Kodiak Sciences will head to regulators with one of the candidates, an anti-VEGF antibody called zenkuda, after the late-stage results.
Two of Kodiak Sciences’ investigational therapies have matched the performance of Regeneron’s blockbuster eye drug Eylea at one year in a late-stage trial.
The biotech’s stock has soared 166% since market open, hitting $86.53 per share about one hour into trading.
The readout centers around Kodiak’s zenkuda—an anti-VEGF antibody biopolymer conjugate also known as tarcocimab tedromer—and tabirafusp-ted, an anti-IL-6 and VEGF trap bispecific also called KSI-501. Both assets are being tested as treatments for wet age-related macular degeneration (wAMD), an eye condition that causes blurred or reduced vision.
With the new data in hand, plus findings from four other late-stage eye disease studies, Kodiak intends on submitting zenkuda for market approval in the last quarter of this year, according to a Monday release. One of the additional studies was in wAMD, two were in diabetic retinopathy and another was for macular edema after retinal vein occlusion.
The latest trial, dubbed DAYBREAK, tested the impact of zenkuda and tabirafusp-ted on vision at one year. The two investigational assets matched aflibercept—Regeneron’s anti-VEGF injection sold as Eylea—meeting the primary goal of the trial. Both candidates also had favorable safety profiles, according to Kodiak.
Specifically, zenkuda quickly demonstrated vision improvement that matched or exceeded Eylea through the loading phase and at the one-year mark, the California biotech said. Treating only as needed, zenkuda was dosed once every six months in 54% of patients following an initial loading period, demonstrating strong durability, Kodiak said. After the loading-dose period, trial participants receiving Eylea were dosed every eight weeks.
“The zenkuda results exceeded my expectations, delivering the clinical profile retina specialists are seeking: rapid vision and anatomic improvements comparable to aflibercept during loading, followed by meaningfully longer intervals between treatment for a majority of patients, while maintaining optimal fluid control,” Charles Wykoff, retina surgeon, ophthalmology professor and deputy chair of ophthalmology at Houston Methodist Hospital, said in Kodiak’s release.
While the biotech intends to file with the FDA later this year for zenkuda across multiple indications, it will also test tabirafusp-ted in an ongoing Phase 3 pivotal program for diabetic macular edema.
