Auris Medical completes enrolment in study of drug to treat hearing loss

December 2010

Auris Medical announced today that enrolment has been completed for the first of two dose cohorts in its phase IIb clinical trial with AM-111 for the treatment of acute sensorineural hearing loss (ASNHL). A total of 105 patients were enrolled in the study and received either AM-111 at 2.0 mg/ml or placebo in a single dose intratympanic injection at a ratio of 2:1. The study recruited patients who showed up for treatment within 48 hours from ASNHL onset and whose hearing loss amounted to at least 30 dB in 3 contiguous frequen-cies. Auris Medical is planning to proceed to the second dose cohort shortly.

Thomas Meyer, Auris Medical's founder and Managing Director, commented on the conclusion of the first dose cohort: "Effective treatment of acute sensorineural hearing loss remains an important unmet medical need. We are very pleased to have reached this important milestone in our AM-111 clinical development programme." He added: "AM-111's strong otoprotective effects have been well demonstrated in various animal models, and we are confident that the current study will show its efficacy in humans as well." The phase IIb trial with AM-111 is expected to finish in early 2012.

About acute sensorineural hearing loss

Acute sensorineural hearing loss (ASNHL) or inner ear hearing loss is the consequence of various insults to the cochlea. It may result e.g. from overexposure to noise, bacterial or viral infections, inflammation, vascu-lar compromise, or a variety of other factors. In ASNHL, sensorineural structures of the inner ear - inner and outer hair cells, neurons - are damaged, as well as other structures such as supporting cells or vascular tissues. The common observation is a temporary increase in hearing thresholds, i.e. hearing loss. Thanks to cellular defences and intrinsic repair mechanisms, a certain amount of such hearing loss is frequently re-covered in the subsequent days and weeks. The remaining hearing loss however is irreversible. ASNHL may be accompanied by other disorders of the inner ear such as dizziness or tinnitus.

When ASNHL develops into permanent hearing loss, it may have chronically debilitating consequences. Hearing loss may have serious impacts on professional and personal lives, e.g. through avoidance or with-drawal from social situations, reduced alertness and increased risk to personal safety, impaired memory and ability to learn new tasks, or reduced job performance and earning power. To date, there exists no treatment for ASNHL with proven efficacy.

About AM-111

AM-111 is a cell-permeable peptide that selectively blocks JNK MAPK mediated apoptosis of stress injured hair cells and neurons in the cochlea. Major cochlear stress incidents that may result in irreversible hearing loss include exposure to excessive noise, disturbances of the blood supply, viral or bacterial infections, and exposure to certain ototoxic substances. When administered within a therapeutic time window after the incident, AM-111 can effectively protect cochlear hair cells and neurons that would otherwise undergo apoptosis and be lost forever. AM-111's otoprotective properties have been extensively tested and con-firmed in various animal models so far, including acute acoustic trauma, acute labyrinthitis, surgery trauma, aminoglycoside ototoxicity, semicircular canal injury in otitis media and cochlear ischemia. AM-111 has been granted orphan drug status in both the European Union and the USA for the treatment of acute sen-sorineural hearing loss. The active substance of AM-111 has been in-licensed by Auris Medical from Swiss biotechnology company Xigen S.A.

About Auris Medical