Novel anti-VEGF yields ‘strong’ efficacy results in phase 1b trial
SAN FRANCISCO — The phase 1b study of KSI-301, a novel anti-VEGF antibody polymer, improved best corrected visual acuity, and showed robust efficacy and safety for patients with either wet age-related macular degeneration, diabetic macular edema/diabetic retinopathy or retinal vein occlusion, according to a speaker here.
“KSI-301, an anti-VEGF ABC, has already achieved important milestones, including excellent safety, no cases of intraocular inflammation across 300 plus doses, and strong efficacy across the three major phenotypically variable retinal diseases,” Charles C. Wykoff, MD, PhD, said at Retina Subspecialty Day at the American Academy of Ophthalmology annual meeting.
The phase 1b, open-label study included 105 treatment-naive patients with wet age-related macular degeneration, diabetic macular edema/diabetic retinopathy or retinal vein occlusion randomized 1:3 to receive KSI-301 2.5 mg or 5 mg (Kodiak Sciences). Patients received three initial injections of KSI-301 4 weeks apart and were evaluated for the need for additional KSI-301 doses at 4-week intervals beginning at week 16.
Twenty-five wet AMD patients who reached week 16 before data cutoff demonstrated a best corrected visual acuity (BCVA) letter gain of 5.4 letters and a 72 µm central subfield thickness (CST) improvement from baseline.
Twelve DME patients who reached week 16 before data cutoff experienced an 8.4 BCVA letter gain and a 140 µm CST improvement from baseline.
Fifteen RVO patients who reached week 16 before data cutoff experienced a 21.3 BCVA letter gain and a 353 µm CST improvement from baseline.
“The majority of treated eyes will also be extended to 4 months or beyond without retreatment after three loading doses,” he said.
The phase 1b study has been extended to 18 months to collect additional durability outcomes. – by Robert Linnehan
Reference: Wykoff CC. Extended durability in exudative retinal diseases using the novel intravitreal anti-VEGF antibody polymer conjugate KSI-301: Results from the phase 1b study in patients with wAMD, DME, and RVO. Presented at: American Academy of Ophthalmology annual meeting; October 11-15, 2019; San Francisco.
Disclosure: Wykoff reports he is a consultant for Kodiak Sciences.