Nicox SA, an international ophthalmology company, announced that the first patient has been screened in the Whistler phase 3b clinical trial investigating the dual mechanism of action (nitric oxide and prostaglandin analog) of NCX 470 in intraocular pressure (IOP) lowering. NCX 470, a novel nitric oxide (NO)-donating bimatoprost eye drop, is our lead product candidate in phase 3 clinical development for IOP lowering in patients with open-angle glaucoma or ocular hypertension.
“The model we are using to investigate the effects on aqueous humor outflow is well established and we are pleased to be working with one of the experts in this field, Dr Arthur Sit at the Mayo Clinic. The data from this trial is expected to provide further evidence of the dual mechanism of action of NCX 470 as we should be able to tease out parameters related to how the nitric oxide and the prostaglandin analog components of NCX 470 function," said Doug Hubatsch, EVP, chief scientific officer of Nicox.
The Whistler phase 3b trial will enroll ~20 healthy volunteers with ocular hypertension in a double-masked, placebo-controlled study which will investigate the action of NCX 470 on aqueous humor parameters including trabecular meshwork outflow and episcleral venous pressure.
Each subject will participate in the trial for ~8 days and will provide insight into the mechanism of action of NCX 470. The trial is expected to take approximately 1 year to complete.
Nicox Corporate Status Update
The company is currently funded until the end of June 2024, exclusively on the basis of the development of NCX 470.
The company is pursuing licensing discussions which could extend the cash runway. In parallel, the company is exploring multiple strategic options and is also discussing with its creditors to restructure its debt.