Clinical Trials

Date: 2016-06-17

Type of information: Initiation of patient enrollment

phase: 3

Announcement: initiation of patient enrollment

Company: Auris Medical (Switzerland)

Product: AM-111

Action mechanism:

peptide/kinase inhibitor. AM-111 contains the synthetic peptide 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. D-JNKI-1 is formulated in a biocompatible and fully biodegradable gel. It is administered by a single dose intratympanic injection into the middle ear. From there the drug diffuses through the round window membrane into the cochlea.
JNK is a signal transmitting enzyme that regulates a number of important cellular activities, including activation of genes encoding inflammatory molecules or promoting cell death (apoptosis). JNK is activated following various types of cochlear insults (stress) that may lead to acute inner ear hearing loss. AM-111 enters cells and binds to JNK, thereby inhibiting activation of transcription factors such as c-jun and c-fos. This in turn prevents JNK mediated apoptosis and inflammatory response, which could otherwise result in irreversible loss of hair cells and cochlear neurons. AM-111 supports natural recovery processes and helps to prevent or reduce chronic hearing loss.

Disease: idiopathic sudden sensorineural hearing loss

Therapeutic area: Otorhinolaryngology

Country: USA

Trial details:

The ASSENT trial is a randomized, double-blind, placebo-controlled study evaluating the efficacy, safety and tolerability of single-dose intratympanic administration of AM-111. The trial is being conducted in the U.S., Canada and South Korea and is set to enroll approximately 300 patients who are suffering from severe to profound ISSNHL within 72 hours from onset. Patients will be randomized to receive AM-111 0.4 mg/mL, 0.8 mg/mL or placebo in a 1:1:1 ratio; oral corticosteroids will be given as background therapy. The primary efficacy endpoint for the trial is the improvement of pure tone hearing thresholds from baseline to Day 91. (NCT02809118)

Latest news:

• On June 17, 2016, Auris Medical announced it has initiated patient enrollment in the ASSENT Phase 3 clinical trial of AM-111 in idiopathic sudden sensorineural hearing loss. ASSENT is the second of two pivotal trials in Auris Medical's Phase 3 clinical development program for AM-111. The first trial, HEALOS, which is being conducted in several European and Asian countries, was initiated in November 2015 and is enrolling approximately 255 patients. In the Phase 2 clinical trial program, patients with severe to profound hearing loss who were treated with AM-111 0.4 mg/mL showed a statistically significant improvement in hearing threshold, speech discrimination and a higher rate of complete tinnitus remission compared with placebo.