Eye Disease-Focused Kodiak Reboots Once Shelved Tarcocimab Development Program

Kodiak Sciences Inc KOD said its Phase 3 GLOW superiority study evaluating tarcocimab tedromer 5 mg in moderately severe to severe NPDR met its one-year primary endpoint.

Kodiak paused further development of tarcocimab after its GLEAM and GLIMMER studies in diabetic macular edema did not meet their primary endpoint.

The company believes that the one-year head-to-head BEACON results and primary endpoint and key secondary endpoint GLOW results support the development of three clinical prospects: enhanced tarcocimab antibody biopolymer conjugate platform (ABC Platform), enhanced bispecific KSI-501 ABC, and KSI-501 bispecific free protein (not conjugated).

Kodiak has on hand sufficient capital to further develop in parallel all three of these prospects.

At one year, GLOW met its primary endpoint of the proportion of patients with at least a 2-step improvement on the Diabetic Retinopathy Severity Scale (DRSS) score, a grading system measuring the degree of retinopathy. 

Tarcocimab achieved a 29-fold increased response rate ratio, with 41.1% of evaluable patients on tarcocimab demonstrating at least 2-step improvement versus 1.4% of evaluable patients in the sham group. 

Visual acuity and retinal anatomy were improved and stable with tarcocimab on its extended-dosing intervals.

GLOW also met all key secondary endpoints, including greater reductions in the proportion of patients developing sight-threatening complications (such as diabetic macular edema and proliferative diabetic retinopathy) versus sham, demonstrating an 89% decreased risk, achieving 21.0% versus 2.3%. 

Tarcocimab also showed a 95% risk reduction in the development of DME versus sham, from 13.7% on sham versus 0.7% on tarcocimab.

The rates of serious ocular adverse events and intraocular inflammation were similar between the tarcocimab and the sham cohorts, the company noted.

Price Action: KOD shares are down 14% at $2.03 on the last check Monday.