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Kodiak Sciences Announces Encouraging Data from Ongoing Phase 1b Study of KSI-301 in Patients with Wet AMD, DME and RVO at Angiogenesis, Exudation, and Degeneration 2020 Meeting

Encouraging safety profile continues with zero cases of intraocular inflammation after 420 doses in 130 patients Strong anti-VEGF efficacy with extended dosing intervals continues to be observed across all three of the major retinal vascular diseases

Benzinga · 02/08/2020 21:19

Encouraging safety profile continues with zero cases of intraocular inflammation after 420 doses in 130 patients

Strong anti-VEGF efficacy with extended dosing intervals continues to be observed across all three of the major retinal vascular diseases

Promising clinical durability continues to be observed with 84% of wet AMD treated eyes and 76% of DME treated eyes extended to four months or longer before first retreatment

55% of wet AMD eyes extended to six months and 64% of DME eyes extended to six months or longer

Kodiak Sciences Inc. (Nasdaq: KOD) today announced promising safety, efficacy and durability data from the ongoing Phase 1b study of its investigational therapy KSI-301, an intravitreal anti-VEGF antibody biopolymer conjugate, 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 Diana V. Do, M.D., Professor of Ophthalmology at Byers Eye Institute, Stanford University School of Medicine as an oral presentation at the Angiogenesis, Exudation, and Degeneration 2020 meeting in Miami, FL. The study findings presented by Dr. Do can be found on the Kodiak Investor Relations website at http://ir.kodiak.com.

"With further maturation of the Phase 1b study, the safety and efficacy of KSI-301 continue to be very encouraging, and we continue to see the potential for KSI-301 to have class-leading durability across all of the common retinal vascular diseases," said Jason Ehrlich, M.D., Ph.D., Chief Medical Officer of Kodiak Sciences. "Our belief is that a next-generation biologic should bring nearly all wet AMD and DME patients to a three month or longer dose interval and the majority of RVO patients to a two month or longer interval. In the data presented today at Angiogenesis, we observed that 84% of wet AMD eyes and 76% of DME eyes were extended to four months or longer after the last loading doses before receiving their first retreatment. Remarkably, 55% of wet AMD eyes and 64% of DME eyes were extended to six months. In RVO, a disease which typically requires monthly anti-VEGF therapy to achieve the best results, we continued to observe that over half the patients were extended beyond three months after only three loading doses and without receiving retreatment."

"Compared to the data previously presented, more patients have been followed for longer intervals. The safety, efficacy, and durability data continue to be robust and are suggesting the potential for KSI-301 to demonstrate a novel Generation 2.0 durability profile," said Victor Perlroth, M.D., Chief Executive Officer of Kodiak Sciences. "We are very pleased with what we continue to learn about the clinical performance of KSI-301 in this exploratory study, and we are using the data to thoughtfully design high conviction pivotal studies of KSI-301 in each of the core indications. Our DAZZLE study in wet AMD, where KSI-301 is given on an every three-, four-, or five-month dosing interval, continues to recruit well. We appreciate the strong support from the ophthalmology community of patients and providers, and we look forward to initiating pivotal studies in DME, RVO, and NPDR later this year as part of our accelerating development program for KSI-301."