Merck's MK-0616, an Investigational Oral PCSK9 Inhibitor, Significantly Reduced LDL-C in Patients with Hypercholesterolemia in Phase 2b Study

MK-0616 was generally well tolerated and reduced LDL-C across all dose levels compared to placebo

Merck plans to start Phase 3 pivotal study in the second half of 2023

Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced results from the Phase 2b clinical trial evaluating MK-0616, an investigational, once-daily oral proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor in adults with hypercholesterolemia. The primary objective of the study was to evaluate the percent change in low density lipoprotein cholesterol (LDL-C) from baseline to week 8 for 4 doses of MK-0616 (6, 12, 18 and 30 mg) versus placebo. At week 8, all doses of MK-0616 significantly reduced LDL-C compared to placebo and the placebo-adjusted reduction from baseline ranged from 41.2% (6 mg, CI 95%, -47.8 to -34.7; p nd Annual Scientific Session together with World Congress of Cardiology (ACC.23/WCC) and simultaneously published in the Journal of The American College of Cardiology.

Inhibition of PCSK9 increases the removal of LDL-C from the bloodstream. MK-0616 is a macrocyclic peptide and is designed to lower LDL-C via the same biological mechanism as currently approved injectable PCSK9 inhibitors, but in a daily pill form. High LDL-C, if left untreated, can lead to a high risk of atherosclerotic cardiovascular disease (ASCVD) events, such as heart attacks and strokes.

"Despite widely available statin treatments, millions of patients are still not able to lower their cholesterol to the guideline-recommended levels and as a result are at increased risk for serious cardiovascular complications associated with atherosclerosis," said Dr. Christie M. Ballantyne, principal investigator of the study and Professor of Medicine at Baylor College of Medicine. "Currently available PCSK9 inhibitors are effective tools to treat hypercholesterolemia but must be administered by injection. With these promising data showing that MK-0616 reduced LDL-C levels by up to 60.9%, MK-0616 should be further studied for its potential as a daily oral medicine."

"These data reinforce our confidence that MK-0616 could become the first oral PCSK9 inhibitor, with the potential to change the way patients with hypercholesterolemia who need additional LDL-C reduction are treated. This may allow many more patients to reach their LDL-C treatment goals," said Dr. Joerg Koglin, vice president, global clinical development, Merck Research Laboratories. "We look forward to advancing this program into Phase 3 development in the second half of this year."

Additional data from the Phase 2b Study for MK-0616 (MK-0616-008)
MK-0616-008 ( NCT05261126 ) was a randomized, double-blind, placebo-controlled, multi-center Phase 2b trial designed to evaluate the efficacy and safety of MK-0616 administered daily compared to placebo in adult participants with hypercholesterolemia and a broad spectrum of ASCVD risk. Participants were receiving a range of lipid-lowering therapies from no statin to high-intensity statin. The primary efficacy endpoint was the percent change in LDL-C from baseline to week 8. Supportive secondary endpoints (not multiplicity controlled) were percent change in apolipoprotein B-100 (ApoB) and in non-high-density lipoprotein-C (non-HDL-C) from baseline to week 8, and the proportion of participants who achieved protocol-defined LDL-C goals at week 8.

In total, 381 participants from age 18-80 with hypercholesterolemia with a moderate to high risk of atherosclerotic cardiovascular disease were randomized 1:1:1:1:1 to receive MK-0616 at a dose of 6 mg (n=77), 12 mg (n=76), 18 mg (n=76), or 30 mg (n=76) or placebo (n=76) once daily. The study population consisted of 49% female, 66% White, 17% Asian and 6% Black/African American, and 40% Latino or Hispanic.

At week 8, all doses of MK-0616 significantly reduced LDL-C compared to placebo and the results were generally consistent across the prespecified subgroups. The LDL-C placebo-adjusted reduction from baseline were as follows for each of the four doses studied (p

MK-0616 was generally well-tolerated with no overall trends across treatment groups in discontinuation rates or adverse events at week 16. No serious adverse events that were considered by the investigator to be related to treatment with MK-0616 were reported.

About PCSK9 and MK-0616
PCSK9 plays a key role in cholesterol homeostasis by regulating levels of LDL receptors, which are responsible for the uptake of cholesterol into cells. Inhibition of PCSK9 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.

Discovered and developed by Merck, MK-0616 is an investigational, potentially first oral PCSK9 inhibitor designed to lower low density lipoprotein (LDL) cholesterol. MK-0616 is a macrocyclic peptide that binds to PCSK9 and inhibits the interaction of PCSK9 with LDL receptors.

About Hypercholesterolemia
Hypercholesterolemia, a disorder in which there are elevated LDL-C levels in the blood, affects approximately 73 million adults in the U.S. It is a major risk factor associated with ASCVD, which is the leading cause of death in the U.S. and globally. Despite adjusting diet and taking statin therapies, many patients with hypercholesterolemia are still not reaching their LDL-C lowering goals as recommended by guidelines.

Merck's Focus on Cardiovascular and Pulmonary Disease
Merck 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. Approximately 18 million people across the globe die every year, and 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 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: https://www.merckclinicaltrials.com/cardiovascular .

About Merck
At 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 www.merck.com and connect with us on Twitter , Facebook , Instagram , YouTube and LinkedIn .

Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA
This 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 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 Annual Report on Form 10-K for the year ended December 31, 2022 and the company's other filings with the Securities and Exchange Commission (SEC) available at the SEC's Internet site ( www.sec.gov ).

Media Contacts:

Julie Cunningham
(617) 519-6264

Kristina Rey
(917) 880-0025

Investor Contacts:

Peter Dannenbaum
(908) 740-1037

Damini Chokshi
(908) 740-1807

News Provided by Business Wire via QuoteMedia

MRK
The Conversation (0)
Merck Announces First-Quarter 2023 Financial Results

Merck Announces First-Quarter 2023 Financial Results

  • First Quarter 2023 Reflected Continued Strong Underlying Performance Across Key Growth Drivers, Particularly in Oncology and Vaccines
  • Total Worldwide Sales Were $14.5 Billion, a Decrease of 9% From First Quarter 2022; Excluding LAGEVRIO, Growth Was 11%; Excluding LAGEVRIO and the Impact of Foreign Exchange, Growth Was 15%
    • KEYTRUDA Sales Grew 20% to $5.8 Billion; Excluding the Impact of Foreign Exchange, Sales Grew 24%
    • GARDASIL/GARDASIL 9 Sales Grew 35% to $2.0 Billion; Excluding the Impact of Foreign Exchange, Sales Grew 43%
    • LAGEVRIO Sales Declined 88% to $392 Million; Excluding the Impact of Foreign Exchange, Sales Declined 87%
  • GAAP EPS Was $1.11; Non-GAAP EPS Was $1.40; GAAP and Non-GAAP EPS Include $0.52 of Charges Related to Acquisition of Imago and Collaboration and Licensing Agreement With Kelun-Biotech
  • Announced Proposed Acquisition of Prometheus Biosciences to Strengthen Immunology Pipeline
  • Presented Compelling Data From Innovative Cardiovascular Pipeline With:
    • Positive Phase 3 Results for Sotatercept
    • Positive Phase 2b Results for MK-0616; Plans to Start Phase 3 Studies in 2023
  • Advanced Oncology Research Efforts, Sharing Notable Progress for Earlier Stages of Disease in Certain Tumor Types, Including:
    • Positive Topline Results From Phase 3 KEYNOTE-671 Trial
    • Positive Detailed Results in Collaboration With Moderna From Phase 2b KEYNOTE-942/mRNA-4157-P201 Trial
  • 2023 Financial Outlook
    • Raises and Narrows Expected Full-Year 2023 Worldwide Sales Range To Be Between $57.7 Billion and $58.9 Billion, Including Negative Impact of Foreign Exchange of Approximately 2 Percentage Points; Outlook Includes Approximately $1.0 Billion of LAGEVRIO Sales
    • Lowers and Narrows Expected Full-Year 2023 GAAP EPS Range To Be Between $5.85 and $5.97, Reflecting Zetia Antitrust Litigation Settlement
    • Raises and Narrows Expected Full-Year 2023 Non-GAAP EPS Range To Be Between $6.88 and $7.00, Including Negative Impact of Foreign Exchange of Approximately 4 Percentage Points
    • Outlook Does Not Reflect Any Impact From Proposed Acquisition of Prometheus Biosciences, Which Is Expected to Close in Third Quarter 2023, and Would Result in a One-Time Charge to Both GAAP and Non-GAAP Results of Approximately $10.3 Billion or Approximately $4.00 per Share

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced financial results for the first quarter of 2023.

�Inspired by our commitment to bring bold science forward to address critical unmet patient needs, we began 2023 with significant advancements across our innovative pipeline," said Robert M. Davis, chairman and chief executive officer, Merck. "Our first-quarter results are a reflection of the focused execution of our science-led strategy, strong performance across our key growth drivers, continued momentum commercially and operationally, and most importantly the collective and dedicated efforts of our colleagues around the world. I'm proud of the progress we've made, and we will continue to move with speed and agility to deliver value for patients and shareholders, now and well into the future."

News Provided by Business Wire via QuoteMedia

Keep reading...Show less
BRODSKY & SMITH SHAREHOLDER UPDATE: Notifying Investors of the Following Investigations: Spectrum Pharmaceuticals, Inc. , BELLUS Health Inc , Prometheus Biosciences, Inc. , Univar Solutions Inc.

BRODSKY & SMITH SHAREHOLDER UPDATE: Notifying Investors of the Following Investigations: Spectrum Pharmaceuticals, Inc. , BELLUS Health Inc , Prometheus Biosciences, Inc. , Univar Solutions Inc.

Brodsky & Smith reminds investors of the following investigations. If you own shares and wish to discuss the investigation, contact Jason Brodsky ( jbrodsky@brodskysmith.com ) or Marc Ackerman ( mackerman@brodskysmith.com ) at 855-576-4847. There is no cost or financial obligation to you.

Spectrum Pharmaceuticals, Inc. (Nasdaq – SPPI)

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less
OTC:BCTXF

BriaCell Announces Grant to Investigator Dr. Saveri Bhattacharya at Sidney Kimmel Cancer Center – Jefferson Health

Highlights:

  • Grant awarded to Dr. Saveri Bhattacharya, Principal Investigator of the Phase I/IIa combination study of Bria-IMT™ with KEYTRUDA® (by Merck) in advanced breast cancer at Thomas Jefferson University.
  • Merck to provide KEYTRUDA® for use in the combination study.
  • The Investigator Grant validates and will build on the encouraging preliminary data from BriaCell’s combination study of Bria-IMT™ with KEYTRUDA® (Link).

BriaCell Therapeutics Corp. (“BriaCell” or the “Company”) (TSXV:BCT, OTCQB:BCTXD), a clinical-stage biotechnology company specializing in targeted immunotherapy for advanced breast cancer, today announced that Dr. Saveri Bhattacharya, a board-certified medical oncologist and recognized expert in breast cancer treatment at the Sidney Kimmel Cancer Center – Jefferson Health in Philadelphia, PA, has been selected to receive support from the Merck Investigator Studies Program (“MISP”). The Investigator Grant is a highly coveted award granted by Merck & Co., Inc. (“Merck”) (NYSE: MRK) to leading investigators with highly innovative clinical studies.

Keep reading...Show less

Merck Announces Q4 and Full-Year 2019 Financial Results

Merck (NYSE:MRK) reported quarterly worldwide sales at US$11.9 billion in Q4 in its financial results for the fourth quarter of 2019 and its full fiscal 2019 year.

As quoted in the press release:

Keep reading...Show less
OTC:BCTXF

BriaCell’s Clinical Data Accepted to be Presented at the Annual Symposium of Society of Surgical Oncology 2020 in Boston

Safety and early efficacy data to be presented from clinical trial of Bria-IMT™ in combination with immune checkpoint inhibitors in advanced breast cancer:

  • Bria-IMT™ in combination with pembrolizumab (KEYTRUDA®; by Merck & Co., Inc.);
  • Bria-IMT™ in combination with INCMGA00012 (by Incyte Corporation).

BriaCell Therapeutics Corp. (“BriaCell” or the “Company”) (TSXV:BCT, OTCQB:BCTXD), a clinical-stage biotechnology company specializing in targeted immunotherapies for advanced breast cancer, is pleased to announce that the data of its clinical studies with its lead product candidate, Bria-IMT™, will be presented the at the Annual Symposium of Society of Surgical Oncology (SSO) 2020 – International Conference on Surgical Cancer Care taking place March 25-28 in Boston, MA.

Keep reading...Show less

Arvinas and Pfizer's Vepdegestrant Significantly Improves Progression-Free Survival for Patients with ESR1-Mutant, ER+/HER2- Advanced Breast Cancer

  • Pivotal Phase 3 VERITAC-2 clinical trial results presented at ASCO demonstrate 2.9-month improvement in median progression-free survival when compared to fulvestrant in second line-plus patients with an estrogen receptor 1 mutation
  • Vepdegestrant was generally well tolerated, with few discontinuations and low rates of gastrointestinal-related adverse events
  • Vepdegestrant is the first and only   PROteolysis TArgeting Chimera   (PROTAC) evaluated in a Phase 3 clinical trial and the first to show benefit in patients with breast cancer
  • Data to be featured in a late-breaking oral presentation at ASCO and simultaneously published in the New England Journal of Medicine
  • Arvinas will host a conference call to discuss these results on Monday, June 2, at 8:00 a.m. ET

Arvinas, Inc. (Nasdaq: ARVN) and Pfizer Inc. (NYSE: PFE) today announced detailed results from the Phase 3 VERITAC-2 clinical trial (NCT05654623) evaluating vepdegestrant monotherapy versus fulvestrant in adults with estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+HER2-) advanced or metastatic breast cancer (MBC) whose disease progressed following prior treatment with cyclin-dependent kinase (CDK) 46 inhibitors and endocrine therapy. These data, which were highlighted in the American Society of Clinical Oncology (ASCO ® ) press briefing and selected for Best of ASCO, will be presented today in a late-breaking oral presentation (Abstract LBA1000) and have been simultaneously published in the New England Journal of Medicine .

Keep reading...Show less

Pfizer's BRAFTOVI® Combination Regimen Cuts the Risk of Death in Half for Patients with BRAF V600E-Mutant Metastatic Colorectal Cancer

  • Pivotal results from the Phase 3 BREAKWATER trial showed 51% risk reduction in death compared to standard-of-care treatment
  • BRAFTOVI combination regimen also demonstrated 47% risk reduction in disease progression or death compared to standard-of-care treatment, meeting the trial's dual primary endpoint of progression-free survival
  • First and only combination regimen with targeted therapy to improve survival outcomes for treatment-naïve patients with BRAF V600E-mutant metastatic colorectal cancer

Pfizer Inc. (NYSE: PFE) today announced statistically significant and clinically meaningful survival results from the Phase 3 BREAKWATER trial evaluating BRAFTOVI ® (encorafenib) in combination with cetuximab (marketed as ERBITUX ® ) and mFOLFOX6 (fluorouracil, leucovorin, and oxaliplatin) in patients with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation. These data will be presented today in an oral presentation (Abstract LBA3500) at the 2025 American Society of Clinical Oncology (ASCO ® ) Annual Meeting and have been simultaneously published in the New England Journal of Medicine .

News Provided by Business Wire via QuoteMedia

Keep reading...Show less

Hearing Against Pfizer Set For 30 May In Contraceptive 'Depo-Provera' Multidistrict Litigation Overseen By Levin Papantonio

  • Global pharmaceutical company Pfizer Inc. is facing a multidistrict litigation (MDL No.3140) in the USA, currently comprising approximately 400 lawsuits against the company.
  • This MDL follows a study by EPI-PHARE (Roland et al.) published in March 2024 in the British Medical Journal , which found that women who had used the Pfizer contraceptive injection Depo-Provera 1 for more than one year were 5.6 times more likely to develop an intracranial meningioma, a type of brain tumor.
  • An estimated 74 million women globally receive Depo-Provera injections according to a 2019 UN study 2 .

A Case Management Conference (CMC) in the Depo-Provera legal action against Pfizer Inc. (NYSE:PFE) will take place on Friday, 30 May at 9:00am CT in the United States Courthouse is Pensacola, Florida. The litigation is being brought on behalf of women in the USA who developed meningiomas after receiving at least 4 consecutive injections of Pfizer's Depo-Provera (DMPA). One of the law firms appointed to the Plaintiff's Executive Committee responsible for overseeing the MDL is Levin Papantonio, which has helped to secure more than $80 billion in jury verdicts and settlements against some of the world's largest corporations, including Johnson & Johnson, BP, Dupont, 3M, Merck and big tobacco. The law firm is currently acting for plaintiffs in the Talcum Powder Litigation against Johnson & Johnson and the Preterm Infant Nutrition Products Liability Litigation against Abbott Laboratories and Mead Johnson, owned by Reckitt Benckiser.

News Provided by Business Wire via QuoteMedia

Keep reading...Show less

Astellas and Pfizer's XTANDI Shows Long-Term Overall Survival in Metastatic Hormone-Sensitive Prostate Cancer

  • Five-year follow-up data from the Phase 3 ARCHES trial shows XTANDI (enzalutamide) plus androgen deprivation therapy (ADT) reduces risk of death by 30%
  • After a median follow-up of 61.4 months, treatment with XTANDI (enzalutamide) plus ADT was associated with a 66% probability of survival at five years compared to 53% probability of survival with placebo plus ADT
  • XTANDI (enzalutamide) is the first and only androgen receptor inhibitor to demonstrate an overall survival benefit at five years in men with metastatic hormone-sensitive prostate cancer
  • Data continue to show wide-ranging effect of treatment with XTANDI (enzalutamide) plus ADT across various patient subgroups, notably those with high-volume disease, no prior docetaxel use, and synchronous disease
  • Long-term data reinforce XTANDI (enzalutamide) plus ADT as a standard of care

Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura "Astellas") and Pfizer Inc. (NYSE: PFE) today announced longer-term follow-up results from an open-label extension of the Phase 3 ARCHES ( NCT02677896 ) study, reporting a five-year follow up of overall survival (OS) benefits and a 30% reduction in the risk of death in men with metastatic hormone-sensitive prostate cancer (mHSPC) treated with XTANDI ™ (enzalutamide), an androgen receptor pathway inhibitor (ARPI), plus androgen deprivation therapy (ADT) compared to placebo plus ADT. These data will be presented during an oral presentation (Abstract #5005) at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago ( Tuesday, June 3 9:45 a.m.- 12:45 p.m. US CT).

News Provided by PR Newswire via QuoteMedia

Keep reading...Show less

Pfizer Enters into Exclusive Licensing Agreement with 3SBio

Pfizer Inc. (NYSE: PFE) today announced it has entered into an exclusive global, ex-China, licensing agreement with 3SBio, Inc. (01530.HK), a leading Chinese biopharmaceutical company, for the development, manufacturing and commercialization of SSGJ-707, a bispecific antibody targeting PD-1 and VEGF, currently undergoing several clinical trials in China for non-small cell lung cancer, metastatic colorectal cancer, and gynecological tumors. SSGJ-707 has shown initial efficacy and safety data in a promising class of cancer medicines. 3SBio plans to initiate the first Phase 3 study in China in 2025.

Under the terms of the agreement, 3SBio and its subsidiaries Shenyang Sunshine Pharmaceutical Co., Ltd. and 3S Guojian Pharmaceutical (Shanghai) Co., Ltd. will grant Pfizer an exclusive global license to develop, manufacture and commercialize SSGJ-707 worldwide, excluding China. The agreement also provides Pfizer the option of commercialization rights in China. 3SBio will receive an upfront payment of $1.25 billion and is eligible to receive milestone payments associated with certain development, regulatory and commercial milestones up to $4.8 billion as well as tiered double-digit royalties on sales of SSGJ-707, if approved.

News Provided by Business Wire via QuoteMedia

Keep reading...Show less
Various blister packs with pills and capsules in different colors and shapes.

Trump Signs Sweeping Order to Slash Drug Prices, Pressure Pharma Giants

US President Donald Trump has signed a sweeping executive order aimed at dramatically reducing prices for prescription drugs, vowing to end “foreign free-riding” on American pharmaceutical innovation.

The order directs federal agencies to pressure both drug manufacturers and wealthy foreign countries to bring their prices in line with those paid in the US, or face aggressive trade and regulatory actions.

“In case after case, our citizens pay massively higher prices than other nations pay for the same exact pill, from the same factory, effectively subsidizing socialism abroad with skyrocketing prices at home,” Trump states in the order.

Keep reading...Show less

Latest Press Releases

Related News

×