Kodiak Sciences announced that enrollment of patients in the company’s phase 1 safety and tolerability study has been completed. First patient in was dosed on July 12, 2018 and last patient in was dosed on August 13, 2018.
KSI-301 is the first of Kodiak’s pipeline of Antibody Biopolymer Conjugate, or ABC, products to reach the clinic. KSI-301 is an investigational agent for the treatment of patients with retinal vascular diseases including neovascular age related macular degeneration (wet AMD) and diabetic eye disease. KSI-301 is an intravitreally administered anti-VEGF biological agent with an extended durability profile.
The phase 1 trial is being conducted in the USA as an open label, single ascending dose study enrolling patients with diabetic macular edema. The primary objectives of the phase 1 study are to evaluate ocular and systemic safety and to establish a maximum tolerated dose of KSI-301. To date, the study drug has been safe and well tolerated in all subjects with no signs of ocular inflammation or drug related adverse events at any dose. Dose escalation culminated in a maximal tested dose of 5.0mg. The first patient was dosed by Dr. Pravin Dugel of Retinal Consultants of Arizona. Other patients were dosed by participating investigators Dr. Sunil Patel, Dr. David Boyer, and Dr. Richard McDonald.
The phase 1 study is a point of departure for a series of proposed phase 1b and phase 2 studies for KSI-301 in wet AMD and diabetic retinopathy.