Auris Medical Achieves Midpoint for Enrollment in Phase 3 Trial of AM-111 in Sudden Deafness

ZUG, Switzerland, Sept. 9, 2016 -- Auris Medical Holding AG (EARS), a clinical-stage company dedicated to developing therapeutics that address important unmet medical needs in otolaryngology, today 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, or ISSNHL, which is also known as sudden deafness.

 

"We are pleased to continue making progress with the Phase 3 development of AM-111 as the first specific therapeutic for acute inner ear hearing loss," commented Thomas Meyer, Auris Medical's founder, Chairman and Chief Executive Officer. "HEALOS has now enrolled more than 125 patients out of the target of 255 patients, and we expect to report top-line results in the second half of next year, in line with previous guidance."

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 ISSNHL 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.

 

HEALOS is the first of two pivotal trials in Auris Medical's Phase 3 clinical development program for AM-111. The second trial, ASSENT, was initiated in June 2016 and 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 United States, 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 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 background therapy. The primary efficacy endpoint for the trial is the improvement of pure tone hearing thresholds from baseline to Day 91.

 

About Acute Inner Ear Hearing Loss

 

Acute injury to the cochlea, e.g., from overexposure to noise, bacterial or viral infections, inflammation or vascular compromise may result in damage to inner ear hair cells and neurons and acute hearing loss. Thanks to cellular defenses and intrinsic repair mechanisms, a certain amount of hearing loss can be recovered in the subsequent days and weeks following the insult. However, the remaining hearing loss is irreversible. Acute inner ear hearing loss may be accompanied by other disorders of the inner ear such as dizziness or tinnitus, and if it develops into permanent hearing loss, it may have chronically debilitating consequences. Hearing loss may have a serious impact on professional and personal lives, e.g. through avoidance or withdrawal from social situations, reduced alertness and increased risk to personal safety, impaired memory and ability to learn new tasks, or reduced job performance and earning power. To date, there exists no treatment with proven efficacy for acute inner ear hearing loss.

 

About AM-111

 

AM-111 contains the synthetic peptide D-JNKI-1 (D-stereoisomer of c-Jun N-terminal Kinase Inhibitor 1), a cell-penetrating inhibitor of 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 the apoptosis of cochlear hair cells and neurons as well as in inflammatory responses. By blocking JNK, AM-111 protects stress-injured cochlear cells and helps to prevent or reduce chronic hearing loss. AM-111's otoprotective effects have been demonstrated in various animal models of cochlear stress, including acute acoustic trauma, acute labyrinthitis (inflammation), drug ototoxicity (aminoglycosides), bacterial infection, cochlear ischemia and cochlear implantation trauma. Clinically, AM-111 has been evaluated in two completed trials and is currently being tested in two pivotal Phase 3 trials. It is administered intratympanically in one single dose. AM-111 has orphan drug designation from both the US Food and Drug Administration and the European Medicines Agency.

 

About Auris Medical

 

Auris Medical is a Swiss biopharmaceutical company dedicated to developing therapeutics that address important unmet medical needs in otolaryngology. The Company is currently focusing on the Phase 3 development of treatments for acute inner ear tinnitus (KeyzilenTM; AM-101) and for acute inner ear hearing loss (AM-111) by way of intratympanic administration with biocompatible gel formulations. In addition, Auris Medical is pursuing early-stage research and development projects. The Company was founded in 2003 and is headquartered in Zug, Switzerland. The shares of the parent company Auris Medical Holding AG trade on the NASDAQ Global Market under the symbol "EARS."

 

Forward-looking Statements

 

This press release may contain statements that constitute "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements are statements other than historical fact and may include statements that address future operating, financial or business performance or Auris Medical's strategies or expectations. In some cases, you can identify these statements by forward-looking words such as "may," "might," "will," "should," "expects," "plans," "anticipates," "believes," "estimates," "predicts," "projects," "potential," "outlook" or "continue," and other comparable terminology. Forward-looking statements are based on management's current expectations and beliefs and involve significant risks and uncertainties that could cause actual results, developments and business decisions to differ materially from those contemplated by these statements. These risks and uncertainties include, but are not limited to, the timing and conduct of clinical trials of Auris Medical's product candidates, the clinical utility of Auris Medical's product candidates, the timing or likelihood of regulatory filings and approvals, Auris Medical's intellectual property position and Auris Medical's financial position, including the impact of any future acquisitions, dispositions, partnerships, license transactions or changes to Auris Medical's capital structure, including future securities offerings. These risks and uncertainties also include, but are not limited to, those described under the caption "Risk Factors" in Auris Medical's Annual Report on Form 20-F and future filings with the Securities and Exchange Commission. Forward-looking statements speak only as of the date they are made, and Auris Medical does not undertake any obligation to update them in light of new information, future developments or otherwise, except as may be required under applicable law. All forward-looking statements are qualified in their entirety by this cautionary statement.

 

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