Merck & Co. Inc. (NYSE:MRK) on Thursday announced topline results from the pivotal Phase 2b/3 BRUNELLO trial in adults with diabetic macular edema (DME).
DME is a serious eye complication of diabetes where high blood sugar damages tiny retinal blood vessels, causing them to leak fluid into the macula (the central part of the retina responsible for sharp vision) and making it swell.
BRUNELLO is the first of two Phase 2b/3 trials evaluating remigromig (MK-3000, formerly EYE103), an investigational tetravalent, tri-specific antibody designed to activate the Wingless-related integration site (Wnt) pathway, which is involved in the repair and maintenance of the blood-retinal barrier.
52-Week Efficacy And Safety Outcomes
At 52 weeks, both doses of remigromig (0.5 mg and 0.8 mg) independently demonstrated non-inferiority to active control 0.5 mg Roche Holding AG’s (OTC:RHHBY) unit Genentech’s Lucentis (ranibizumab) for mean change from baseline in best-corrected visual acuity (BCVA) in patients with DME.
Higher rates of proliferative diabetic retinopathy (PDR), vitreous hemorrhage, and treatment discontinuations due to adverse events were observed in the remigromig treatment arms compared with ranibizumab.
In addition, both doses of remigromig were generally well tolerated. Further analyses are underway to characterize these findings.
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Expansion Across Merck’s Ophthalmology Pipeline
The BRUNELLO topline results build on Merck’s advancing ophthalmology pipeline, which is aimed at promoting retinal recovery by addressing specific retinal diseases associated with vascular leakage and neovascularization, including DME, neovascular (wet) age-related macular degeneration (NVAMD) and macular edema secondary to retinal vein occlusion (RVO).
In addition to BRUNELLO, remigromig is being evaluated in the ongoing pivotal Phase 2b/3 BAROLO study in patients with DME and in a Phase 2 proof-of-concept study (SUPER TUSCAN) in patients with NVAMD and RVO.
Broader Retinal Pipeline And MK-8748 Development
In addition, the company is developing MK-8748 (also known as Tiespectus, EYE201), an 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.
MK-8748 is currently being studied in two pivotal Phase 2b/3 trials for the treatment of NVAMD, TORRONTES and MALBEC, and in two pivotal Phase 3 studies for the treatment of DME, SANGIOVESE and SYRAH.
MRK Price Action: Merck & Co shares were up 0.28% at $148.49 at the time of publication on Thursday, according to Benzinga Pro data.
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