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.

The California-based company was testing tarcocimab tedromer, a novel antibody-polymer conjugate developed by the company for the treatment of vision loss. Kodiak had three Phase III trials: DAYLIGHT, GLEAM, and GLIMMER. The DAYLIGHT trial investigated the safety and efficacy of tarcocimab tedromer in a high-intensity dosing regimen for patients with wet age-related amcular degeneration (AMD). Not only was the drug “safe and well tolerated,” but it met the clinical target of “non-inferior visual acuity gains” relative to aflibercept, sold commercially as Eylea and Zaltrap.

But the next two Phase III trials, GLEAM and GLIMMER, were far less promising. These were identical studies investigating the safety, durability, and efficacy of tarcocimab tedromer for patients with DME.

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 caused by concurrent inflammation or abnormal angiogenesis, with its Phase I trial now underway.

Source: bioSpace.com