Date: 2017-07-05
Type of
information: Completion of patient enrollment
phase: 3
Announcement: completion 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: Bulgaria
Trial
details:
- The HEALOS 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 Europe and Asia and is enrolling patients who are suffering from severe to profound idiopathic sudden sensorineural hearing loss within 72 hours from onset. Patients are randomized to receive AM-111 0.4 mg/mL, 0.8 mg/mL or placebo in a 1:1:1 ratio; oral corticosteroids are given as reserve therapy in case of insufficient hearing recovery by Day 7. The primary efficacy endpoint for the trial is the improvement of pure tone hearing thresholds from baseline to Day 28. (NCT02561091)
- HEALOS is the first of two pivotal trials in Auris Medical's Phase 3 clinical development program for AM-111. The second Phase 3 trial, ASSENT, is set to enroll approximately 300 patients. Auris Medical expects to announce top-line results from the ASSENT trial in the second half of 2018.
Latest
news:
- • On July 5, 2017, Auris Medical announced that it has completed patient enrollment in the Phase 3 HEALOS clinical trial of AM-111 in idiopathic sudden sensorineural hearing loss, also known as sudden deafness. Top-line results from the HEALOS trial are expected in the fall of 2017.
- • On September 9, 2016, Auris Medical announced that it has reached the midpoint for enrollment in the HEALOS Phase 3 clinical trial of AM-111 in idiopathic sudden sensorineural hearing loss. HEALOS has now enrolled more than 125 patients out of the target of 255 patients. Auris Medical expectsto report top-line results in the second half of 2017.
- • On November 13, 2015, Auris Medical announced enrolment of the first patient into the pivotal HEALOS clinical trial with AM-111. HEALOS will evaluate the efficacy, safety and tolerability of single dose intratympanic injections of AM-111 in the treatment of idiopathic sudden sensorineural hearing loss. The trial will enroll 255 patients suffering from acute severe to profound hearing loss within 72 hours from idiopathic sudden sensorineural hearing loss onset. They will be randomized to receive either AM-111 at 0.4 mg/mL or 0.8 mg/mL or placebo.
- Auris Medical benefited for the design of the HEALOS trial from multiple discussions with European and US regulatory agencies. The primary efficacy endpoint for the trial is the improvement of pure tone hearing thresholds from baseline to Day 28 at the average of the three most affected contiguous test frequencies. HEALOS will be conducted in several European and Asian countries, involving more than 70 sites. It is the first of two pivotal trials in Auris Medical's phase 3 clinical development program with AM-111.
Is
general: Yes
