Kodiak Sciences announces interim data from ongoing Phase 1B study of KSI-301
Kodiak Sciences announced positive interim results from the ongoing Phase 1b study of KSI-301, its investigational intravitreal anti-VEGF antibody biopolymer conjugate in patients with anti-VEGF treatment-naive neovascular age-related macular degeneration, diabetic macular edema, and macular edema due to retinal vein occlusion. Across all three diseases under study, strong improvements in vision and retinal anatomy were observed over 12 weeks. The efficacy data presented at ASRS include outcomes from 35 patients in the study who had reached the week 12 visit. In the study, patients are being treated with three monthly doses of either 2.5 mg or 5 mg KSI-301 and followed for 7 months thereafter, with additional treatments according to protocol-specified retreatment criteria. A total of 200 injections with KSI-301 have been given to date across the Phase 1a and Phase 1b program with no intraocular inflammation or ocular serious adverse events reported. As of the July 24, 2019 ASRS presentation's data cut-off date, a total of 77 patients were enrolled in the Phase 1b study. Multiple-dose exposure to KSI-301 has been well tolerated. A total of 77 patients have received one injection, 60 patients have received two injections and 44 patients have received three injections. No drug-related adverse events or serious adverse events have been reported. Most of the adverse events reported have been assessed as mild and are consistent with the profile of intravitreally-injected anti-VEGF agents. Eight non-ocular serious adverse events have been reported in four patients, none being assessed as drug-related. The Phase 1b study of KSI-301 is nearing completion of enrollment of the planned cohorts. Based on the positive data observed to date, Kodiak is planning for supplemental cohorts to explore additional scientific questions relevant to KSI-301 and its use for the treatment of retinal diseases. Recruitment in a Phase 2 head-to-head trial of KSI-301 versus aflibercept in treatment-naive wet AMD patients is expected to begin in the third quarter of 2019. In this study, called DAZZLE, approximately 364 patients are planned to be enrolled worldwide. Patients will be randomized to receive either KSI-301 on a dosing regimen as infrequently as every 20 weeks or standard-care aflibercept on its every 8-week dosing regimen. All patients randomized to KSI-301 will be on an every 12-week or longer regimen after three monthly loading doses.