Clinical trial news : Kodiak Sciences has completed enrollment of patients for a phase 1 safety and tolerability study to evaluate its retinal disease drug KSI-301.
The California-based biotech company, which is focused on developing therapies for retinal diseases, said that the phase 1 trial for KSI-301 being held in the US is an open label, single ascending dose trial featuring patients with diabetic macular edema.
KSI-301, which is an anti-VEGF biological agent with an extended durability profile that is administered into the eye, is the first product from Kodiak Sciences’ pipeline to enter into clinical development.
The antibody biopolymer conjugate is being developed by Kodiak Sciences for the treatment of retinal vascular diseases patients including those with neovascular age associated macular degeneration (wet AMD) and diabetic eye disease.
The primary goals of KSI-301’s phase 1 study are to assess ocular and systemic safety and to determine a maximum tolerated dose of the retinal disease drug.
While the first patient in the phase 1 study of the retinal disease drug was dosed on 12 July, the last patient was dosed on 13 August.
Kodiak Sciences revealed: “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 US biotech company further said that so far, the investigational retina disease treatment has been safe and well tolerated in all subjects without any signs of ocular inflammation or drug linked adverse events at any dose. It also said that dose escalation reached a maximal tested dose of 5.0mg.
The phase 1 study of the investigational retinal disease drug is a point of departure for a series of planned phase 1b and phase 2 trials for KSI-301 across wet AMD and diabetic retinopathy, said Kodiak Sciences.