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Novel integrin peptide therapy yields visual acuity gains on par with Avastin for DME
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BOSTON — Sequential therapy with 1 mg ALG-1001 yielded equivalent visual acuity gains as treatment with bevacizumab monotherapy in patients with diabetic macular edema, according to a study presented here.
“The safety profile was excellent. There was very little in the way of [serious adverse events] at all,” David Boyer, MD, said at the American Society of Retina Specialists meeting, where he delivered topline results for the phase 2 stage 2 DEL MAR study.
The DEL MAR study was undertaken to investigate the safety and efficacy of Luminate (ALG-1001, Allegro), a synthetic oligopeptide that inhibits integrin receptors and arrests aberrant blood vessel growth in neovascular tissue in patients with diabetic retinopathy.
In stage 1 of the study, best corrected visual acuity improvements were equivalent between treatment with ALG-1001 and treatment with Avastin (bevacizumab, Genentech).
In this stage 2 study, safety and efficacy of ALG-1001 with bevacizumab pretreatment or ALG-1001 combined with bevacizumab were compared.
Eighty patients were included in five arms of the study: 0.5 mg or 1 mg of ALG-1001 with one dose of bevacizumab pretreatment; 0.5 mg or 1 mg of ALG-1001 combined with bevacizumab; and bevacizumab monotherapy control.
Primary endpoint was best corrected visual acuity equivalence in both sequential therapy arms at 20 weeks.
“The study met the primary endpoint of best corrected visual acuity in both the sequential therapy arms, so 1 mg and 0.5 mg ALG-1001. The 1 mg ALG-1001 sequential treatment showed gains that were equivalent to bevacizumab given monthly,” Boyer said.
No additional benefit was seen in the combined ALG-1001 and bevacizumab arms. – by Patricia Nale, ELS
Reference:
Boyer D. Topline results from prospective, double-masked phase 2b clinical trial evaluating ALG-1001 (Luminate) compared to bevacizumab in patients with DME. Presented at: American Society of Retina Specialists annual meeting; Aug. 11-15, 2017; Boston.
Disclosure: Boyer reports he is a consultant for Allegro.