11.16.20

Kodiak Sciences Completes Enrollment of Phase 2b/3 Pivotal Study of KSI-301 in Patients with Wet AMD

Source: Kodiak Sciences

Kodiak Sciences announced that recruitment has concluded in its DAZZLE pivotal study of KSI-301, Kodiak’s anti-VEGF antibody biopolymer conjugate, in patients with wet age-related macular degeneration (AMD). DAZZLE was planned to enroll 550 treatment-naïve patients worldwide; the target enrollment has been exceeded and recruitment into the study is now closed.

“We are pleased to have exceeded our enrollment target for DAZZLE and to have recruited the study in just over 1 year despite the challenges presented by the COVID-19 pandemic. We are very grateful for the enthusiasm and support of the retina clinical trial community in working together with us to study KSI-301’s potential,” Victor Perlroth, Chief Executive Officer of Kodiak Sciences, said in a company news release. “With DAZZLE having a 1-year primary efficacy endpoint, Kodiak is on track for a topline data readout of the study in early 2022, an important milestone as part of our 2022 Vision.”

“Wet AMD remains a leading cause of vision loss in the elderly and real-world data show that vision outcomes are compromised by the unsustainable and intensive treatment burden of current medicines. In DAZZLE, we are studying a more pragmatic and achievable regimen of KSI-301 given once every 3, 4 or 5 months,” said Jason Ehrlich, MD, PhD, Kodiak’s Chief Medical & Development Officer. “We look forward to the last DAZZLE patient’s 1-year visit in late 2021 and to analyzing and releasing the primary results in early 2022. The Kodiak team is also executing well on the rest of the KSI-301 development program. Our pivotal studies in diabetic macular edema (DME) and retinal vein occlusion are off to a strong start. The recent presentation of KSI-301 data at the American Academy of Ophthalmology Virtual Meeting highlighted the promising combination of efficacy and durability seen with KSI-301 in DME, a leading cause of vision loss in working-aged people.”

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 5 months and no more often than every 3 months or to receive aflibercept on its labeled every 8-week dosing regimen, each after 3 monthly initiating doses. The study has enrolled over 550 patients worldwide. The primary endpoint is at 1 year and each patient will be treated and followed for 2 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).

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 8 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 2 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).

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