Auris Medical is developing A&M-111 for the treatment of acute inner ear (sensorineural) hearing loss (ASNHL). AM-111 contains brimapitide, or D-JNKI-1 (D-stereoisomer of c-Jun N-Terminal Kinase Inhibitor 1), an inhibitor of the JNK stress kinase coupled to an intracellular transporter. AM-111 is formulated in a biocompatible and fully biodegradable gel and administered in a single dose intratympanic injection into the middle ear. From there the drug diffuses through the round window membrane into the cochlea.
Auris Medical is conducting two pivotal clinical trials with AM-111 in the treatment of ISSNHL: the HEALOS trial ((Efficacy and Safety of AM-111 in the Treatment of Acute Inner Ear Hearing Loss) Europe/Asia, initiated in Q4/2015) and the ASSENT trial (Efficacy and Safety of AM-111 as Acute Sudden Sensorineural Hearing Loss Treatment; North
AM-111 was safe and well tolerated in the Phase 2 clinical trial. There were no statistically significant differences in the occurrence of clinically relevant hearing deterioration in the treated ear