Company shares fell over 50% after two late-stage studies failed to demonstrate vision improvements in patients with diabetes macular edema.
Pictured: Person undergoing an eye exam/iStock, Jacob Wackerhausen
Kodiak Sciences shares fell over 50% on Monday after the company announced that its late-stage biologic failed to sufficiently improve the vision of patients with diabetes macular edema and that it would not be pursuing this program any further.
While the studies largely supported the safety of tarcomab tedromer, with only rare cases of intraoculer inflammation and no cases of intraocular inflammation with vasculitis or vascular occlusion, the studies noted an unexpected increase in the number of cataracts in patients over time.
“Kodiak’s initial evaluation suggests that this contributed meaningfully to the failure of each study,” Kodiak CEO Victor Perlroth said in a statement.
But the primary driver for dropping the drug was the efficacy data. Tarcimab tedromer performed roughly 60% as well as aflibercept in both trials. Patients in the GLEAM trial treated with tarcimab tedromer gained an average of 6.4 eye chart letters, compared to 10.3 for patients treated with aflibercept. The GLIMMER trial saw tarcimab tedromer patients gain an average of 7.4 eye chart letters, versus 12.2 on aflibercept.
“In summary, we are deeply disappointed with the GLEAM and GLIMMER outcome,” Perlroth said.
The news sent Kodiak shares tumbling, according to reporting by Reuters: shares fell over 50% in premarket trading on Monday. Company shares at market close on Friday were valued at about $381 million.
The company has another compound, KSI-501, in the pipeline for vision loss caused by retinal vascular diseases
Connor Lynch is a freelance writer based in Ottawa, Canada. Reach him at lynchjourno@gmail.com.