Kodiak matches Regeneron's Eylea in macular edema phase 3, lighting Beacon of hope after flop

Kodiak Sciences has bounced back from the failure of its eye disease drug candidate, noting that it has matched Regeneron and Bayer’s blockbuster Eylea in a phase 3 trial of macular edema due to retinal vein occlusion (RVO).

California-based Kodiak is developing tarcocimab, also known as KSI-301, in the belief that the dosing schedule of existing treatments prevents real-world patients from realizing the benefits seen in clinical trials. The biotech acknowledges that existing anti-VEGF agents improve and maintain vision when dosed per the label. However, real-world studies have shown patients are “over-extended” between doses, according to Kodiak, resulting in minimal visual gains that fade as the months and years pass. 

Kodiak applied its antibody polymer conjugate platform to the perceived problem, resulting in a prospect that investigators gave every two months after initial loading shots in the phase 3 Beacon trial. Despite subjects in the tarcocimab cohort receiving four doses, compared to the six administered to Eylea recipients, the drug candidate performed comparably to Regeneron and Bayer’s incumbent product. 

The non-inferiority margin was 4.5 eye chart letters. Across the entire population, the study reported a p value of 0.0243. Focusing on the subpopulation of patients with branch RVO resulted in a 0.0004 p value. Kodiak’s statement lacks a p value for the subpopulation of patients with central RVO.

Kodiak is yet to share other important information. On the safety front, the biotech said tarcocimab was safe and well tolerated, adding that the rates of intraocular inflammation in the investigational treatment and control arms were 1.4% and 0.4%, respectively. No participants suffered vasculitis or retinal arterial occlusion events.

The full data, which Kodiak plans to share next month, will form part of a multi-front push to get the drug candidate to market. Kodiak is running two studies in diabetic macular edema that will serve as the primary basis for a licensing application, if successful. The biotech will then use single studies in other indications including RVO to open up additional opportunities. 

Shares in Kodiak rose as high as 40% to around $13.60 in premarket trading in the immediate wake of the data drop. Even so, the stock remains well down on the $50-plus price it commanded before the failure of a wet age-related macular degeneration study in February.