Kodiak Sciences Treats First Patients in Three Phase 3 Studies of KSI-301

Kodiak Sciences announced the first patients have been treated in the randomized, double-masked GLEAM, GLIMMER and BEACON studies, three pivotal Phase 3 studies of KSI-301, Kodiak's anti-VEGF antibody biopolymer conjugate, in treatment-naïve patients with diabetic macular edema (GLEAM and GLIMMER) and macular edema due to retinal vein occlusion (BEACON).

Recruitment of patients from the United States in Kodiak's ongoing global DAZZLE Phase 2b/3 study of KSI-301 in treatment-naïve wet (neovascular) age-related macular degeneration is now complete. Recruitment in Europe is ongoing, and Kodiak expects to complete DAZZLE enrollment this year.

Additional Phase 1b study data continue to show strong durability of KSI-301 compared to the current standard of care. In treatment-naïve patients, after only three loading doses, 72% of wAMD and 79% of DME patients have now achieved a six-month or longer treatment free interval at least once during follow-up. In RVO, 81% of patients have achieved a four-month or longer treatment free interval at least once during follow-up.

"Kodiak continues to make strong operational progress toward our 2022 Vision of submitting a single BLA for KSI-301 in wet AMD, DME and RVO, the main diseases treated today using intravitreal anti-VEGF therapy," said Victor Perlroth, M.D., Chief Executive Officer of Kodiak Sciences. "The randomization of treatment-naïve patients into these three pivotal studies in the third quarter is a critical step to build the clinical evidence for KSI-301 as a safe, effective and highly durable therapy for patients with retinal diseases. I am proud of our team's efforts to plan and initiate these pivotal studies while also continuing our efforts on the DAZZLE pivotal study, which completed enrolling patients in the U.S. in the third quarter as well. These are noteworthy accomplishments at any time, but in light of COVID-19 they are particularly impressive and reflect strong enthusiasm by the retina community for KSI-301 and its profile. With the mature data from our Phase 1b study and the enhancements we have designed into each of these four concurrent pivotal studies as detailed in our July webinar, we are investing with conviction in KSI-301 and our accelerating clinical, manufacturing and pre-commercial activities."

"While anti-VEGF therapies have been approved for the treatment of DME for nearly a decade, diabetes continues to be the leading cause of vision loss in working-age adults in the developed world," said Jason Ehrlich, M.D., Ph.D., Kodiak's Chief Medical and Development Officer. "Because of the high-frequency treatment required with current anti-VEGF medicines, real-world outcomes show that many patients are chronically undertreated and do not achieve optimal vision outcomes as a result. There is a tremendous unmet need for more durable, highly efficacious treatments for DME patients. Building on the strong safety, efficacy and durability data from our ongoing Phase 1b study, our GLEAM and GLIMMER Phase 3 studies are evaluating the efficacy of KSI-301 given as infrequently as every six-months (after three monthly loading doses) compared to aflibercept on its approved every two-month interval (after five monthly loading doses). If these studies are successful, we believe that KSI-301 can become the preferred, first-line treatment option for patients and retina specialists alike."

The Phase 3 GLEAM and GLIMMER studies are global, multi-center, randomized studies designed to evaluate the efficacy, durability and safety of KSI-301 in patients with treatment-naïve diabetic macular edema (DME). In each study, patients are randomized to receive either intravitreal KSI-301 on an individualized dosing regimen every eight to 24 weeks after only three loading doses or intravitreal aflibercept every eight weeks after five loading doses per its label. Each study is expected to enroll approximately 450 patients worldwide. The primary endpoint for both studies is the change from baseline in best-corrected vision at one year, and patients will be treated and followed for two years. Additional information about the GLEAM and GLIMMER studies (also called Studies KS301P104 and KS301P105, respectively) will be available soon at www.clinicaltrials.gov.

The Phase 3 BEACON study is a global, multi-center, randomized study designed to evaluate the efficacy, durability and safety of KSI-301 in patients with treatment-naïve macular edema due to retinal vein occlusion (RVO), including both branch and central subtypes. Patients are randomized to receive either intravitreal KSI-301 every eight weeks after only two loading doses or monthly intravitreal aflibercept per its label, for the first six months. In the second six months, patients in both groups will receive treatment on an individualized basis per protocol-specified criteria. The study is expected to enroll approximately 550 patients worldwide. The primary endpoint is the change from baseline in best-corrected vision at six months, and patients will be treated and followed for one year. Additional information about the BEACON study (also called Study KS301P103) will be available soon at www.clinicaltrials.gov.

The Phase 2b/3 DAZZLE study is a global, multi-center, randomized study designed to evaluate the efficacy, durability and safety of KSI-301 in patients with treatment-naïve wet AMD. Patients are randomized to receive either KSI-301 on an individualized dosing regimen as infrequently as every five months and no more often than every three months or to receive aflibercept on its labeled every eight-week dosing regimen, each after three monthly initiating doses. The study is expected to enroll 550 patients worldwide. The primary endpoint is at one year and each patient will be treated and followed for two years.

KSI-301 is an investigational anti-VEGF therapy built on the Kodiak's Antibody Biopolymer Conjugate (ABC) Platform and is designed to maintain potent and effective drug levels in ocular tissues for longer than existing agents. Kodiak's objective with KSI-301 is to develop a new first-line agent to improve outcomes for patients with retinal vascular diseases and to enable earlier treatment and prevention of vision loss for patients with diabetic eye disease. The Company's Phase 2b/3 DAZZLE pivotal study in patients with treatment-naïve wet AMD was initiated in October 2019, and Kodiak initiated the Phase 3 GLEAM, GLIMMER, and BEACON pivotal studies of KSI-301 in diabetic macular edema and retinal vein occlusion in September 2020. These studies are anticipated to form the basis of the Company's initial BLA to support potential approval and commercialization. An additional pivotal study in patients with non-proliferative diabetic retinopathy is planned. Kodiak Sciences Inc. is developing KSI-301 and owns global rights to KSI-301.