“We intend to progress our portfolio of three late-stage clinical assets as rapidly as we can into Phase 3 value inflection points,” said Victor Perlroth, CEO of Kodiak Sciences. “We were pleased with the Phase 1 study results of KSI-501, our anti-IL-6 and VEGF trap bispecific antibody biopolymer conjugate, in patients with diabetic macular edema (“DME”). The results of this study demonstrated that repeated monthly dosing of KSI-501 was safe and well tolerated and achieved clinically meaningful and sustained visual acuity gains. KSI-501 contains three tiers of innovation: (1) a two-target mechanism potently inhibiting both the dominant VEGF pathway and the IL-6 inflammation pathway, (2) a design based on Kodiak’s ABC Platform that we believe holds the potential for 6-month durability in the majority of patients, and (3) an enhanced KSI-501 formulation informed from tarcocimab’s commercial manufacturing scale-up. We believe that our supportive Phase 1 data and the multi-tiered design position the molecule to address unmet needs of patients with high prevalence retinal vascular diseases. As a result, we are planning to advance KSI-501 into a Phase 3 pivotal study (DAYBREAK) in patients with wet AMD later this year,” Perlroth added.
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