Kodiak Breathes New Life into Failed Eye Drug with Phase III Victory

Pictured: Person undergoing an eye exam/iStock, Jacob Wackerhausen

Pictured: Person undergoing an eye exam/iStock, Jacob Wackerhausen

Kodiak Sciences is reviving its development program for eye drug tarcocimab tedromer after getting some positive Phase III data for the candidate, the company announced on Monday.

The late-stage study, known as GLOW, looked at a 24-week dosing regimen of tarcocimab against sham in patients with either moderately severe or severe non-proliferative diabetic retinopathy (NPDR). Kodiak said that the study had met its primary endpoint of the proportion of patients with at least a two-step improvement on the Diabetic Retinopathy Severity Scale, or DRSS score, which measures the degree of retinopathy.

The results had a “29-fold” increased response rate ratio, with 41.1% of patients on the drug having a two-step improvement while there was only a 1.4% in the sham group, earning tarcocimab a p-value of p = >0.0001.

The trial also hit secondary endpoints, including a more significant reduction in the proportion of patients developing sight-threatening complications and a 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 tarcocimab tedromer project has had a rocky road so far this year. In July, Kodiak announced that the drug had not sufficiently improved the vision of patients with DME and would be scrapping the program. At the time, the company had three Phase III trials for the drug. While one trial did show some positive results, the other two—known as GLIMMER and GLEAM—did not.

The two trials noted an unexpected increase in the number of cataracts in patients over time, as well as less than stellar efficacy data, BioSpace reported at the time. Kodiak CEO Victor Perlroth also noted in July that the company was “deeply disappointed with the GLEAM and GLIMMER outcome.”  

A month later, Kodiak’s CMO Jason Ehrlich stepped down.

However, Kodiak said on Monday that it will plan one additional study with a commercial formulation of the drug after speaking with U.S. regulators, but a date has yet to be set for when that study will begin.

“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 Monday’s announcement. 

Nonetheless, the news did not have a positive effect on investors, as Kodiak’s stock price dropped over 6% in Monday morning trading. 

Tyler Patchen is a staff writer at BioSpace. You can reach him at tyler.patchen@biospace.com. Follow him on LinkedIn.

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