Auris Medical Initiating Clinical Trial with Tinnitus Drug
We’ve been following Auris Medical’s drugs for the prevention and reversal of noise-induced hearing loss. It turns out that they also have a drug that is intended to treat inner ear tinnitus. Here’s the story!
Auris Medical initiated its first clinical trial with AM-101, its investigational drug for the treatment of inner ear tinnitus. The primary objective of the double blind, randomised, placebo-controlled trial with dose esca-lation is to evaluate the safety of intratympanically delivered AM-101 in patients suffering from tinnitus following acute noise trauma. The secondary objective of the study is a preliminary evaluation of the poten-tial therapeutic benefit of AM-101. Patients whose tinnitus set in less than three months ago and proved to be refractory to a first-line treatment with glucocorticoids will be enrolled in a maximum of 4 dose cohorts. The clinical trial with AM-101 will be performed at the ENT departments of four clinics of the German Bundeswehr (Ulm, Berlin, Hamburg, Koblenz) with Professor Heinz Maier, MD, acting as lead investigator.
Tinnitus, the perception of sound without external acoustic stimulation, is a very common ear disorder. European population studies estimate 7% to 14% of the population have talked with their physician about tinnitus, while potentially disabling tinnitus occurs in approximately 1% to 2.4% of people (Vesterarger, 1997). Tinnitus may be short and transitory; however, it may also become permanent and seriously impact the ability to sleep, relax, or to concentrate, or lead to tiredness, irritation, nervousness, despair, frustration, or depression. Until now, there exists neither a universal standard of care for tinnitus, nor a truly proven, effective treatment method.
In most cases, tinnitus is associated with hearing loss and originates within the inner ear. Inner ear tinnitus may be provoked by exposure to excessive noise such as in the case of acute or repeated acoustic trauma, sudden deafness, anoxia / ischemia, the administration of certain ototoxic drugs or various other inner ear injuries.
AM-101 is a small molecule that selectively blocks NMDA receptors in the cochlea. Based on research con-ducted at the INSERM Institute for Neurosciences of Montpellier, France, NMDA receptors can provoke ab-errant activity of the auditory nerve which is perceived as tinnitus. NMDA receptors do not seem to be in-volved in fast excitatory neurotransmission which is essential for hearing, but may be activated due to some excitotoxic incident such as noise trauma or sudden deafness. It could be shown in behavioural and electro-physiological models that local administration of the NMDA antagonist AM-101 to animals suffering from tinnitus effectively suppressed the perception of the “phantom sound”. The development of AM-101 was supported by Oséo ANVAR, the French agency for the financing and support of small and mid-sized busi-ness enterprises.
Auris Medical AG, Hauptstrasse 16, CH-3186 Düdingen, www.aurismedical.com Laboratoires Auris SAS, CEEI Cap Alpha, Avenue de l’Europe, FR-34940 Montpellier Cedex 09 Auris Medical Inc., 211 East Ontario Street, Chicago, IL 60611, USA
About Auris Medical
Auris Medical is a Swiss-French biotechnology company developing specific pharmaceutical compounds for the prevention or treatment of inner ear disorders, an area of great unmet medical need. Around the world, many million people are suffering permanently from severe hearing loss and / or tinnitus, still lacking truly effective and safe treatments for their disorders. Auris Medical is currently focusing on the development of treatments for inner ear tinnitus (AM-101) and for acute sensorineural hearing loss (AM-111).