Kodiak CMO steps down after Phase III flops for eye therapy

layoffs, resignation

Kodiak CMO steps down after Phase III flops for eye therapy

Published: Aug 18, 2023

By Tristan Manalac

BioSpace

Kodiak Sciences’ Chief Medical Officer and Chief Development Officer Jason Ehrlich is stepping down from both of his positions, effective Aug. 25, the company announced in an SEC filing posted Thursday.

According to Kodiak, Ehrlich informed them of his decision on Wednesday and that his resignation “was not the result of a disagreement with the company on any matter relating to the company’s operations, policies or practices.”

The California-based biopharma did not name a temporary replacement for Ehrlich to take over his responsibilities, or if Ehrlich will remain with the company as a consultant to aid in the transition.

News of Ehrlich’s resignation comes less than a month after tarcocimab tedromer, Kodiak’s investigational eye therapy, failed two Phase III studies in neovascular age-related macular degeneration (AMD) and diabetic macular edema (DME).

Tarcocimab tedromer is an anti-VEGF antibody-polymer conjugate designed to maintain potent and therapeutic levels in ocular tissues, lasting much longer than existing anti-VEGF therapies. Aside from AMD and DME, Kodiak was also trialing tarcocimab tedromer in retinal vein occlusion.

The company was hoping to usher tarcocimab tedromer into the market as a strong competitor to Regeneron’s and Bayer’s blockbuster drug Eylea (aflibercept).

Kodiak was evaluating the candidate in the late-stage GLEAM and GLIMMER, two identically designed late-stage trials that evaluated the efficacy, durability and safety of tarcocimab tedromer in 460 and 457 treatment-naïve DME patients, respectively.

The candidate successfully achieved longer treatment intervals, allowing half of patients to receive doses 24 weeks apart, but was unable to demonstrate non-inferior visual acuity gains as compared with Eylea. Kodiak attributed this failure to an “unexpected increase in cataracts” over time in the tarcocimab tedromer arms, according to Kodiak’s Thursday news release.

GLEAM and GLIMMER followed the Phase III DAYLIGHT study, a randomized, double-masked and active comparator-controlled trial that enrolled 557 treatment-naïve patients with wet AMD. Tarcocimab tedromer met the primary endpoint of this study—non-inferior improvements in visual acuity versus Eylea—and treated patients did not see a higher incidence rate of cataracts.

However, the two DME failures led Kodiak to discontinue further development of the candidate.

The company will continue advancing KSI-501, its first-in-class bispecific inhibitor of IL-6 and VEGF, though the late-onset cataract signals in GLEAM and GLIMMER have pushed Kodiak to take a second look at its development program for KSI-501.

KSI-501 is currently in a Phase I study in DME, for which the first patient was treated in April 2023.

Source: BioSpace