Merck and EyeBio Announce Initiation of Phase 2b/3 Clinical Trial for Restoret™ for the Treatment of Diabetic Macular Edema

Rhea-AI Summary

Merck (NYSE: MRK) and its subsidiary EyeBio have initiated the Phase 2b/3 BRUNELLO trial for Restoret™ (MK-3000) in treating diabetic macular edema (DME). MK-3000 is an investigational, potentially first-in-class tetravalent, tri-specific antibody acting as an agonist of the Wnt signaling pathway. The trial's initiation follows promising results from the Phase 1/2 AMARONE study of MK-3000 in patients with DME and neovascular age-related macular degeneration (NVAMD). Dr. David Guyer, CEO of EyeBio, emphasized the potential of MK-3000 for retinal disease patients and highlighted the significance of the BRUNELLO trial in developing new treatment options for DME.

Positive

• Initiation of Phase 2b/3 BRUNELLO trial for Restoret™ (MK-3000) in treating diabetic macular edema
• Promising results from Phase 1/2 AMARONE study in DME and NVAMD patients
• Potential first-in-class tetravalent, tri-specific antibody with novel mechanism of action

Negative

• None.

Medical Research Analyst

The initiation of the Phase 2b/3 BRUNELLO trial for Restoret™ (MK-3000) is a significant step in developing a potential first-in-class treatment for diabetic macular edema (DME). As a tetravalent, tri-specific antibody acting as an agonist of the Wnt signaling pathway, MK-3000 represents a novel approach in retinal disease treatment. The progression to this advanced trial stage, based on promising Phase 1/2 AMARONE study results, indicates positive early efficacy and safety data. This development could potentially offer a new treatment option for DME patients, addressing an important unmet medical need in ophthalmology. However, it's important to note that success in early-phase trials doesn't guarantee Phase 3 success or FDA approval. Investors should monitor the trial's progress closely, as positive outcomes could significantly impact Merck's ophthalmology portfolio and market position.

Financial Analyst

This clinical trial initiation represents a strategic move for Merck in the lucrative ophthalmology market. The global diabetic macular edema treatment market was valued at $3.7 billion in 2020 and is projected to reach $7.7 billion by 2028, with a CAGR of 9.8%. If successful, Restoret™ could capture a significant share of this growing market. However, investors should consider that drug development is risky and expensive, with only 12% of drugs entering clinical trials ultimately receiving FDA approval. The financial impact on Merck will depend on the trial's success and potential market penetration. While positive results could boost Merck's stock, it's important to note that any revenue impact is likely several years away, given the typical timeline for Phase 3 trials and regulatory approval processes.

Oncology Doctor

While my primary expertise is in oncology, the mechanism of action of Restoret™ (MK-3000) is intriguing from a broader medical perspective. The Wnt signaling pathway, which this drug targets, plays important roles in cell proliferation, migration and differentiation. In oncology, we often seek to inhibit this pathway due to its involvement in cancer progression. However, in retinal diseases like DME, activating Wnt signaling could potentially promote tissue repair and regeneration. This approach highlights the complexity of biological pathways and how their modulation can have different effects in various diseases. The development of a tetravalent, tri-specific antibody also demonstrates the advancing sophistication of biologic therapies. If successful, this approach could inspire similar strategies in other fields, including cancer treatment, potentially leading to more targeted and effective therapies across multiple disease areas.

RAHWAY, N.J.--(BUSINESS WIRE)-- Merck (NYSE: MRK), known as MSD outside of the United States and Canada, and EyeBio, a wholly-owned subsidiary of Merck & Co., Inc., Rahway, N.J., USA, today announced the initiation of the Phase 2b/3 BRUNELLO trial evaluating Restoret™ (MK-3000, formerly EYE103) for the treatment of diabetic macular edema (DME).

MK-3000 is an investigational, potentially first-in-class tetravalent, tri-specific antibody that acts as an agonist of the Wingless-related integration site (Wnt) signaling pathway. The initiation of the BRUNELLO trial is based on results from the open-label, Phase 1/2 AMARONE study of MK-3000 in patients with DME and neovascular age-related macular degeneration (NVAMD).

“Data from the Phase 1/2 AMARONE study provided early evidence for the potential of MK-3000 for patients with retinal disease,” said Dr. David Guyer, founder, chief executive officer and president of EyeBio. “The initiation of the BRUNELLO trial marks an important milestone as we work with our new colleagues at Merck, driven by the common purpose to deliver new, much needed options for patients with diabetic macular edema.”

About the BRUNELLO trial
BRUNELLO is a randomized, double masked Phase 2b/3 trial (NCT06571045) evaluating the efficacy and safety of two dose levels of intravitreal (IVT) Restoret (MK-3000) versus active control ranibizumab in patients with DME. Eligible patients will be randomized 1:1:1 to receive low and high dose regimens of MK-3000 or ranibizumab every four weeks for the first year. In the second year, the frequency of treatment for participants will shift based on a personalized treatment interval (PTI) algorithm. The dual primary endpoints are safety and mean change in best-corrected visual acuity (BCVA) from baseline to week 52 in the study eye of the participants, using standardized Early Treatment of Diabetic Retinopathy Study (ETDRS) vision. For further information about the BRUNELLO trial, please visit www.clinicaltrials.gov.

About diabetic macular edema
Diabetic macular edema (DME) is a serious retinal condition that poses a risk to vision, potentially leading to blindness and a reduced quality of life if left untreated. DME impacts an estimated 750,000 people in the United States and occurs when damaged blood vessels leak into the retina, resulting in swelling in the macula, the central region of the retina crucial for precise vision necessary for everyday activities. The prevalence of DME is anticipated to rise with the increasing incidence of diabetes.

About Restoret
Restoret (MK-3000, formerly EYE103) is an investigational, potentially first-in-class tetravalent, tri-specific Wnt antibody designed to address unmet medical need in patients with retinal diseases, including diabetic macular edema (DME) and neovascular age-related macular degeneration (NVAMD). MK-3000 is administered as an intravitreal injection seeking to eliminate vascular leakage in retinal diseases by agonizing the Wnt pathway with the goal of restoring and maintaining the blood-retinal barrier. Preclinical evidence indicates that agonizing the Wnt pathway in the retina may reduce vascular leakage.

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 X (formerly 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 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, 2023 and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).

View source version on businesswire.com: https://www.businesswire.com/news/home/20240904993839/en/

Media Contacts:

Robert Josephson

(203) 914-2372

Carly Myar

(917) 227-5957

Investor Contacts:

Peter Dannenbaum

(732) 594-1579

Damini Chokshi

(732) 594-1577

Source: Merck & Co., Inc.

FAQ

What is the purpose of Merck's Phase 2b/3 BRUNELLO trial for MRK stock?

The BRUNELLO trial aims to evaluate Restoret™ (MK-3000) for the treatment of diabetic macular edema (DME), potentially leading to a new treatment option for patients with retinal disease.

How does Restoret™ (MK-3000) work in treating diabetic macular edema for MRK?

Restoret™ (MK-3000) is an investigational, tetravalent, tri-specific antibody that acts as an agonist of the Wingless-related integration site (Wnt) signaling pathway, offering a novel approach to treating DME.

What were the results of the Phase 1/2 AMARONE study for Merck's MRK stock?

The Phase 1/2 AMARONE study provided early evidence for the potential of MK-3000 in treating patients with diabetic macular edema (DME) and neovascular age-related macular degeneration (NVAMD), leading to the initiation of the BRUNELLO trial.

Who is leading the development of Restoret™ for Merck's MRK stock?

Restoret™ is being developed by EyeBio, a wholly-owned subsidiary of Merck & Co., Inc., in collaboration with Merck (NYSE: MRK).