Biopharmaceutical company Kodiak Sciences Inc disclosed on Friday the completion of enrollment of patients with diabetic macular edema under its phase 1 safety and tolerability study of of KSI-301 in the US.
Under the phase 1 safety and tolerability study of of KSI-301 in the US, the first patient was dosed on 12 July 2018 and last patient in was dosed on 13 August 2018.
The company added 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 and is the first of Antibody Biopolymer Conjugate, or ABC, products to reach the clinic.
This open label, single ascending dose phase 1 trial has enrolled 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. 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.
In conjunction, 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, concluded the company.
Diamyd Medical granted US FDA Fast Track designation for Diamyd diabetes treatment
Aprecia names new chief commercial officer
Insulet's Omnipod 5 integration with Abbott FreeStyle Libre 2 Plus Sensor secures CE Mark approval
Kyowa Kirin enrols first subject in phase two tivozanib eye drops (KHK4951) clinical trial
Novo Nordisk to boost manufacturing capacity with acquisition of three fill-finish sites
Breye Therapeutics commences phase 1b/2a danegaptide clinical trial
DexCom Inc breaks ground on new manufacturing facility in Ireland
VibroSense Dynamics AB secures provisional patent for chemotherapy-induced nerve damage prediction
Innovent Biologics signs collaboration agreement with Sanegene Bio USA
Japan approves GSK's filing for Arexvy vaccination for at-risk adults
Arecor Therapeutics plc extends collaboration with Eli Lilly
OptiBiotix Health partners with Ravenswood for SlimBiome distribution in Australia and New Zealand
Boehringer Ingelheim granted European approval of oral liquid medication for feline diabetes