DAZZLE clinical trial : Kodiak Sciences doses first patients with KSI-301 in phase 3 wet AMD trial

Kodiak Sciences said that it has treated the first patients in the phase 2 DAZZLE clinical trial of KSI-301, its investigational intravitreal anti-VEGF antibody biopolymer conjugate, in wet age-related macular degeneration (wet AMD).

The DAZZLE trial (also called KSI-CL-102) is designed to assess the safety and efficacy of KSI-301 in AMD patients who are treatment-naïve.

The California-based retinal medicines development company has a target to enroll 368 patients in the global, multi-center and randomized mid-stage clinical trial.

Victor Perlroth – CEO of Kodiak Sciences, commenting on the DAZZLE clinical trial, said: “Treating the first patients in this pivotal study is an important step for Kodiak as we grow the company and accelerate our efforts with KSI-301.

“On World Sight Day, we recognize that patients with wet AMD often need frequent eye injections of an anti-VEGF medication to preserve their vision.

“Next generation anti-VEGF biologics are thought to support half the patients on an every two-month interval and half the patients on an every three-month interval. Using our proprietary ABC Platform, we designed KSI-301 from the outset as a therapy with extended durability.”

Kodiak Sciences doses first patients with KSI-301 in DAZZLE clinical trial. Image courtesy of dream designs at FreeDigitalPhotos.net.

The DAZZLE clinical trial will compare the efficacy of KSI-301 on every three-, four-, or five-month dosing against aflibercept on its every two-month interval.  Recently,  Kodiak Sciences released early data from an ongoing phase 1b clinical trial of KSI-301 in which the majority of wet AMD patients treated with the anti-VEGF antibody reached a four- or five-month interval without the need of retreatment.

In the DAZZLE clinical trial, patients are randomly grouped to get KSI-301 on an individualized dosing regimen as infrequently as every five months and no more often than every three months or to get standard of care aflibercept on its every eight-week dosing regimen, each after three monthly initiating doses.

The primary endpoint of the DAZZLE clinical trial is at one year and all the patients will be treated and followed for two years.

KSI-301 has been designed to sustain potent and effective drug levels in ocular tissues for a longer period compared to existing agents. The investigational wet AMD drug was built on Kodiak Sciences’ Antibody Biopolymer Conjugate (ABC Platform).

The retinal medicines development company is looking to develop  KSI-301 as a new first-line agent to enhance outcomes for patients with retinal vascular diseases and to facilitate earlier treatment and prevention of loss of vision in patients having diabetic eye disease.