Editor: You may remember Auris Medical as one of the companies that is working on medications to prevent and treat noise-induced hearing loss. Now they’re also testing a medication to treat tinnitus. Here’s the story!
Auris Medical completed enrolment of patients for its first clinical trial with AM-101, its investigational drug for the treatment of inner ear tinnitus. A total of 24 patients suffering from tinnitus following acute noise trauma or sudden deafness were administered either AM-101 or placebo by single dose intratympanic injection. Their tinnitus had set in less than three months before treatment and proven to be refractory to a first-line treatment with glucocorticoids.
The primary objective of the double blind, randomised phase I/II trial with dose escalation is to evaluate the safety of intratympanically delivered AM-101 in patients. The secondary objective of the study is a preliminary evaluation of the potential therapeutic benefit of AM-101. The clinical trial with AM-101 is involving four study sites in Germany with Professor Heinz Maier, MD, acting as lead investigator. It will be concluded in two months with the last patient completing the 60 day follow-up period.
AM-101 is a small molecule that selectively blocks NMDA receptors in the cochlea. Based on research conducted at the INSERM Institute for Neurosciences of Montpellier, France, NMDA receptors can provoke aberrant activity of the auditory nerve which is perceived as tinnitus. NMDA receptors do not seem to be involved 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 electrophysiological 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 business enterprises.
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).