Auris Medical Announces Publication Related to AM-111 in Peer-Reviewed Scientific Journal

Zug, Switzerland, May 4, 2018 - Auris Medical Holding AG (NASDAQ: EARS), a clinical-stage company dedicated to developing therapeutics that address important unmet medical needs in neurotology, today 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 3 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 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 neurotology. The company has two Phase 3 programs: AM-111 (brimapitide otic gel) for the treatment of acute inner ear hearing loss and Keyzilen® (AM-101; esketamine otic gel) for the treatment of acute inner ear tinnitus. In addition, Auris Medical is developing intranasal betahistine for the treatment of vertigo (AM-125) as well as early-stage research and development projects. 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."

 

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, 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

 

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