Pharmaceutical giant Merck and an American laboratory reported promising results Saturday in trials of a drug administered orally to fight COVID-19, saying it helps reduce patients’ viral load.
“At a time where there is unmet need for antiviral treatments against SARS-CoV-2, we are encouraged by these preliminary data,” said Wendy Painter, chief medical officer of the US firm, Ridgeback Biotherapeutics.
In January, Merck halted work on two COVID vaccine candidates but has pressed on with research into two products to treat the disease, including a pill-based one called molnupiravir, which it has developed with Ridgeback Biotherapeutics.
This drug caused a significant drop in patients’ viral load after five days of treatment with it, Merck said at a meeting with infectious disease experts.
This Phase 2a test—drug trials have three stages before a product can be approved—was carried out among 202 non-hospitalized people with symptoms of COVID-19.
There was no alert in terms of safety, and of four serious adverse events that were reported, none were considered to be related to taking this drug, Ridgeback said.
Anti-viral oral drugs such as oseltamivir (Tamiflu) and zanamivir (Relenza) are sometimes prescribed for seasonal flu but researchers have yet to come up with something similar to fight the coronavirus.
The findings of this study—a quicker decrease in viral load among individuals with early-stage COVID-19 who are treated with molnupiravir—are promising, said William Fischer, lead investigator of the study and a professor of medicine at the University of North Carolina.
“If supported by additional studies, (they) could have important public health implications, particularly as the SARS-CoV-2 virus continues to spread and evolve globally,” Fischer added.
Merck is also working on another oral COVID treatment called MK-711.
Preliminary results from clinical trials with it show a more than 50 percent reduction in risk of death or respiratory trouble in patients hospitalized with moderate to severe COVID-19, the company said in January.
Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced it has entered into an agreement with the United States Government to support the development, manufacture and initial distribution of an investigational biological therapeutic (CD24Fc, to be named MK-7110) upon approval or Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA). Merck acquired MK-7110 through the acquisition of OncoImmune, a privately held, clinical-stage biopharmaceutical company.
“Building upon the promising clinical findings to date for MK-7110, Merck is pleased to be collaborating with the U.S. Government to advance the manufacture and distribution of this candidate for patients with serious COVID-19 disease,” said Dr. Roger M. Perlmutter, president, Merck Research Laboratories.
Under the agreement, Merck will receive up to approximately $356 million for manufacturing and supply of approximately 60,000-100,000 doses of MK-7110 to the U.S. Government through June 30, 2021 to meet the government’s Operation Warp Speed goals. This approach is intended to expedite delivery of MK-7110 to the American people as quickly as possible, following potential EUA or FDA approval. Merck is also investing to expand its manufacturing capacity to increase supply of MK-7110.
In September 2020, OncoImmune reported topline findings from an interim efficacy analysis of a Phase 3 study evaluating MK-7110 for the treatment of patients with severe and critical COVID-19. An interim analysis of data from 203 participants (75% of the planned enrollment) indicated that hospitalized patients with COVID-19 treated with a single dose of MK-7110 showed a 60% higher probability of improvement in clinical status compared to placebo, as defined by the protocol. The risk of death or respiratory failure was reduced by more than 50%. The study is ongoing.
About SAC-COVID Phase 3 Trial
The SAC-COVID Phase 3 clinical trial (NCT04317040) is a randomized, double blind, placebo-controlled trial designed to evaluate the safety and efficacy of CD24Fc/MK-7110 in hospitalized patients with COVID-19 requiring oxygen support, including those requiring supplemental oxygen, high flow oxygen, and mechanical ventilation. Participants were randomly assigned into two arms receiving either standard of care plus a single dose of MK-7110 via an intravenous infusion on Day 1 or standard of care plus placebo on Day 1. The multi-center trial was initiated in April 2020 and had enrolled 243 patients when the trial was closed due to full enrollment in September 2020.
About Operation Warp Speed
OWS is a partnership among components of the Department of Health and Human Services and the Department of Defense, engaging with private firms and other federal agencies, and coordinating among existing HHS-wide efforts to accelerate the development, manufacturing, and distribution of COVID-19 vaccines, therapeutics, and diagnostics.
About MK-7110 (CD24Fc)
MK-7110 is a potentially first-in-class recombinant fusion protein that targets the innate immune system. In addition to the Phase 3 clinical trial for COVID-19 patients, MK-7110 has been studied for safety in healthy volunteers and in Phase 2 clinical trials for the prevention of graft versus host disease (GVHD) following hematopoietic stem cell transplantation in patients with leukemia. A pivotal Phase 3 clinical trial (NCT04095858) for prophylaxis of GVHD has been initiated nationwide.
About Merck’s Ongoing Commitment to COVID-19
Merck has been committed to developing an effective response to COVID-19 since the early stage of the pandemic and is exploring multiple paths to advance the understanding of SARS-CoV-2 infection. In addition to the development of MK-7110, in collaboration with Ridgeback Biotherapeutics Merck is evaluating molnupiravir, an investigational orally available anti-viral agent being evaluated in two Phase 2/3 trials for the treatment of patients with COVID-19 in both the outpatient and hospital settings. The company is also conducting clinical trials to evaluate two SARS-CoV-2/COVID-19 vaccine candidates: V590, being developed through a collaboration with IAVI, which utilizes a recombinant vesicular stomatitis vector, and V591 which uses a measles virus vector-based platform.
For more than 125 years, Merck, known as MSD outside of the United States and Canada, has been inventing for life, bringing forward medicines and vaccines for many of the world’s most challenging diseases in pursuit of our mission to save 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 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 premier 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 of Merck & Co., Inc., Kenilworth, N.J., USA
This news release of Merck & Co., Inc., Kenilworth, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.
Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of the global outbreak of novel coronavirus disease (COVID-19); the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.
The company undertakes 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 the forward-looking statements can be found in the company’s 2019 Annual Report on Form 10-K and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).
November 25, 2020 Merck (NYSE: MRK) recently announced that it will pay $425 million in cash to acquire privately-held biopharmaceutical company OncoImmune and its potential COVID-19 treatment.
OncoImmune’s CD24Fc is a first-in-class recombinant fusion protein that targets the innate immune system. OncoImmune recently announced positive top-line findings from an interim efficacy analysis of a Phase 3 study evaluating CD24Fc in people with severe cases of the novel coronavirus. Interim analysis of data from 203 participants showed a 60% higher probability of improvement in clinical status, as defined by the protocol, compared to placebo — with a more than 50% reduction in risk of death or respiratory failure.
“Meaningful new therapeutic options are desperately needed for possibly millions of people around the world who will develop severe or critical COVID-19 disease,” said Dr. Roger M. Perlmutter, president Merck Research Laboratories.
“Recent clinical investigations support the view that CD24Fc may provide benefit beyond standard of care therapy for COVID-19 patients requiring oxygen support, and hence will represent an important addition to the Merck pipeline of investigational medicines and vaccines designed to address the COVID-19 pandemic,” Perlmutter said in a news release.
Long-term HIV Infection Can lead to Inflammatory Abnormalities Such as Cardiovascular Disease
On February 1, the Institute of Human Virology (IHV) at the University of Maryland School of Medicine (UMSOM) and OncoImmune, Inc. launched a new Phase II clinical trial called CALIBER, which will test whether OncoImmune’s lead product, CD24Fc, can reduce late effects of HIV infection, such as inflammatory abnormalities including cardiovascular disease. This is intended for use in HIV patients who have been receiving the traditional antiretroviral therapies that control, but do not cure, HIV infection.
The CD24Fc is an experimental drug made of two parts: one is from a cell surface protein called CD24, and the other is from a constant region of an antibody called Fc. CD24 inhibits inflammation triggered by accidental cell death, while Fc helps to make the drug stay in our body for weeks. Earlier studies in experimental animals and heatlhy volunteers have shown the drug reduces inflammation and “bad” cholesterol, called LDL-C, by stimulating a family of immunoregulatory molecules called Siglec.
The new trial will test the drug for its ability to tone down chronic inflammation and metabolic abnormalities in HIV patients. The trial is supported by a grant from the National Heart, Lung and Blood Institute. Pan Zheng, MD, PhD, Professor of Surgery at the Institute Human Virology, University of Maryland School of Medicine and Chief Medical Officer at OncoImmune, and Shyam Kottilil, MBBS, PhD, Professor of Medicine and Director of the Clinical Care and Research Division at the Institute of Human Virology, University of Maryland School of Medicine, are the co-principal investigators of the grant.
HIV affects an estimated 36.7 million people worldwide. In the United States, an estimated 1.1 million people are infected. As access to antiretroviral treatment (ART) has increased, the life expectancy of people infected with HIV has increased. However, among people living with HIV, increased cardiovascular disease and other metabolic disorders contributes to an increased risk of morbidity and mortality.
“Since chronic inflammation is the major underlying cause of the increased risk, a critical challenge is how to control chronic inflammation in HIV patients,” said Dr. Kottilil.
CALIBER is a Phase II, randomized, double-blind, placebo-controlled clinical trial. A cohort of 64 subjects with HIV on antiretroviral therapy will be randomized in a 1:1 fashion to be administered with CD24Fc or placebo during a 4-week window, followed by a 24-week follow-up period to assess safety and efficacy in normalizing lipid profiles, reducing inflammation in the cardiovascular system and liver, as well as reducing immune abnormalities found in HIV patients.
“OncoImmune’s CD24Fc dampens inflammation in HIV patients,” said Dr. Zheng. “Therefore, it holds the promise to reduce many health risks imposed by HIV infection, including heart and liver diseases.”
“This trial is a terrific example of the collaboration between IHV and OncoImmune,” said Robert Gallo, MD, the Homer & Martha Gudelsky Distinguished Professor in Medicine and Co-Founder and Director of the Institute of Human Virology, University of Maryland School of Medicine. “It leverages the intellectual resources as well as the strong clinical infrastructure at IHV, and the expertise of OncoImmune as a leader in fortifying the CD24-Siglec checkpoint of innate immunity. This checkpoint was originally discovered by IHV faculty and OncoImmune co-founders, Drs. Yang Liu and Pan Zheng.”