Kodiak's KSI-301 was shown to have sustained benefit and safety in a phase 1a study involving patients with severe DME.
Clinical stage novel therapy biopharmaceutical company Kodiak Sciences will present new data from its KSI-301 clinical study at the American Society of Retina Specialists (ASRS) 2019 Annual Meeting in Chicago, IL, this weekend.
The company—which specializes in novel therapies for common chronic retinal conditions—will present new data on the investigational therapy designed to maintain strong, effective drug levels in the ocular tissues of treated patients, at a rate longer than existing agents.
According to Kodiak, the intent of the investigational anti-vascular endothelial growth factor (anti-VEGF) antibody biopolymer conjugate is to improve real-world outcome results for patients with retinal vascular diseases including age-related macular degeneration (AMD) and diabetic macular edema (DME). Investigators also hope the therapy enables earlier treatment regimen in patients and as a result, a reduced risk of vision loss.
In phase 1a, 12-week trial results shared by Kodiak in December, single ascending dose KSI-301 was associated with improvements in baseline vision, anatomy, or both in 9 patients with severe diabetic macular edema.
Investigators also reported a median best corrected visual acuity (BCVA) improvement of 12.5 eye chart letters, as well as a median central retinal thickness (CRT) on optical coherence tomography (OCT) improvement of 120 microns after 4 weeks of any 3 dose levels of KSI-301.
At trial’s end, single-dose KSI-301 demonstrated no dose-limiting toxicities nor drug-associated adverse events, as well as no signs of intraocular inflammation.
Prior to the new data presentation at ASRS 2019, Kodiak chief executive officer Victor Perlroth, MD, expressed excitement for the investigational drug’s clinical performance.
“The data being presented for the first time at ASRS 2019 from our phase 1b multiple-dose study will address initial safety and efficacy of KSI-301 in patients with treatment naïve wet AMD, diabetic macular edema/diabetic retinopathy and retinal vein occlusion,” Perlroth said in a statement. “We look forward to Dr. (Pravin) Dugel sharing the data for the first time with the retina specialist community from the podium at ASRS.”
The presentation, “Antibody Biopolymer Conjugates: A Novel Scientific Approach and Platform for Extended-Durability Retinal Medicines - First Results from a Phase 1b Proof of Concept Study of KSI-301, an anti-VEGF ABC,” will be presented by Pravin U. Dugel, MD, on Saturday at ASRS 2019.