$KOD

With the news, it broke above the red diagonal resistance and got stuck at the resistance band
Kodiak climbs on late-stage trial win for diabetic retinopathy therapy
Kodiak Sciences (KOD) added ~33% in the premarket on Thursday after the company announced that a Phase 3 trial for its eye disorder therapy, Zenkuda, reached key goals in patients with diabetic retinopathy, an eye complication of diabetes.
Citing 48-week data, the Palo Alto, California-based biotech said Zenkuda reached its GLOW2 trial’s primary endpoint as nearly 63% of trial subjects experienced a ≥2-step improvement in the diabetic retinopathy severity scale (DRSS) with statistical significance.
In comparison, about 3% of those in the sham arm of the study experienced ≥2-step improvement in DRSS.
The anti-vascular endothelial growth factor (VEGF) therapy also demonstrated statistically significant superiority to sham in terms of several secondary endpoints, including one related to reducing the risk of developing prespecified sight-threatening complications.
Safety data indicate that the Zenkuda intravitreal injection was well tolerated among patients with a low occurrence of common ocular adverse events.
Building on the success of the company’s pivotal GLOW1 study for Zenkuda in DR, Kodiak (KOD) had expanded GLOW2 to include those with proliferative diabetic retinopathy and mild diabetic macular edema in addition to patients with moderately severe to severe DR.
Patients in both studies received either sham injections or Zenkuda 5 mg with an ultimate treatment interval of every six months. Given positive GLOW2 results, Kodiak (KOD) said it has “a multi-indication Biologics License Application (BLA)-ready profile," and it intends to speed up BLA submission plans.