AM 111 reviewed in Hearing Research as an investigational treatment for acute inner ear hearing loss.-Auris Medical Holding AG. journal

Auris Medical Holding AG a clinical-stage company dedicated to developing therapeutics that address important unmet medical needs in neurotology, announced the publication of an article reviewing the mechanism of action, pharmacokinetics and therapeutic applications of AM 111, its investigational treatment for acute inner ear hearing loss. The peer-reviewed article "Preclinical and clinical otoprotective applications of cell-penetrating peptide D-JNKI-1 (AM 111)" was published in Hearing Research, one of the leading journals in the otorhinolaryngology field.

"The publication summarizes the extensive body of non-clinical and clinical data on AM 111 that have been accumulating over more than 15 years of research", commented Thomas Meyer, Auris Medical's founder, Chairman and CEO. "Numerous studies have demonstrated AM 111's strong otoprotective effects across various types of acute cochlear injury, ranging from traumatic conditions such as sound overexposure or cochlear implantation to non-traumatic conditions such as acute inflammation, infection, vascular disturbances or ototoxic medications."

AM 111 is being developed in a biocompatible gel formulation for the treatment of acute sensorineural hearing loss with a single-dose administration into the middle ear. Its active substance is brimapitide (also known as D-JNKI-1, D-stereoisomer of c-Jun N-terminal Kinase Inhibitor 1), a cell-penetrating peptide which inhibits the JNK stress kinase. JNK is activated following various types of cochlear insults (stress) that cause acute inner ear hearing loss and plays a key role in apoptosis of sensory cells as well as in inflammatory responses.

In the recent HEALOS Phase III trial, a post-hoc analysis showed a clinically meaningful and nominally significant hearing improvement in patients treated with AM 111 0.4 mg/mL compared against placebo in the subpopulation with profound acute hearing loss. Based on this outcome, Auris Medical is discussing the accumulated safety and efficacy data and the regulatory path forward with key health authorities. AM 111 has orphan drug designation from both the FDA and the European Medicines Agency.