[ad_1]
MIAMI AND KENILWORTH, NJ – (BUSINESS WIRE) – Merck (NYSE: MRK), known as MSD outside of the United States and Canada, and Ridgeback Biotherapeutics, LP today announced preliminary results from the randomized, double-blind, Phase 2a trial , placebo controlled by Ridgeback to assess the safety, tolerability, and efficacy in eliminating SARS-CoV-2 viral RNA from molnupiravir (EIDD-2801 / MK-4482), an investigational oral antiviral. The companies today reported results on a secondary objective of the Phase 2a study, showing a reduction in the negativity time (days) of infectious virus isolation from nasopharyngeal swabs of participants with symptomatic infection with SARS-CoV-2, as determined by isolation from cultured Vero cells in line. These preliminary results were presented today at Science SpotlightsTM at the 2021 Conference on Retroviruses and Opportunistic Infections (CROI 2021). The results of the main efficacy and safety parameters and additional secondary objectives will be presented at a future medical meeting.
This US phase 2a multicenter study enrolled 202 outpatient adults who exhibited signs or symptoms of COVID-19 within 7 days and who confirmed active SARS-CoV-2 infection. The main efficacy objective was to reduce the time to viral negativity measured by reverse transcriptase polymerase chain reaction (RT-PCR) analysis of nasopharyngeal swabs. Periodic samples were collected for virological analysis. Of the 182 participants with an evaluable nasopharyngeal swab, 42% (78/182) showed detectable levels of virus in culture at baseline. Full study results remain blind and will be shared at a later date as they become available. Other phase 2 and phase 2/3 studies are underway.
Today’s presentation described the results of the secondary endpoint of reduction of time (days) to negativity of isolating infectious virus from nasopharyngeal swabs of participants with symptomatic SARS-CoV-2 infection, such as determined by isolation in culture of the Vero cell line. On day 5, there was a reduction (nominal p = 0.001, uncontrolled for multiplicity) in positive viral culture in subjects who received molnupiravir (all doses) compared to placebo: 0% (0/47) for molnupiravir and 24% (6/25) for placebo.
Of 202 participants treated, no safety signal was identified and of the 4 serious adverse events reported, none were considered to be related to the study drug. In addition to ongoing clinical studies, Merck has conducted a comprehensive non-clinical program to characterize the safety profile of molnupiravir. This program included tests such as Big Blue and PIG-a designed to provide a robust measure of the ability of a drug or chemical to induce mutations. in vivo. Animals received molnupiravir for longer and at higher doses (mg / kg) than those used in human studies. All the data from these studies indicate that molnupiravir is neither mutagenic nor genotoxic in in vivo mammalian systems.
“We are very excited to share our Phase 2 infectivity data at this important conference, which remains at the forefront of critical clinical scientific information on infectious diseases, ”said Dr. Wendy Painter, Chief Medical Officer of Ridgeback Biotherapeutics. “At a time when the need for antiviral treatments for SARS-CoV-2 is unmet, we are encouraged by these preliminary data.
“The secondary objective results of this study, of a more rapid decrease in infectious virus in people with early-onset COVID-19 treated with molnupiravir, are promising and, if supported by additional studies, could have important implications for public health, especially due to SARS-CoV-2 The virus continues to spread and evolve globally, ”noted Dr. William Fischer, principal investigator of the 2003 EIDD-2801 study. and Associate Professor of Medicine, Division of Lung Disease and Critical Care, University of North Carolina School of Medicine.
“We continue to make progress in our Phase 2/3 clinical programs evaluating molnupiravir in both outpatient and inpatient settings and plan to provide updates as appropriate, ”said Dr. Roy Baynes, Senior Vice President and Chief Global Clinical Development, Medical Director, Merck Research Laboratories.
About molnupiravir
Molnupiravir (EIDD-2801 / MK-4482) is an experimental orally bioavailable form of a potent ribonucleoside analogue that inhibits the replication of several RNA viruses, including SARS-CoV-2, the causative agent of COVID-19. Molnupiravir has been shown to be active in several models of SARS-CoV-2, including for the prophylaxis, treatment and prevention of transmission, as well as SARS-CoV-1 and MERS. EIDD-2801 was invented at Drug Innovations at Emory (DRIVE), LLC, a not-for-profit biotechnology company 100% owned by Emory University. Since the Ridgeback license, all funds used for the development of EIDD-2801 by Ridgeback have been provided by Wayne and Wendy Holman and Merck.
About Ridgeback Biotherapeutics
Based in Miami, Florida, Ridgeback Biotherapeutics LP is a biotechnology company specializing in emerging infectious diseases. Ridgeback markets EbangaTM for the treatment of Ebola and has an advanced development pipeline that includes molnupiravir for the treatment of COVID-19. The development of molnupiravir is fully funded by Ridgeback Biotherapeutics and Merck & Co., Inc. All equity in Ridgeback Biotherapeutics, LP comes from Wayne and Wendy Holman, who are committed to investing and supporting life-saving medical technologies. . The Ridgeback team is dedicated to finding life-saving and life-changing solutions for patients and diseases that need champions.
About Merck
For 130 years, Merck, known as MSD outside of the United States and Canada, has been inventing for life, providing drugs and vaccines for many of the world’s most difficult diseases as part of our mission to save and improve lives. We demonstrate our commitment to patients and the health of the population by improving access to health care through broad policies, programs and partnerships. Today, Merck continues to be at the forefront of research to prevent and treat diseases that threaten people and animals – including cancer, infectious diseases such as HIV and Ebola, and emerging animal diseases. – as we aspire to be the leading research-intensive biopharmaceutical company. in the world. For more information, visit www.merck.com and connect with us on Twitter, Facebook, Instagram, YouTube and LinkedIn.
Forward-looking statement by Merck & Co., Inc., Kenilworth, NJ, United States
This press release from Merck & Co., Inc., Kenilworth, NJ, USA (the “Company”) contains “forward-looking statements” within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. These statements are based on the current beliefs and expectations of the management of the company and are subject to significant risks and uncertainties. There can be no assurance with respect to pipeline products that the products will receive the necessary regulatory approvals or prove to be commercially successful.. If the underlying assumptions prove to be incorrect or if risks or uncertainties materialize, actual results may differ materially from those stated in forward-looking statements.
Risks and uncertainties include, but are not limited to, general industry conditions and competition; general economic factors, including fluctuations in interest rates and exchange rates; the impact of the global novel coronavirus disease (COVID-19) epidemic; the impact of pharmaceutical industry regulation and health care legislation in the United States and globally; global trends towards containing health care costs; technological advances, new products and patents obtained by competitors; challenges inherent in developing new products, including obtaining regulatory approval; the company’s ability to accurately forecast future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of company patents and other protections for innovative products; and exposure to litigation, including patent litigation, and / or regulatory actions.
The company assumes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in forward-looking statements can be found in the Company’s 2020 Annual Report on Form 10-K and in other documents filed by the Company with the Securities and Exchange Commission (SEC) available from the SEC. Website (www.sec.gov).
[ad_2]
Source link
