Allegro’s Phase IIb stage 2 trial for DME drug meets primary endpoint
Biotechnology firm Allegro Ophthalmics has reported positive top-line results from the DEL MAR Phase IIb stage 2 clinical trial of luminate as a sequential therapy to treat diabetic macular edema (DME) patients.
Luminate is an integrin peptide therapy being developed to target integrin receptors and inhibit blood vessel construction.
The trial has met the primary endpoint with non-inferior visual acuity gains by using 1mg of luminate equivalent to 1.25mg bevacizumab monotherapy at all time periods.
Luminate additionally demonstrated 12-week durability following completion of three loading doses.
During the double masked, placebo-controlled, randomised, multi-centre trial, 0.5mg and 1.0mg of luminate was evaluated as a sequential therapy and as a combination therapy with anti-VEGF in 80 subjects over five months at 14 US sites.
Allegro Ophthalmics president and chief medical officer Vicken Karageozian said: “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.
“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.”
The results during the trial are reported to have been achieved after one treatment with 1.25mg of bevacizumab, followed by three 1mg luminate injections with 12 weeks of treatment.
The findings were compared to those obtained after administration of five injections every four weeks with bevacizumab.
Furthermore, the vaccine was found to be well-tolerated without drug toxicity or intraocular inflammation, and its safety profile was consistent with previous trial findings.