Kodiak Sciences announced promising safety, efficacy and durability data from its ongoing phase 1b study of its investigational therapy KSI-301 in patients with treatment-naïve wet age-related macular degeneration (AMD), diabetic macular edema (DME) and retinal vein occlusion (RVO).
The results were presented by Charles C. Wykoff, MD, PhD, a clinical investigator in the study, as an oral presentation at the “First-Time Results of Clinical Trials” session of the American Academy of Ophthalmology Annual Meeting’s Retina Subspecialty Day. Dr. Wykoff is Director of Research at Retina Consultants of Houston. The study findings presented by Dr. Wykoff can be found on the Kodiak Investor Relations website at http://ir.kodiak.com.
“We continue to observe encouraging safety and efficacy data in the Phase 1b study of KSI-301, and the emerging durability data are remarkable,” Jason Ehrlich, MD, PhD, Chief Medical Officer of Kodiak Sciences, said in a company news release. “In wet AMD, a next-generation intravitreal biologic would bring nearly all patients to a three month or longer dose interval. Our early data suggest this is achievable using KSI-301, with 87% of wet AMD patients extending beyond three months after the last loading dose without receiving retreatment. In DME, a pan-retinal disease that typically has a high initial treatment burden, we observed that 82% of patients were extended beyond three months without receiving retreatment following only three initial loading doses. Further, we are seeing promising early signs of improvement in diabetic retinopathy, with 40% of patients improving in diabetic retinopathy severity level within the first twelve weeks of treatment and no patients worsening. In RVO, a disease which typically requires monthly anti-VEGF therapy to achieve the best results, we observed that over half the patients were extended beyond three months after only three loading doses without receiving retreatment and over a quarter of patients received their first retreatment at two months. Interestingly, we also see potential signs of disease modification in RVO as evidenced by a sequentially increased time to retreatment in patients who have received more than one retreatment to date.”
“These new results reinforce our belief in the potential for KSI-301 to reduce treatment burden and improve vision outcomes for patients. To that end, we are designing pivotal studies to demonstrate meaningful differentiation of KSI-301 in each of the retinal vascular diseases,” said Victor Perlroth, MD, Chief Executive Officer of Kodiak Sciences. “We have begun dosing patients in our DAZZLE pivotal study of KSI-301 in wet AMD, where KSI-301 will be given on an every three-, four- or five-month dosing interval. We look forward to discussing our accelerating plans for the clinical development of KSI-301 at our R&D Day on Monday, October 14.”