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

Kodiak Sciences announced that 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 AMD 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 6-month or longer treatment free interval at least once during follow-up. In RVO, 81% of patients have achieved a 4-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,” Victor Perlroth, MD, Chief Executive Officer of Kodiak Sciences, said in a company news release. “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,” Jason Ehrlich, MD, PhD, Kodiak’s Chief Medical and Development Officer, said in the news release. “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 6-months (after three monthly loading doses) compared to aflibercept on its approved every 2-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.”