AM-111 in the Treatment of Acute Inner Ear Hearing Loss

This phase III study is assessing the drug's safety and is aiming to demonstrate efficacy of intratympanic AM-111 injections in the treatment of severe to profound idiopathic sudden sensorineural hearing loss (ISSNHL). The active pharmaceutical ingredient of AM-111 is the JNK inhibitor (D-JNKI-1), a synthetic peptide consisting of 31 D-amino acids, which acts as a c-Jun N-terminal kinase (JNK) ligand.

Inclusion criteria

• Unilateral ISSNHL with onset within 72 hours prior to study treatment;
• Mean hearing threshold of equal to or worse than (≥) 60 dB averaged across the 3 most affected contiguous air conduction audiometric pure tone frequencies ("pure tone average", PTA);*
• Mean hearing loss of equal to or worse than (≥) 40 dB averaged across the air conducted PTA frequencies compared with the unaffected contralateral ear or reference values from a pre-existing audiogram or ISO 7029;2000 norm values in case of asymmetric hearing prior to the ISSNHL incident;
• Age ≥ 18 and ≤ 65 years on the day of screening;

Other protocol-defined inclusion criteria may apply.

Exclusion criteria

• Bilateral ISSNHL;
• Acute hearing loss from noise trauma, barotrauma or head trauma;
• History of autoimmune hearing loss, radiation-induced hearing loss, endolymphatic hydrops or Menière's disease in the affected ear;
• History of chronic inflammatory or suppurative ear disease or cholesteatoma in the affected ear;
• History of acoustic neuroma or other retrocochlear damage in the affected ear;
• History of otosclerosis in the affected ear;
• Suspected perilymph fistula or membrane rupture in the affected ear;
• Congenital hearing loss;
• History of ISSNHL in the past 2 years;
• Otitis media or otitis externa that is ongoing or ended within 7 days prior to study treatment;

Other protocol-defined exclusion criteria may apply.