Privately-held biotech Allegro Ophthalmics said today that its Del Mar Phase IIb stage 2 trial met its primary endpoint. The study assessed Luminate as a sequential therapy or combo therapy in 80 patients with diabetic macular edema.
The San Juan Capistrano, Calif.-based company’s Luminate integrin peptide therapy treats neovascular retinal diseases by targeting integrin receptors, which are involved in cell signaling, regulation and in building new blood vessels.
The primary endpoint of the Del Mar Phase II stage 2 trial was non-inferiority to bevacizumab, an anti-VEGF agent, in mean change of best-corrected visual acuity at 20 weeks.
The mean gain in BCVA was 7.1 letters for patients with the group treated with Luminate as a sequential therapy, compared to 6.7 letters for patients in the bevacizumab control group.
“Positive results in Del Mar Stages 1 and 2 continue to confirm Luminate’s safety and efficacy, and its 12-week durability in patients with DME,” president & CMO Dr. Vicken Karageozian said in prepared remarks. “What’s more, about 60% of those treated in the Del Mar trial had been chronic anti-VEGF users, which suggests that Luminate, with its unique mechanism of action, may successfully treat more patients, including those who don’t respond to anti-VEGF.”
“These study results are very promising,” Dr. David Boyer, who serves on Allegro’s scientific advisory board, added. “Not only could Luminate be used as an effective monotherapy with fewer injections, but the latest data suggests that this drug, with its unique mechanism of action, when used as a sequential therapy with an anti-VEGF agent, may provide physicians and DME patients with a new treatment paradigm for DME. Used this way, Luminate with an anti-VEGF pre-treatment could be used to clear VEGF, decrease VEGF production, and cut inflammation at the same time. This should be particularly useful for half of the current patient population that doesn’t respond adequately to repeated anti-VEGF treatments alone.”
The study also showed that Luminate was well-tolerated and Allegro reported that there was no evidence of intraocular inflammation among study participants.