Kodiak Sciences said its phase 3 GLOW2 study of Zenkuda in diabetic retinopathy met its main goal with a sharp step-up in response versus sham.
At week 48, 62.5% of patients treated with Zenkuda achieved at least a 2-step improvement in diabetic retinopathy severity score, compared with 3.3% in the sham group. That is a gap of 59.2 percentage points, or roughly 19 times the response rate.
The drug also cut the risk of sight-threatening complications by 85%: 2.4% of Zenkuda patients developed such complications versus 15.8% of sham-treated patients. That is a difference of 13.4 percentage points. A third key measure also favored Zenkuda, with 13.7% of treated patients posting at least a 3-step improvement versus 0% for sham.
Safety data were also tightly tracked. Kodiak said there were no cases of intraocular inflammation and no retinal vasculitis or occlusive retinal vasculitis. Cataract adverse events in the study eye were reported in 2.3% of Zenkuda patients versus 1.6% of sham patients, a 0.7-point difference.
The study included patients taking GLP-1 medications and those not taking them. Among Zenkuda-treated patients, 60.0% of GLP-1 users achieved at least a 2-step improvement, compared with 64.3% of non-users, a 4.3-point spread.
GLOW2 was designed to confirm GLOW1, where 41.1% of Zenkuda patients reached at least a 2-step improvement versus 1.4% on sham. In that earlier study, 2.3% of Zenkuda patients developed sight-threatening complications, compared with 21.0% of sham patients.
Kodiak said GLOW2 used a loading phase followed by extended dosing, with all patients on a 6-month interval by the end of the study. The company said the results support moving Zenkuda toward a biologics license application and accelerating that filing timeline. Today the company's shares have moved 1.69% to a price of $27.15. Check out the company's full 8-K submission here.
