Kodiak Sciences Plummets After Disappointing Phase 2b_3 Results

Feb 23, 2022 By MarketDepth

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Kodiak Sciences Inc. (Nasdaq: KOD) announced today that its Phase 2b/3 study of KSI-301 had failed to meet the primary endpoint.

Shares Plummeted

Shares of Kodiak Sciences Inc. (Nasdaq: KOD) plummeted 78% following the announcement. 

80% In USA

Its study of KSI-301, a novel antibody biopolymer conjugate, in treatment-naïve subjects with neovascular age-related macular degeneration included 559 participants, approximately 80% of whom were enrolled in the United States.

Efficacy Missed

Despite KSI-301 demonstrating strong durability as well as safety and tolerability, it did not meet the primary efficacy endpoint of showing non-inferior visual acuity gains for subjects dosed on extended regimens compared to aflibercept given every eight weeks, according to the company’s press release.

“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, Kodiak’s Chief Executive Officer

Dr. Carl Regillo, MD, Chief of the Retina Service at Wills Eye Hospital in Philadelphia and a study investigator, added, “We learned that the study design stretched it too far for the roughly 30% of patients who could have benefited from more VEGF inhibition than the minimal every 3 months in the study.”

Full results from the study are expected to be presented at a future medical symposium.