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Published On: Sun, Jul 28th, 2019

Kodiak Sciences reports positive KSI-301 phase 1b results

KSI-301 phase 1b results : Kodiak Sciences, a California-based retinal medicines development company, said that a phase 1b clinical trial evaluating its investigational intravitreal anti-VEGF antibody biopolymer conjugate KSI-301 has yielded positive interim results.

KSI-301 is being studied in patients with anti-VEGF treatment-naïve neovascular (wet) age-related macular degeneration (AMD), diabetic macular (DME), and macular edema caused by retinal vein occlusion (RVO).

Kodiak Sciences said that for all three diseases under the early stage-trial, strong improvements in vision and retinal anatomy were seen over 12 weeks of treatment.

Vision is measured as a change in best-corrected visual acuity (BCVA) on a standardized eye chart. On the other hand, retinal anatomy is measured as a change in retinal central subfield thickness (CST) using optical coherence tomography (OCT) imaging.

Kodiak Sciences reports positive KSI-301 phase 1b results
Kodiak Sciences reports positive KSI-301 phase 1b results. Image courtesy of dream designs at FreeDigitalPhotos.net.

The efficacy data of KSI-301 presented at the American Society of Retina Specialists (ASRS) 2019 Annual Meeting contains outcomes from 35 patients in the trial who had reached the week 12 visit. In the phase 1b clinical trial, patients are being treated with three monthly doses of 2.5 mg or 5 mg KSI-301 and followed for seven months thereafter, with additional treatments as per protocol-specified retreatment criteria.

Jason Ehrlich – Chief Medical Officer and Chief Development Officer of Kodiak Sciences said: “We are pleased with KSI-301’s promising efficacy and safety data to date. In addition to vision and anatomic improvements, we have observed encouraging signs of disease modification.

“In the individual case studies presented at ASRS, 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 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.”

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