Kodiak Sciences completes enrollment for KSI-301 safety study in retinal disease

Kodiak Sciences, a California-based biotechnology company, has recently completed patient enrollment for a phase 1 safety and tolerability study of its innovative retinal disease drug, KSI-301. This study marks a significant step in the clinical development of KSI-301, which is being tested primarily on patients with diabetic macular edema in the United States.

The phase 1 trial is an open label, single ascending dose study designed to evaluate the safety and establish a maximum tolerated dose of KSI-301. This anti-VEGF (Vascular Endothelial Growth Factor) biological agent, known for its extended durability, is administered directly into the eye and targets several retinal vascular diseases, including neovascular age-associated macular degeneration (wet AMD) and diabetic eye diseases.

The first participant in the trial was dosed on July 12, with the last patient receiving their dose on August 13. The administration of KSI-301 was led by Dr. Pravin Dugel of Retinal Consultants of Arizona, along with other prominent investigators such as Dr. Sunil Patel, Dr. David Boyer, and Dr. Richard McDonald. Kodiak Sciences reported that the drug has been well-tolerated in all subjects to date, with no significant ocular inflammation or drug-related adverse events observed at any administered dose. The dose escalation process reached a maximal tested dose of 5.0mg.

Building on the outcomes of the phase 1 study, Kodiak Sciences plans to initiate a series of phase 1b and phase 2 trials to further explore the efficacy of KSI-301 across different conditions, including wet AMD and diabetic retinopathy.

The advancement of KSI-301 into later stages of clinical trials is a promising development in the treatment of retinal diseases. The drug’s innovative approach could potentially offer a new therapeutic option for patients suffering from these debilitating conditions, improving both vision and quality of life.

As Kodiak Sciences progresses with the clinical development of KSI-301, the medical community and patients alike watch with hopeful anticipation. This drug could represent a significant breakthrough in the treatment of retinal diseases, offering new hope for those affected by such conditions.