KSI-301 for wet AMD fails to meet primary endpoint in phase 2b/3 trial
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In a phase 2b/3 clinical trial, KSI-301 failed to meet the primary endpoint of noninferior visual acuity gains compared with aflibercept in subjects with wet age-related macular degeneration, according to a Kodiak Sciences press release.
The randomized, double-masked, active comparator-controlled trial enrolled 559 treatment-naive participants in two treatment arms, receiving either KSI-301 5 mg on a flexible long-interval regimen or aflibercept 2 mg on a fixed short-interval regimen. All participants received loading doses at 0, 4 and 8 weeks; those in the aflibercept group received treatment at fixed 2-month intervals, while those in the KSI-301 group received treatment every 3, 4 or 5 months, based on predefined disease activity. All KSI-301 participants were pooled for analysis.
KSI-301 failed to meet the primary endpoint in a phase 2b/3 trial investigating its efficacy, safety and durability.
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The primary endpoint was the average change in best corrected visual acuity at 1 year. KSI-301 given on an extended regimen did not show noninferiority to aflibercept given every 8 weeks. No new safety signals were identified for KSI-301.
“Allowing treatment with KSI-301 no more often than every 12 weeks after the loading phase for every patient turned out to be insufficient,” Victor Perlroth, MD, CEO for Kodiak Sciences, said in the release. “Nonetheless, we believe the results demonstrate a clear anti-VEGF effect, strong durability and a reassuring safety profile.”
KSI-301 is being investigated for the treatment of wet AMD, diabetic macular edema, retinal vein occlusion and nonproliferative diabetic retinopathy.
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