Rahway To Run A Phase 2b/3 Clinical Trial, On MK-8748 / Tiespectus — For Wet Macular Degeneration…

This continues to mark progress, on one of the more important of Merck’s other recent candidate acquisitions, toward ultimate FDA approval.

We will watch the outcomes closely, as diabetic / wet macular degeneration is a very high-burden condition in the US and Europe.

Here’s the latest, out of Rahway:

…Merck today announced the initiation of a pivotal Phase 2b/3 trial evaluating MK-8748 (also known as Tiespectus), 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)….

Now you know — onward, on a rather chilly gray day, here.

^{[And that seems apropos, as I lost my fifth-youngest brother on this day, exactly six years ago, to COVID-19 — right at the start of that awful US epidemic.]}

नमस्ते