- Auris Medical's (EARS +0.9%) development plan for Orphan Drug-designated AM-111 includes two pivotal clinical trials in idiopathic (cause unknown) sudden sensorineural hearing loss ((ISSNHL)), which is the most frequent type of acute sensorineural hearing loss (ASNHL).
- The first trial, called HELIOS, will commence in Q3 and will enroll ~255 patients in Europe and Asia. The second trial, called ASSENT, will be based in the U.S. and commence enrollment in Q1 2016. Both groups will receive a single dose of AM-111 (either 0.4 mg/Ml or 0.8 mg/mL) or placebo. The number of subjects will be comparable with HELIOS. Patients in ASSENT may receive a course of oral corticosteroids as background therapy.
- The company is preparing a third Phase 2 trial, called REACH, that should commence in Q3 2016. In this study, patients with residual hearing who are undergoing cochlear implant surgery will receive AM-111 intraoperatively.
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AM-111 is a biodegradable gel that is administered in a single dose intratympanic injection into the middle ear. From there, the drug diffuses through the round window membrane into the cochlea. Its active ingredient is a synthetic peptide that inhibits the JNK stress kinase coupled to an intracellular transporter.
- In animal models of cochlear stress, AM-111's protective effects have been demonstrated in acute acoustic trauma, acute labyrinthitis, drug ototoxicity, bacterial infection, cochlear ischemia and cochlear implant trauma.