Auris Medical initiating phase IIb clinical trial with AM-111

Editor: Here's the latest press release from the folks at Auris Medical. Their AM-111 drug will be entering Phase Iib clinical trials for the treatment of sudden deafness.

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Auris Medical initiated its second clinical trial with AM-111, its investigational drug for the treatment of acute sensorineural hearing loss. The primary objective of the double blind, randomised, placebo-controlled phase IIb trial with dose escalation is to evaluate the efficacy of AM-111 administered by intratympanic injection to patients suffering from acute acoustic trauma or sudden deafness. The primary endpoint of the study is the hearing improvement compared to placebo by day 7. Secondary objectives of the study are the evaluation of AM-111's efficacy at 3, 30 and 90 days following injection as well as the further assessment of the treatment's safety and local tolerance. A first clinical trial in 2006 showed that AM-111 was well tolerated and safe, and provided first indications of a therapeutic benefit.

The phase IIb study will enroll patients with unilateral sensorineural hearing loss in the first 48 hours following onset of sudden deafness or acute acoustic trauma. Their hearing loss must be at least 30 dB in 3 contiguous frequencies. Those patients whose hearing recovers by less than 10 dB by day 7 may at their request receive glucocorticoids as a reserve therapy. The clinical trial with AM-111 will be conducted in Germany and, subject to approval by the competent authority and ethics committees, also in a second European country. The study will involve almost 20 clinical sites and be directed by Professor Markus Suckfüll as International Coordinating Investigator.

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, vascular 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 withdrawal 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. Unfortunately, there exists no standard therapy with proven efficacy for ASNHL so far.

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 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 confirmed in various animal models so far, including acute acoustic trauma, acute labyrinthitis, surgery induced acoustic trauma (cochlear implant electrode insertion) and aminoglycoside ototoxicity. AM-111 has been granted orphan drug status in both the European Union and the USA for the treatment of acute sensorineural hear-ing loss. The active substance of AM-111 has been in-licensed by Auris Medical from Swiss biotechnology company Xigen S.A.

About Auris Medical