Kodiak Revives Drug Development Program for Diabetic Retinopathy

Kodiak Sciences is resuming the development program for its eye drug tarcocimab tedromer following the positive Phase III data for the eye drug.

The late-stage clinical trial, named GLOW, examined a 24-week dosing regimen of tarcocimab compared to a sham treatment in patients with moderately severe or severe non-proliferative diabetic retinopathy (NPDR).

Kodiak reported that the trial successfully achieved its primary endpoint, which measured the proportion of patients showing at least a two-step improvement on the Diabetic Retinopathy Severity Scale (DRSS) score, indicating the extent of retinopathy.

The study results demonstrated a remarkable "29-fold" increase in the response rate ratio, with 41.1% of patients receiving the drug achieving a two-step improvement, as opposed to only 1.4% in the sham group. This remarkable difference awarded tarcocimab an extremely low p-value of p = >0.0001.

Additionally, the trial successfully met its secondary endpoints, showcasing a notable reduction in the proportion of patients at risk of sight-threatening complications and an impressive 95% risk reduction in the development of Diabetic Macular Edema (DME).

“This is the first time that six-month dosing in all patients succeeded in treating diabetic retinopathy, which we believe is a meaningful and clinically relevant achievement,” J. Pablo Velazquez-Martin, senior vice president of clinical sciences at Kodiak, said in a statement. “We think that the consistency of the data across all endpoints, where tarcocimab significantly improved the diabetic eye disease status and, importantly, significantly prevented sight-threatening complications, is remarkable.”

The journey of the tarcocimab tedromer project has been marked by challenges this year. In July, Kodiak revealed that the drug failed to deliver significant vision improvement for patients with DME, leading to the discontinuation of the program. At that point, the company was conducting three Phase III trials for the drug. While one of these trials displayed positive results, the other two, known as GLIMMER and GLEAM, did not.

Both GLIMMER and GLEAM trials observed an unexpected increase in the incidence of cataracts among patients over time, along with less-than-ideal efficacy data, as reported by BioSpace at the time. Kodiak CEO Victor Perlroth also expressed deep disappointment with the outcomes of the GLEAM and GLIMMER trials in July.

Nonetheless, Kodiak announced on Monday its intention to conduct an additional study using a commercial formulation of the drug, following discussions with U.S. regulators. However, a specific commencement date for this study has not been determined yet.

“We now have three successful Phase 3 pivotal studies with tarcocimab tedromer across three different retinal vascular and exudative diseases: wet AMD, RVO and NPDR. In recent discussions with the FDA, which included the GLOW data, we believe we have a clear regulatory pathway requiring one additional positive study to support a single BLA submission for all three indications,” Perlroth said in Monday’s announcement.