Kodiak Trial Success
Kodiak Sciences Reports Successful Phase 3 Results For Experimental Wet AMD Therapies
Anonymous
Kodiak Sciences reported that its Phase 3 DAYBREAK trial found both experimental therapies, Zenkuda and tabirafusp-ted (KSI-501), non-inferior to Regeneron’s Eylea in vision gains for people with wet age-related macular degeneration after one year, with favorable safety for both candidates. After the initial loading period, 54% of Zenkuda patients were able to go six months between treatments. Kodiak plans to seek regulatory approval for Zenkuda in the fourth quarter, after the trial results and other late-stage eye-disease study data. Kodiak shares surged after the announcement.
Key Points
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DAYBREAK evaluated both experimental drugs in a single study using a common control arm, allowing Kodiak to compare each candidate against the same Eylea reference group.
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Kodiak said Zenkuda matched or exceeded Eylea’s vision improvement during the initial loading phase; in the trial, Eylea patients were then dosed every eight weeks.
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The 54% of Zenkuda patients who reached six-month durability did so under strict treat-to-dryness retreatment criteria, according to Kodiak.
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Kodiak said its planned Zenkuda filing would also draw on results from four other late-stage studies: one in wet AMD, two in diabetic retinopathy and one in macular edema following retinal vein occlusion.
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