Latest news with #Enlicitide
Yahoo
a day ago
- Business
- Yahoo
Merck's Cholesterol Lowering Drug Hits Primary Goal In Two Pivotal Trials
Merck & Co., Inc. (NYSE:MRK) on Monday shared topline results from the first two of three Phase 3 clinical trials evaluating the safety and efficacy of enlicitide decanoate, an investigational, oral proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor for hyperlipidemia on lipid-lowering therapies, including at least a statin. Hyperlipidemia refers to having high levels of lipids (fats) in the blood, including cholesterol and triglycerides. It's a condition that can increase the risk of heart disease and other health problems. The CORALreef HeFH and CORALreef AddOn trials met their primary and all key secondary endpoints, demonstrating statistically significant and clinically meaningful greater reductions in low-density lipoprotein cholesterol (LDL-C) for: Enlicitide compared to placebo (CORALreef HeFH) and other oral non-statin therapies (CORALreef AddOn). There were no clinically meaningful differences in incidences of adverse events (AE) and serious adverse events (SAE) in either from the three Phase 3 trials in the CORALreef clinical development program will be presented at a future scientific congress. Key takeaways from CORALreef HeFH and CORALreef AddOn studies: CORALreef HeFH: Statistically significant and clinically meaningful reductions in LDL-C for enlicitide versus placebo in adults with heterozygous familial hypercholesterolemia (HeFH) who have a history of or are at risk for atherosclerotic cardiovascular disease (ASCVD) and are treated with a statin. CORALreef AddOn: Statistically significant and clinically meaningful reductions in LDL-C for enlicitide versus ezetimibe, versus bempedoic acid and versus ezetimibe and bempedoic acid in adults with hyperlipidemia who have a history of or are at risk for ASCVD and are treated with a statin. The efficacy and safety of enlicitide are being evaluated through the comprehensive CORALreef Phase 3 clinical development program, which aims to enroll approximately 17,000 patients across several trials, including two large ongoing trials, CORALreef Lipids and CORALreef Outcomes. Price Action: MRK stock is trading higher by 0.19% to $79.12 at last check Monday. Read Next:Photo by tada images via Shutterstock Up Next: Transform your trading with Benzinga Edge's one-of-a-kind market trade ideas and tools. Click now to access unique insights that can set you ahead in today's competitive market. Get the latest stock analysis from Benzinga? MERCK & CO (MRK): Free Stock Analysis Report This article Merck's Cholesterol Lowering Drug Hits Primary Goal In Two Pivotal Trials originally appeared on © 2025 Benzinga does not provide investment advice. All rights reserved.
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Business Standard
a day ago
- Business
- Business Standard
Merck's potential cholesterol pill succeeds in late-stage studies
Merck's oral cholesterol pill succeeded in two late-stage studies, marking a win for the drugmaker as it focuses on the development of growth drivers beyond its cancer drugs and vaccines. The company is searching for its next blockbuster candidate as its major revenue driver, Keytruda, is expected to lose patent protection by the end of the decade. Merck's non-statin cholesterol drug, enlicitide decanoate, is being tested for the treatment of hyperlipidemia, a condition that causes elevated buildup of fat in the blood vessels and can lead to heart attacks and strokes. Enlicitide works by blocking PCSK9, a protein that plays a crucial role in regulating cholesterol levels, while statins block an enzyme the liver uses to make cholesterol. BMO Capital Markets analyst Evan Seigerman said Merck's drug could potentially provide a "multi-billion dollar opportunity" that expands the PCSK9 market beyond current injectable therapies. The drug showed meaningful reductions in LDL-C cholesterol, commonly referred to as "bad cholesterol", when compared to placebo and other oral non-statin therapies, Merck said. However, Leerink analysts have noted that Astrazeneca's AZD0780 is a "credible threat" as it has shown a 50.7% reduction in LDL-C levels during a trial. Merck has not given the details on LDL-C reduction for enlicitide. The drug was tested in patients who have a history of, or are at risk for a type of heart disease, and were treated with a statin. Shares of Merck were up 2% in premarket trading.
Yahoo
a day ago
- Business
- Yahoo
Merck claims study success with PCSK9 cholesterol pill
This story was originally published on BioPharma Dive. To receive daily news and insights, subscribe to our free daily BioPharma Dive newsletter. An experimental cholesterol-lowering pill from Merck & Co. succeeded in a pair of late-stage studies, the company said Monday. In one study, Merck's drug, enlicitide, was tested against a placebo in people already taking statins and who have either an inherited condition that causes high cholesterol or are at risk of atherosclerosis. The second trial evaluated enlicitide against other oral therapies, such as ezetimibe, in people on statins and with abnormally high levels of fats in the blood. Merck didn't provide specifics, but said in both cases enlicitide met all of its study objectives and demonstrated 'statistically significant and clinically meaningful reductions' in LDL-C, or 'bad' cholesterol, without any important differences in the number of adverse events. Details will be presented at a future medical meeting. Company shares climbed 2% in early trading Monday. A decade ago, the Food and Drug Administration approved a pair of injectable treatments that could dramatically lower cholesterol in people with heart disease. The drugs, known as PCSK9 inhibitors for the cholesterol-regulating protein they target, were hailed as medical breakthroughs and billed as multibillion-dollar sellers. Instead, their developers struggled to convince payers and physicians of their worth. Sales totals, until recently, have largely disappointed. Merck believes it will have better luck with enlicitide, which could be the first oral medication that blocks PCSK9. The company has bet heavily on its future, enrolling about 17,000 participants across several late-stage studies. And it's counting on enlicitide to become one of the products that can help it grow sales once the patents protecting Keytruda, its dominant cancer immunotherapy, expire later this decade. Questions about its post-Keytruda future have spurred a 40% share slide over the last year and heightened pressure on its next prospects to succeed. The company, for its part, has spoken boldly about enlicitide's promise. Research chief Dean Li has described it as likely becoming the first of its kind available, the 'most effective' cholesterol-lowering pill medicine on the market, and the foundation for future drug combinations. Enlicitide should also be able to sidestep the reimbursement issues long weighing down sales of PCSK9 blockers, CEO Robert Davis said during a presentation in January. Though the drug is a so-called macrocyclic peptide and thus more complicated to make than traditional small molecule pills, Merck has invested significantly in production and believes it can manufacture enlicitide at a low cost. That could help the company 'price it in a way that won't create the excess challenges' others have had and obtain a 'competitive advantage,' Davis said. Still, there is a large collection of branded and generic cholesterol drugs available, as well as multiple newer medicines in advanced testing. AstraZeneca, for one, has a PCSK9 pill in development that some analysts believe to be a meaningful threat to Merck's program. While there are 'early signs' Merck's drug might be more effective, AstraZeneca's could be 'more tolerable and easier to administer,' Leerink Partners analyst Daina Graybosch wrote in April. The size of enlicitide's effects in Phase 3 testing, then, will be closely scrutinized. In Phase 2 trials, a variety of enlicitide doses lowered LDL levels by up to 60% after eight weeks of treatment. One of the Phase 3 studies Merck reported on Monday tested cholesterol levels after 24 weeks, and there is typically a 'degradation in efficacy' when companies move a drug into larger, longer trials, wrote Jefferies analyst Dennis Ding. Ding also speculated that drug adherence could be lower in Merck's studies, as food intake disrupts enlicitide effectiveness. 'The magnitude of benefit will be key to watch,' he wrote.
Yahoo
2 days ago
- Business
- Yahoo
Merck's potential blockbuster cholesterol pill succeeds in late-stage studies
(Reuters) -Merck's oral cholesterol pill succeeded in two late-stage studies, marking a win for the drugmaker as it focuses on the development of growth drivers beyond its cancer drugs and vaccines. The company is searching for its next blockbuster candidate as its major revenue driver, Keytruda, is expected to lose patent protection by the end of the decade. Merck's non-statin cholesterol drug, enlicitide decanoate, is being tested for the treatment of hyperlipidemia, a condition that causes elevated buildup of fat in the blood vessels and can lead to heart attacks and strokes. Enlicitide works by blocking PCSK9, a protein that plays a crucial role in regulating cholesterol levels, while statins block an enzyme the liver uses to make cholesterol. BMO Capital Markets analyst Evan Seigerman said Merck's drug could potentially provide a "multi-billion dollar opportunity" that expands the PCSK9 market beyond current injectable therapies. The drug showed meaningful reductions in LDL-C cholesterol, commonly referred to as "bad cholesterol", when compared to placebo and other oral non-statin therapies, Merck said. However, Leerink analysts have noted that Astrazeneca's AZD0780 is a "credible threat" as it has shown a 50.7% reduction in LDL-C levels during a trial. Merck has not given the details on LDL-C reduction for enlicitide. The drug was tested in patients who have a history of, or are at risk for a type of heart disease, and were treated with a statin. Shares of Merck were up 2% in premarket trading. Verve Therapeutics is also developing a gene therapy to reduce high cholesterol levels, which is expected to be used in combination with other drugs.
Yahoo
2 days ago
- Business
- Yahoo
Merck Announces Positive Topline Results From the First Two Phase 3 CORALreef Trials Evaluating Enlicitide Decanoate for the Treatment of Adults With Hyperlipidemia
Enlicitide demonstrated statistically significant and clinically meaningful reductions in LDL-C in both Phase 3 CORALreef HeFH and CORALreef AddOn trials Enlicitide, a novel macrocyclic peptide, has the potential to be the first approved oral PCSK9 inhibitor RAHWAY, N.J., June 09, 2025--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced positive topline results from the first two of three Phase 3 clinical trials evaluating the safety and efficacy of enlicitide decanoate, an investigational, oral proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor being evaluated for the treatment of adults with hyperlipidemia on lipid-lowering therapies, including at least a statin. The CORALreef HeFH and CORALreef AddOn trials successfully met their primary and all key secondary endpoints, demonstrating statistically significant and clinically meaningful greater reductions in low-density lipoprotein cholesterol (LDL-C) for enlicitide compared to placebo (CORALreef HeFH) and compared to other oral non-statin therapies (CORALreef AddOn). There were no clinically meaningful differences in incidences of adverse events (AE) and serious adverse events (SAE) in either trial. Results from the three Phase 3 trials in the CORALreef clinical development program will be presented at a future scientific congress. Key takeaways from CORALreef HeFH and CORALreef AddOn studies: CORALreef HeFH: statistically significant and clinically meaningful reductions in LDL-C for enlicitide versus placebo in adults with heterozygous familial hypercholesterolemia (HeFH) who have a history of or are at risk for atherosclerotic cardiovascular disease (ASCVD) and are treated with a statin. CORALreef AddOn: statistically significant and clinically meaningful reductions in LDL-C for enlicitide versus ezetimibe, versus bempedoic acid and versus ezetimibe and bempedoic acid in adults with hyperlipidemia who have a history of or are at risk for ASCVD and are treated with a statin. "We are thrilled to bring forward the first Phase 3 results from our clinical development program evaluating enlicitide, which, if approved, would be the first marketed oral PCSK9 inhibitor in the U.S.," said Dr. Dean Y. Li, president, Merck Research Laboratories. "Enlicitide is a novel macrocyclic peptide that has the potential to deliver antibody-like efficacy and specificity for the validated PCSK9 mechanism in the form of a daily oral pill. We are working with urgency to make this oral therapy available to patients worldwide." "Atherosclerotic cardiovascular disease accounts for 85 percent of cardiovascular deaths. Despite available treatment options, cardiovascular-related deaths remain the leading cause of death worldwide and continue to rise," said Dr. Christie M. Ballantyne, principal investigator of the CORALreef HeFH study and Professor of Medicine at Baylor College of Medicine. "LDL-C is a major modifiable risk driver for atherosclerosis and prioritization of LDL-C management should be a cornerstone of cardiovascular risk prevention. Early intervention and intensification of lipid treatment would allow more patients to achieve LDL-C goals." The efficacy and safety of enlicitide are being evaluated through the comprehensive CORALreef Phase 3 clinical development program, which aims to enroll approximately 17,000 patients across several trials, including two large ongoing trials, CORALreef Lipids and CORALreef Outcomes. About CORALreef HeFHCORALreef HeFH (NCT05952869) is a Phase 3, randomized, double-blind, placebo-controlled, multicenter study designed to evaluate the safety and efficacy of enlicitide compared to placebo in adults with HeFH who have a history of or were at risk for a major ASCVD event and are treated with a moderate or high intensity statin with or without other lipid-lowering therapies. The primary endpoints were mean percent change from baseline in LDL-C at week 24, number of participants with one or more adverse events (AEs), and number of participants who discontinued study drug due to an AE. Secondary endpoints included mean percent change from baseline in LDL-C at week 52, mean percent change from baseline in non-HDL-C, ApoB and percent change in Lp(a) at week 24. About CORALreef AddOnCORALreef AddOn (NCT06450366) is a Phase 3, randomized, double-blind, multicenter study designed to evaluate the efficacy and safety of enlicitide compared to ezetimibe, to bempedoic acid, and to ezetimibe and bempedoic acid, in patients with hypercholesterolemia who had a history of a major ASCVD event or were at risk for a major ASCVD event and are treated with a statin. The primary endpoint was the mean percent change from baseline in LDL-C at week 8. Secondary endpoints included mean percent change from baseline in non-HDL-C and ApoB. About enlicitide and PCSK9Enlicitide is an investigational, potentially first oral PCSK9 inhibitor designed to lower LDL-C via the same biological mechanism as currently approved monoclonal antibody injectable PCSK9 inhibitors but in a daily pill form. Enlicitide is a novel oral macrocyclic peptide that binds to PCSK9 and inhibits the interaction of PCSK9 with LDL receptors. PCSK9 plays a key role in cholesterol homeostasis by regulating levels of the LDL receptor, which is responsible for the uptake of cholesterol into cells. Inhibition of PCSK9 with enlicitide prevents the interaction of PCSK9 with LDL receptors. This results in greater numbers of LDL receptors available on the cell surface to remove LDL cholesterol from the blood. About hyperlipidemiaHyperlipidemia is a disorder characterized by an excess of lipids or fats in the blood, affecting approximately 86 million adults (aged 20 and older) in the U.S. Despite adjusting diet or other lifestyle factors, some individuals may not reach recommended lipid levels and will require medication to treat and manage hyperlipidemia. Hyperlipidemia is a major risk driver for the development of ASCVD events, such as heart attacks and strokes, which account for 85 percent of cardiovascular deaths. Merck's focus on cardiovascular diseaseMerck has a long history of developing treatments for cardiovascular disease. More than 60 years ago, we introduced our first cardiovascular therapy—and our scientific efforts to understand and treat cardiovascular-related disorders have continued. Cardiovascular disease continues to be one of the most serious health challenges of the 21st century, and is the leading cause of death worldwide. Approximately 18 million people across the globe die from cardiovascular disease every year; in the United States, one person dies every 36 seconds from cardiovascular disease. Advancements in the treatment of cardiovascular disease can make a critical difference for patients and health systems around the world. At Merck, we strive for scientific excellence and innovation in all stages of research, from discovery through approval and life cycle management. We work with experts throughout the cardiovascular and pulmonary community to advance research that can help improve the lives of patients globally. Information for other currently enrolling cardiovascular studies can be found by visiting: About MerckAt Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world—and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable, and healthy future for all people and communities. For more information, visit and connect with us on X (formerly Twitter), Facebook, Instagram, YouTube and LinkedIn. Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USAThis news release of Merck & Co., Inc., Rahway, 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 candidates that the candidates 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 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 Annual Report on Form 10-K for the year ended December 31, 2024 and the company's other filings with the Securities and Exchange Commission (SEC) available at the SEC's Internet site ( View source version on Contacts Media:Julie Cunningham(617) 519-6264Marc Boston(215) 429-7034Investor:Peter Dannenbaum(732) 594-1579 Steven Graziano(732) 594-1583 Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
