Kodiak Sciences Receives Positive Phase I Data

Kodiak Sciences Inc. achieved 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-naïve neovascular (wet) age-related macular degeneration (AMD), diabetic macular edema (DME), and macular edema due to retinal vein occlusion (RVO).  
 
Across all three diseases under study, strong improvements in vision and retinal anatomy were observed over 12 weeks. 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. 
 
"We are pleased with KSI-301's promising efficacy and safety data to date," said Jason Ehrlich, M.D., Ph.D., Kodiak's Chief Medical Officer and Chief Development Officer. "In addition to vision and anatomic improvements, we have observed encouraging signs of disease modification. In the individual case studies using OCT angiography, we observed normalization of retinal vascular flow in an RVO patient seen as early as one week after the first dose and reduction in choroidal neovascularization size and vascular flow rate in a wet AMD patient. In a DME patient with proliferative retinopathy, we observed conversion to non-proliferative retinopathy and a two-step improvement in diabetic retinopathy severity score at the 12-week assessment. These findings increase our conviction in the promise of KSI-301 and the further potential of our ABC Platform."
 
Recruitment in a Phase 2 head-to-head trial of KSI-301 versus aflibercept in treatment-naïve wet AMD patients ("DAZZLE" Study) is expected to begin in the third quarter of 2019. 

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