RAHWAY, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the initiation of a pivotal Phase 2b/3 trial evaluating MK-8748 (also known as Tiespectus, EYE201), a novel investigational bispecific antibody that directly activates Tie2 signaling and inhibits vascular endothelial growth factor (VEGF), for the treatment of neovascular (wet) age-related macular degeneration (NVAMD).
The study, known as MALBEC, is the first trial of a broader late-phase development program for MK-8748, with a second study in NVAMD scheduled to begin this year (NCT07496567). The decision to advance into pivotal studies is based on results from the Phase 1/2a RIOJA trial (NCT06664502), a two-part study evaluating MK-8748 in patients with either NVAMD, macular edema secondary to branch retinal vein occlusion (BRVO) or diabetic macular edema (DME).
“Despite available therapies, many patients with neovascular age-related macular degeneration remain at risk of further vision loss due to continued vascular leakage,” said Dr. David Guyer, founder, chief executive officer and president, EyeBio, a wholly-owned subsidiary of Merck & Co., Inc., Rahway, N.J., USA. “With its differentiated dual mechanism directly agonizing Tie2 and inhibiting VEGF, MK-8748 has the potential to offer a novel approach to maintain vascular stability for patients with serious retinal diseases.”
Merck is advancing an ophthalmology pipeline aimed at addressing certain retinal diseases associated with vascular leakage and neovascularization, including NVAMD, DME and macular edema secondary to retinal vein occlusion (RVO). In addition to MK-8748, the company is developing MK-3000 (also known as Restoret, EYE103), an investigational, potentially first-in-class tetravalent, tri-specific antibody that activates the Wingless-related integration site (Wnt) signaling pathway that is being studied in two fully enrolled, ongoing registrational Phase 2b/3 studies for the treatment of DME.
About the MALBEC trial
MALBEC is a randomized, double-masked, pivotal Phase 2b/3 trial (NCT07440225) evaluating the safety and efficacy of two dose levels of intravitreal (IVT) MK-8748 versus active control aflibercept 2mg. Eligible patients will be randomized 1:1:1 to receive two dose regimens of MK-8748 or aflibercept 2mg; participants will initially receive three monthly (Q4W) IVT administrations of MK-8748 or aflibercept, followed by treatments every 8 weeks (Q8W) until week 48. After week 48, participants will be treated at intervals determined based on individualized response to treatment, with the last study visit at week 96. The primary endpoint is mean change in best-corrected visual acuity (BCVA) from baseline to Year 1 in the study eye of the participants, using standardized Early Treatment of Diabetic Retinopathy Study (ETDRS) vision. For further information about the MALBEC trial, please visit www.clinicaltrials.gov.
About neovascular age-related macular degeneration
Neovascular (wet) age-related macular degeneration (NVAMD) is the most common cause of vision loss among older adults, caused by the growth of abnormal blood vessels under the retina. In the United States, it is estimated that nearly 1.5 million people are living with late-stage AMD, including NVAMD.
About MK-8748
MK-8748 (also known as Tiespectus, EYE201) is a novel investigational bispecific antibody with a dual mechanism that directly activates the Tie2 pathway and inhibits VEGF with the goal of stabilizing retinal and choroidal blood vessels and reducing fluid accumulation in the macula. Preclinical and early clinical evidence indicate that dual pathway modulation may help improve vascular stability in the retina and support vision preservation in patients with certain vascular retinal diseases. MK-8748 is currently being studied in a pivotal Phase 2b/3 trial for the treatment of NVAMD, with a second study scheduled to begin this year.
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
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Contacts
Media:
Carly Myar
carly.myar@merck.com
John Cummins
john.cummins2@merck.com
Investor:
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(732) 594-1579
Hayley Kasko
(732) 594-4237
