Kodiak Sciences has reported positive interim findings from an ongoing Phase Ib clinical trial of its anti-VEGF antibody biopolymer conjugate, KSI-301, for the treatment of three eye disorders.
KSI-301 is an investigational product intended to provide first-line therapy for retinal vascular diseases. It has been formulated for intravitreal administration.
In the Phase Ib study, the company enrolled patients with wet age-related macular degeneration (AMD), diabetic macular oedema (DME), and macular oedema caused by retinal vein occlusion (RVO).
Participants received three monthly doses of 2.5mg or 5mg KSI-301 and were monitored for the following seven months. They also had additional treatments based on protocol-specified criteria.
Data from 35 patients showed improvements in vision and retinal anatomy over 12 weeks.
Kodiak said that vision was measured as the change in best-corrected visual acuity (BCVA) on a standardised eye chart, with retinal anatomy measurement being the change in retinal central subfield thickness (CST).
As of the data cut-off date, the Phase Ib trial recruited 77 patients who were exposed to multiple doses of KSI-301. The therapeutic was well-tolerated, without any drug-related adverse events or serious adverse events.
According to the results, most of the adverse events observed during the study were mild and consistent with those associated with intravitreally-injected anti-VEGF agents.
Based on these positive findings, the company is planning to expand the study with additional cohorts.
Kodiak Sciences chief medical officer and chief development officer Jason Ehrlich said: “In addition to vision and anatomic improvements, we have observed encouraging signs of disease modification. These findings increase our conviction in the promise of KSI-301 and the further potential of our ABC Platform.”
The company intends to start patient enrolment in a head-to-head Phase II trial of KSI-301 for treatment-naïve wet AMD patients in the third quarter of this year.