Zug, Switzerland, August 30, 2018 - Auris Medical Holding AG (NASDAQ: EARS), a clinical-stage company dedicated to developing therapeutics that address important unmet medical needs in neurotology and mental disorders supportive care, announced today feedback from a Type C meeting with the U.S. Food and Drug Administration (FDA) related to the development plan and regulatory pathway for AM-111, its investigational treatment for sudden sensorineural hearing loss.
The Type C meeting had been requested by the Company following the results of the HEALOS phase 3 trial. The results showed, based on a post-hoc analysis, a clinically meaningful and nominally significant improvement in hearing for the AM-111 0.4 mg/mL group compared to placebo in the subpopulation of patients with acute profound hearing loss. These patients were initially completely deaf or almost deaf on the affected ear and normally would have faced a particularly poor prognosis for hearing recovery.
The FDA reviewed the Company's proposed concept for a placebo-controlled pivotal trial with AM-111 0.4 mg/mL in patients suffering from acute profound hearing loss. The trial protocol builds to a large extent on the design and outcomes from HEALOS and also incorporates specific feedback provided by the European Medicines Agency (EMA) earlier this year. In a written response the FDA endorsed the proposed choice of primary and secondary efficacy endpoints, the safety endpoints, as well as the planned sample size and statistical methodology. In addition, the FDA provided important guidance on the regulatory path forward.
"We very much appreciate the FDA's feedback and guidance for our AM-111 program", commented Thomas Meyer, Auris Medical's founder, chairman and CEO. "We are very pleased to be aligned with the FDA and EMA on key design aspects for the planned phase 3 trial and look forward to working with the agencies as we continue to develop AM-111 as a potential first-in-class treatment for sudden sensorineural hearing loss." As previously announced, the Company intends to move the AM-111 development program forward through partnering.
About Sudden Sensorineural 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. Sudden sensorineural 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.
AM-111 is being developed in a biocompatible gel formulation for the treatment of sudden 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. 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. AM-111 has orphan drug designation from both the US Food and Drug Administration and the European Medicines Agency, and it was granted Fast Track status by the FDA.
About Auris Medical
Auris Medical is a Swiss biopharmaceutical company dedicated to developing therapeutics that address important unmet medical needs in neurotology and mental disorders supportive care. The company is focused on the development of intranasal betahistine for the treatment of vertigo (AM-125) and for the treatment of antipsychotic-induced weight gain and somnolence (AM-201). This program is currently in Phase 1. In addition Auris Medical has two Phase 3 programs under development: AM-111 for sudden sensorineural hearing loss and Keyzilen® (AM-101) for acute inner ear tinnitus. The Company was founded in 2003 and is headquartered in Zug, Switzerland. The shares of Auris Medical Holding AG trade on the NASDAQ Capital Market under the symbol "EARS."
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, Auris Medical's need for and ability to raise substantial additional funding to continue the development of its product candidates, the timing and conduct of clinical trials of Auris Medical's product candidates will not meet its endpoints , 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.
Company contact: Hernan Levett, Chief Financial Officer, +41 61 201 1350