Why Are Kodiak Sciences Shares Trading Lower Today?

Kodiak Sciences Inc KOD shares are tumbling after the company released topline results from three Phase 3 studies of tarcocimab tedromer, a novel antibody biopolymer conjugate, for neovascular age-related macular degeneration (AMD) and diabetic macular edema.

The DAYLIGHT study evaluated the efficacy and safety of a high-intensity dosing regimen of tarcocimab tedromer in 557 treatment-naïve subjects with wet AMD. 

The DAYLIGHT study met the primary endpoint of non-inferior visual acuity gains for tarcocimab dosed monthly compared to Regeneron Pharmaceutical Inc's REGN Eylea (aflibercept) dosed every eight weeks following three monthly loading doses. 

Tarcocimab was safe and well tolerated in the study and with a low rate of intraocular inflammation.

The GLEAM and GLIMMER studies of tarcocimab tedromer enrolled 460 and 457 treatment-naïve subjects with DME, respectively. 

The company said that although high proportions of patients on meaningfully longer treatment intervals were observed with tarcocimab, with half of patients on every 24-week dosing at the primary endpoint, the GLEAM and GLIMMER studies did not meet their primary efficacy endpoints of showing non-inferior visual acuity gains for tarcocimab dosed every 8 to 24 weeks after three monthly loading doses compared to aflibercept given every eight weeks after five monthly loading doses. 

An unexpected increase in cataracts was observed over time in the tarcocimab arms of both GLEAM and GLIMMER. 

Kodiak's initial evaluation suggests that this contributed meaningfully to the failure of each study. 

In the DAYLIGHT study, no imbalance in cataracts was observed between wet AMD patients receiving tarcocimab or aflibercept throughout the one-year study period despite the intensive monthly tarcocimab dosing regimen.

Kodiak has decided to discontinue further development of tarcocimab.

In August last year, Kodiak Sciences' BEACON Phase 3 study of tarcocimab tedromer met the primary endpoint of non-inferior change from baseline in visual acuity in macular edema due to retinal vein occlusion.

Price Action: KOD shares are down 56.10% at $3.20 during the premarket session on the last check Monday.