Kodiak Sciences (KOD) said Thursday that topline results from a phase 3 trial of tarcocimab tedromer demonstrated superiority over sham in patients with diabetic retinopathy and met its primary endpoint with high statistical significance.
The company said 62.5% of patients treated with tarcocimab achieved at least a two-step improvement in diabetic retinopathy severity score at week 48, compared with 3.3% in the sham group.
The investigational therapy also met key secondary endpoints, including an 85% reduction in the risk of developing sight-threatening complications compared with sham, and a higher proportion of patients achieving at least a three-step improvement in severity score, Kodiak Sciences said.
The company said the treatment was administered via intravitreal injection with all patients transitioned to a six-month dosing interval following a loading phase.
Kodiak Sciences added that tarcocimab demonstrated favorable safety was well tolerated with a 2.3% cataract adverse event rate.
Based on the results, Kodiak Sciences said tarcocimab now has a multi-indication biologics license application-ready profile and the company plans to accelerate its submission timeline.
Shares of Kodiak Sciences were up over 34% in premarket trading Thursday.
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