Inotek starts dosing of patients in trabodenoson trial

Trabodenoson, which is the company’s lead clinical candidate, is being investigated to reduce intraocular pressure.

About 335 patients diagnosed with primary open-angle glaucoma (POAG) or ocular hypertension (OHT) will participate in the MATRx-1 trial, which will assess the efficacy, safety and tolerability of trabodenoson over three months of treatment.

The primary endpoint will be the reduction of intraocular pressure (IOP) as compared to the placebo treatment arm.

The study will feature a timolol 0.5% arm to validate the sensitivity of the patient population. The trial is expected to be completed in 2016, with top-line results anticipated in the fourth quarter.

Inotek Pharmaceuticals chief medical officer Rudolf Baumgartner said: "Based on the encouraging Phase 2 results as well as guidance from the U. S. Food and Drug Administration (FDA), our team has formalized plans for our Phase 3 program to support a New Drug Application (NDA) for trabodenoson in glaucoma.

"If approved, trabodenoson — with its potential for once daily dosing and a mechanism that may compliment currently available glaucoma medications — has potential as a valuable treatment option for physicians managing the IOP of patients with this disease."

Trabodenoson, is a first-in-class selective adenosine mimetic which was developed in Inotek’s laboratories. It is designed to restore the eye’s natural pressure control mechanism.

Inotek plans to undertake a fixed-dose combination of trabodenoson with latanoprost. The company is evaluating the potential for selective adenosine mimetics to address optic neuropathies and other degenerative retinal diseases.