Kodiak Sciences Announces Presentation of KSI-301 Phase 1b Clinical Study Data Focused on DME at AAO 2020 Virtual Meeting

Kodiak Sciences announced that a pre-recorded presentation of clinical study data on its investigational therapy KSI-301 is available at the American Academy of Ophthalmology (AAO) 2020 Virtual Annual Meeting.

Details of the presentation are as follows:

Event: Late Breaking Developments, Part II

Title: One Year and Beyond: Long-term Multiple-dose Study of KSI-301, an Anti-VEGF Antibody Biopolymer Conjugate with Extended Durability, in wAMD, DME, and RVO

Presenter: Arshad M Khanani, M.D., M.A., managing partner and director of clinical research, Sierra Eye Associates, clinical associate professor of ophthalmology, University of Nevada

Presentation date and time: The pre-recorded presentation containing slides and audio will be available to AAO 2020 Virtual attendees starting on Wednesday, November 11. The presentation slides are also available on the “Events and Presentations” section of Kodiak’s website at http://ir.kodiak.com/.

“As diabetic eye disease remains the leading cause of new blindness in working-aged Americans, and we recently started enrolling our GLEAM and GLIMMER pivotal studies in patients with diabetic macular edema, Dr. Khanani’s presentation at the AAO late-breaking session focuses on DME. The data suggest a transformative effect that allows for a combination of strong efficacy and remarkable durability. The results are out of the ordinary when benchmarked to current anti-VEGF agents,” Jason Ehrlich, MD, PhD, Chief Medical & Development Officer of Kodiak Sciences, said in a company news release. “We also remain very pleased with the safety profile of KSI-301, and the most recent phase 1b safety data are reflected in Dr. Khanani’s presentation. To date, KSI-301 has been administered more than 1,500 times to more than 400 patients across the entire development program, representing more than 250 patient-years of clinical experience. The presentation also refreshes the durability proportions of phase 1b wet AMD and DME patients who achieved a 6 months or longer treatment-free interval during follow-up and RVO patients who achieved a 4 months or longer treatment-free interval during follow-up.”

“Today’s presentation provides perspectives on KSI-301’s emerging efficacy and durability with an emphasis on helping the audience to understand and link the strong performance of KSI-301 to its precision engineering and underlying scientific rationale,” said Victor Perlroth, MD, Chief Executive Officer. “Today’s presentation also includes new case examples showing long-term disease modification in diabetic macular edema and proliferative diabetic retinopathy patients with no or very few retreatments in treatment naïve patients following only three loading doses. Given the unsustainable treatment burden of current anti-VEGFs, the unmet need for longer-lasting treatment of diabetic eye disease is clear, and confirmation of KSI-301’s durability, efficacy and safety profile in GLEAM and GLIMMER would be an important advance for patients and physicians.”

About the GLEAM and GLIMMER Studies

The phase 3 GLEAM and GLIMMER studies are global, multicenter, 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 study (also called Study KS301P104) and the GLIMMER study (also called Study KS301P105) can be found on www.clinicaltrials.gov under Trial Identifiers NCT04611152 and NCT04603937, respectively (https://clinicaltrials.gov/ct2/show/NCT04611152 and https://clinicaltrials.gov/ct2/show/NCT04603937).

About the BEACON Study

The phase 3 BEACON study is a global, multicenter, 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 8 weeks after only two loading doses or monthly intravitreal aflibercept per its label, for the first 6 months. In the second 6 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 6 months, and patients will be treated and followed for 1 year. Additional information about the BEACON study (also called Study KS301P103) can be found on www.clinicaltrials.gov under Trial Identifier NCT04592419 (https://clinicaltrials.gov/show/NCT04592419).

About the DAZZLE Study

The phase 2b/3 DAZZLE study is a global, multicenter, 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 3 monthly initiating doses. The study is expected to enroll approximately 550 patients worldwide. The primary endpoint is at 1 year and each patient will be treated and followed for two years. Additional information about DAZZLE (also called Study KSI-CL-102) can be found on www.clinicaltrials.gov under Trial Identifier NCT04049266 (https://clinicaltrials.gov/show/NCT04049266).