KSI-101 - (PINNACLE)

Aug. 6, 2026: Kodiak Sciences (NASDAQ: KOD) said it completed enrollment of the first 300-patient cohort in the Phase 3 PEAK trial of KSI-101 for macular edema secondary to inflammation (MESI), supporting Pivotal Analysis 1. The company reaffirmed that topline data from the 24-week primary endpoint remain on track for December 2026.

KSI-101 is a bispecific protein targeting IL-6 and VEGF. PEAK and PINNACLE are superiority studies comparing KSI-101 5 mg and 10 mg versus sham in MESI, with primary and key secondary endpoints assessed at Week 24. PEAK enrolls patients with more severe disease; PINNACLE enrolls milder disease and some patients with good vision.

Kodiak said completion of enrollment in the second pivotal cohort, covering 600 subjects across PEAK and PINNACLE for Pivotal Analysis 2, is expected in 4Q 2026, with topline data anticipated in 2Q 2027.

The release also cited prior Phase 1b APEX data for KSI-101, including >50% of patients achieving at least 15-letter BCVA gains, >90% resolution of intraretinal and subretinal fluid by Week 8, and favorable tolerability.

Separately, Kodiak said topline data from the Phase 3 DAYBREAK wet AMD study of Zenkuda and KSI-501 are expected in September 2026.