Kodiak discontinues development of tarcocimab
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Key takeaways:
- The GLEAM and GLIMMER studies failed to meet their primary efficacy endpoints.
- There was an increase in cataracts over time in the tarcocimab arms of both studies.
Kodiak Sciences is discontinuing development of tarcocimab tedromer, citing results of the GLEAM and GLIMMER phase 3 studies in diabetic macular edema, according to a press release.
“A successful efficacy, durability and safety outcome in both GLEAM and GLIMMER was the basis of our regulatory and clinical development strategy for tarcocimab,” Kodiak CEO Victor Perlroth, MD, said in the release.
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The identically designed randomized controlled studies failed to meet their primary efficacy endpoints of showing noninferior visual acuity gains for tarcocimab dosed every 8 to 24 weeks after three monthly loading doses compared with aflibercept dosed every 8 weeks after five monthly loading doses. Additionally, there was an increase in cataracts over time in the tarcocimab arms of both studies.
Perlroth said the imbalance of cataract adverse events that emerged in the final third of the study (19% in the tarcocimab group vs. 9% in the aflibercept group) was the likely driver of the drug failing to achieve best corrected visual acuity noninferiority to aflibercept.
The timing or number of tarcocimab doses did not seem to correlate with the development of cataracts. In addition, in the phase 3 DAYLIGHT study in wet age-related macular degeneration, patients received a median of 12 tarcocimab doses over 1 year and experienced fewer cataract events (3%) than in the aflibercept group (5%).
“We are deeply disappointed with the GLEAM and GLIMMER outcome,” Perlroth said in the release. “We recognize the risks inherent to innovative drug development and expect to continue to work towards the goal of translating our capabilities and substantive cash position into value for our stakeholders.”
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