control for proliferation) in advanced viral culture in subjects who received molnupiravir (all doses) compared with placebo: 0% (0/47) for molnupiravir and 24% (6/25) for placebo.
Out of 202 participants treated, no safety symptoms were identified and of the 4 reported adverse events, none were considered a drug study. In addition to the ongoing clinical studies, Merck has conducted an extensive noninvasive program to identify the safety profile of molnupiravir. This program included evaluations such as Big Blue and PIG-a designed to provide a robust measure of a drug’s or chemical ability to induce mutations in vivo. Animals were administered molnupiravir for a longer period of time and at higher doses (mg / Kg) than those employed in human studies. The completeness of the data from these studies indicates the absence of mutagenic or genotoxic molnupiravir in vivo mammal systems.
“We are delighted to share our initial Stage 2 infection data at this important conference, which is still at the forefront of vital clinical scientific information in infectious diseases, ”said Dr Wendy Painter, Chief Medical Officer. Ridgeback Biotherapeutics. “At a time when the need for antiviral therapies against SARS-CoV-2 is not being met, we are encouraged by these preliminary data. ”
“The results of secondary goals in this study, of a more rapid reduction in infectious virus among people with early COVID-19 treated with molnupiravir, are promising and if supported by further studies, may have a significant effect. public health, particularly as the SARS-CoV-2 virus continues to spread and grow globally, ”said Dr William Fischer, lead investigator of the EIDD study -2801 2003 and Associate Professor of Medicine, Department of Pulmonary Diseases and Critical Care Medicine at the University of North Carolina School of Medicine.
“We continue to make progress in our Phase 2/3 clinical programs evaluating molnupiravir in both patient and hospital settings and expect to provide updates where appropriate, ”he said. Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories.
Molnupiravir (EIDD-2801 / MK-4482) is a probiotic, oral bioavailable form of a potent ribonucleoside analog that inhibits RNA multivirus reproduction including SARS-CoV-2, the causative agent COVID-19. Molnupiravir has been shown to be active in several modalities of SARS-CoV-2, including for prophylaxis, treatment, and transmission inhibition, as well as SARS-CoV-1 and MERS. EIDD-2801 was created at Emory’s Drug Innovations (DRIVE), LLC, a nonprofit biotechnology company wholly owned by Emory University. Since being licensed by Ridgeback all funds used for the development of EIDD-2801 by Ridgeback have been donated by Wayne and Wendy Holman and Merck.
About Ridgeback Biotherapeutics
Headquartered in Miami, Florida, Ridgeback Biotherapeutics LP is a biotechnology company focused on emerging infectious diseases. Ridgeback markets EbangaTM for the treatment of Ebola and has a late development pipeline that includes molnupiravir for the treatment of COVID-19. Molnupiravir development is fully funded by Ridgeback Biotherapeutics and Merck & Co., Inc. All equity capital came from Ridgeback Biotherapeutics, an LP from Wayne and Wendy Holman, who are committed to investing in and supporting life-saving medical technologies. The team at Ridgeback is dedicated to working towards finding life-saving and life-changing solutions for patients and diseases that require heroes.
For 130 years, Merck, known as MSD outside the United States and Canada, has been planning for life, advancing medicines and vaccines for many of the world’s most challenging diseases to our mission is to save and promote life. We demonstrate our commitment to patient and population health by increasing access to healthcare through broad policies, programs and partnerships. Today, Merck remains at the forefront of research into the prevention and treatment of diseases that threaten humans and animals – including cancer, infectious diseases such as HIV and Ebola, and emerging animal diseases. crop – and we aim to be the leading research-intensive biopharmaceutical company. in the world. For more information, visit www.merck.com and connect with us on it Twitter, Facebook, Instagram, YouTube and LinkedIn.
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