Kodiak Sciences Inc. (Nasdaq: KOD), a biopharmaceutical company focused on developing transformative therapeutics for retinal diseases, announced that the first patients with diabetic retinopathy have been treated in the Phase 3 GLOW2 study of tarcocimab tedromer. This milestone marks a significant advancement in the ongoing research and development efforts aimed at combating retinal diseases.

Key Points

– Phase 3 GLOW2 Study Initiation: Kodiak Sciences begins Phase 3 GLOW2 study, treating the first patients with diabetic retinopathy.

– Extended Dosing Intervals: All patients on investigational therapy will receive tarcocimab with extended dosing intervals, including 6-month dosing.

– Successful GLOW1 Study: The GLOW2 study mirrors the successful GLOW1 study, which showed significant improvements in diabetic retinopathy severity.

– Enrollment Goal: GLOW2 aims to complete patient enrollment by the end of the year.

The GLOW2 study is designed to evaluate the efficacy and safety of tarcocimab tedromer in treatment-naïve patients with diabetic retinopathy. Patients are randomized 1:1 and receive tarcocimab via intravitreal injection at baseline, Week 4, Week 8, Week 20, and Week 44. The primary endpoint is the proportion of eyes improving ≥2 steps on the Diabetic Retinopathy Severity Scale (DRSS) from baseline at Week 48.

“In recent months, competing long-acting retinal therapies in development have posted disappointing treatment and prevention results in diabetic retinopathy,” said Dr. Victor Perlroth, Kodiak’s Chief Executive Officer. “GLOW1 data showed unequivocally that treatment with tarcocimab in extended dosing intervals, including 6-month dosing in all patients, achieved two related but clinically distinct goals: treating existing disease and preventing disease progression.”

If successful, GLOW2 could serve as one of the pivotal studies supporting the marketing authorization application for tarcocimab. This investigational anti-VEGF therapy, built on Kodiak’s proprietary Antibody Biopolymer Conjugate (ABC) Platform, is designed to maintain effective drug levels in ocular tissues for extended periods, potentially improving outcomes for patients with retinal vascular diseases.

Tarcocimab Tedromer: Promising Results in Multiple Studies

Tarcocimab has completed three successful Phase 3 pivotal clinical studies: GLOW1 for diabetic retinopathy, BEACON for retinal vein occlusion, and DAYLIGHT for wet AMD. Across these studies, tarcocimab has demonstrated consistent durability of approximately 6 months for most patients and favorable safety.

Kodiak Sciences is also initiating two additional Phase 3 studies: GLOW2 in diabetic retinopathy and DAYBREAK in wet AMD. The DAYBREAK study will evaluate the efficacy, safety, and durability of tarcocimab and KSI-501, Kodiak’s bispecific conjugate, versus aflibercept.

Dr. Perlroth emphasized the importance of these studies in strengthening tarcocimab’s competitive position and enhancing the regulatory dossier for the program.

The initiation of the Phase 3 GLOW2 study is a critical step for Kodiak Sciences in its mission to transform retinal disease treatment. The promising results from GLOW1 and other Phase 3 studies underscore the potential of tarcocimab to significantly improve patient outcomes. The extended dosing intervals and favorable safety profile make it a compelling option for diabetic retinopathy treatment.

As Kodiak Sciences progresses with GLOW2 and other pivotal studies, the potential for tarcocimab to become a key player in the retinal therapeutics market appears strong. The success of these studies could pave the way for new standards in the treatment of diabetic retinopathy and other retinal diseases.

  anti-VEGF therapy, clinical trial, diabetic retinopathy, Kodiak Sciences, Ophthalmology, Phase 3 GLOW2 study, retinal diseases, tarcocimab tedromer