Kodiak Sciences’ KSI-301 fails to meet primary endpoint in wet AMD trial

Kodiak Sciences said that its antibody biopolymer conjugate KSI-301 failed to meet the primary endpoint in a phase 2b/3 clinical trial in neovascular (wet) age-related macular degeneration (wet AMD).

The primary endpoint of the trial was achieving non-inferior visual acuity gains with the treatment of KSI-301, which is an anti–vascular endothelial growth factor therapy (anti-VEGF therapy) in comparison to aflibercept administered every eight weeks.

The randomized, double-masked, active comparator-controlled clinical trial assessed the efficacy, durability and safety of the antibody biopolymer conjugate in 559 participants, of whom nearly 80% were enrolled in the US, said the California-based retinal medicines development company.

Kodiak Sciences had split the wet AMD clinical trial into two treatment arms, with one of them receiving KSI-301 5mg on a flexible long-interval regimen and the other subjected to aflibercept 2mg on a fixed short-interval regimen.

As per the results, KSI-301 showed strong durability and was safe and well tolerated, but could not register non-inferior visual acuity gains for patients dosed on extended regimens.

A pre-specified secondary analysis at year 1 assessing durability showed 59% of patients in the KSI-301 arm achieved five-month dosing with visual acuity gains and anatomic improvements comparable to the overall aflibercept group.

Victor Perlroth — Kodiak Sciences CEO said: “Allowing treatment with KSI-301 no more often than every 12 weeks after the loading phase for every patient turned out to be insufficient.

“Nonetheless, we believe the results demonstrate a clear anti-VEGF effect, strong durability and a reassuring safety profile. We think that these data continue to support the potential of our ABC Platform to significantly extend treatment intervals in retinal disorders in a safe and convenient manner.”