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Novel bispecific monoclonal antibody explored for treating wet AMD
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SAN FRANCISCO — Single and multiple-dose injections of a bispecific monoclonal antibody were deemed “safe and well tolerated” in patients with difficult to treat neovascular age-related macular degeneration.
Reporting results of a phase 1 study of RG7716 (Roche) at the American Society of Retina Specialists annual meeting, Pravin U. Dugel, MD, described the agent as able to “potently and selectively” neutralize VEGF and angiopoietin-2.
Pravin U. Dugel, MD
“Like any other phase 1 study, there are only two goals. One is to demonstrate safety, and the other is to demonstrate a biological signal,” Dugel said. Regarding safety, there were no observed dose-limiting toxicities or events and no unexpected adverse events.
Patients enrolled in the study had neovascular AMD, best corrected visual acuity of 20/40 to 20/400, and persistent choroidal neovascularization activity despite three or more anti-VEGF treatments in the preceding 6 months, with the last intravitreal treatment received 4 or more weeks before day 1 of study treatment.
“Most importantly, these patients had an average duration of disease of greater than 2 years,” Dugel said. “These patients had severe disease and were difficult to treat.”
Patients were divided into two treatment groups. A single ascending dose group received 0.5 mg, 1.5 mg, 3 mg and 6 mg of drug. The second multiple ascending dose group received three monthly treatments each of 3 mg and 6 mg of drug.
Regarding a biological signal, 28 days after the last dose in the single-dose group, the median improvement in visual acuity was seven letters. In the 6-mg arm of the multiple-dose group, median change was +7.5 letters with a decrease in central subfield thickness of 117 µm. – by Patricia Nale, ELS
Reference:
Dugel P. A novel anti-VEGF/anti-angiopoietin2 bispecific monoclonal antibody for wet age-related macular degeneration and diabetic macular edema. Presented at: American Society of Retina Specialists annual meeting; Aug. 9-14, 2016; San Francisco.
Disclosure: Dugel reports he is a consultant for Roche Pharmaceuticals, a consultant and minor shareholder in Aerpio Therapeutics, a consultant for Alcon, a consultant for Genentech, a consultant for Novartis, and a consultant and minor shareholder in Ophthotech.