Basel, Switzerland — Auris Medical announced that enrollment has started for its phase II US clinical trial with AM-101 for the treatment of acute inner ear tinnitus.
The study will enroll a total of 24 patients for further evaluation of the optimum dosing regimen for AM-101, as well as to generate additional pharmacokinetic data.
AM-101 contains a small molecule that selectively blocks N-methyl-D-aspartate (NMDA) receptors in the cochlea. Prior research suggests that NMDA receptors in the cochlea play a major role in the occurrence of tinnitus following inner ear excitotoxicity, which may be triggered by, for example, exposure to excessive noise, disturbances in inner ear blood supply, barotrauma, migration of pathogens from the inflamed middle ear into the inner ear, noise/vibration trauma resulting from middle ear surgery, or the administration of certain ototoxic drugs.
Consequently, patients wishing to enroll in the trial must have their tinnitus triggered by an incident of acute noise trauma, sudden deafness, otitis media, inner ear barotraumas, or middle ear surgery that occurred not more than 3 months ago.
Those chosen for the trial will receive either the AM-101 intratympanic injection at 0.81 mg/ml or a placebo in a single or triple dose injection.
The company expects the recruitment for the US trial to be completed before the end of 2011.
The first clinical trial with AM-101 has already provided the first indications of therapeutic efficacy. In addition to the current US clinical trial, a large double-blind, randomized, placebo-controlled phase IIb clinical trial with AM-101 is under way in Germany, Belgium, Poland, and the Netherlands.
In addition to AM-101, Auris Medical is also developing AM-111, a pharmaceutical treatment for acute sensorineural hearing loss.
SOURCE: Auris Medical