Zug, Switzerland, Feb. 24, 2017 - Auris Medical Holding AG (NASDAQ: EARS), a clinical-stage company dedicated to developing therapeutics that address important unmet medical needs in otolaryngology, today announced that the US Food and Drug Administration (FDA) has granted Fast Track designation for AM-111 in the treatment of acute sensorineural (inner ear) hearing loss (ASNHL).
"We are very pleased to have received Fast Track designation for AM-111 from the FDA," commented Thomas Meyer, Auris Medical's founder, Chairman and Chief Executive Officer. "The designation recognizes that acute sensorineural hearing loss can be a serious condition with a significant impact on day-to-day functioning. It may develop into irreversible, chronic hearing loss with debilitating consequences, yet there is no therapy available for ASHNL that is approved or that has shown clear evidence of therapeutic benefits."
Auris Medical is currently evaluating AM-111 in two Phase 3 clinical trials. The first is the HEALOS trial, which is being conducted in several European and Asian countries. HEALOS aims to enroll approximately 255 patients with severe to profound idiopathic sudden sensorineural hearing loss. Auris Medical expects to complete enrollment in the second quarter of 2017 and announce top-line results from this trial in the third quarter of 2017.
The second is the ASSENT trial, which is being conducted in the US, Canada and South Korea. ASSENT aims to enroll approximately 300 patients with severe to profound idiopathic sudden sensorineural hearing loss. Auris Medical expects to announce top-line results from this trial in the second half of 2018.
"We welcome the opportunity to work closely with the FDA to expedite the development of AM-111 and look forward to reporting our first top-line results from the Phase 3 program in the third quarter," commented Andrea Braun, Auris Medical's Head of Regulatory and Quality Affairs.
The Fast Track program was created by the FDA to facilitate the development and expedite the review of new drugs that are intended to treat serious conditions and fill an unmet medical need. The program's purpose is to get important new drugs to the patient earlier. A drug that receives Fast Track designation is granted more frequent access to the FDA to review the drug's development plan and may become eligible for priority review if relevant criteria are met. Additionally, Fast Track designation allows the sponsor to submit parts of the New Drug Application (NDA) for review on a rolling basis as data become available.
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 are no treatments with proven efficacy for acute inner ear hearing loss.
AM-111 contains the synthetic peptide brimapitide (also called 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 (FDA) and the European Medicines Agency as well as Fast Track designation from the FDA.
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 focused on the Phase 3 development of treatments for acute inner ear hearing loss (AM-111) and for acute inner ear tinnitus (Keyzilen®; AM-101) by way of intratympanic administration with biocompatible gel formulations. In addition, Auris Medical is pursuing intranasal betahistine for Meniere's disease and vestibular 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 Global 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, prevailing market conditions, whether the Company will consummate the offering of shares and warrants on the expected terms, or at all, the satisfaction of closing conditions related to the offering and risks related to the application of the net proceeds, if any, from the offering. There can be no assurance that the Company will be able to complete the offering at the anticipated size or on the anticipated terms, or at all. In any event, the Company may continue to need additional funding and may be unable to raise capital when needed, which could force the Company to delay, reduce or eliminate its product development programs or commercialization efforts. Other risks and uncertainties relating to the Company's business include the timing and conduct of clinical trials of Auris Medical's product candidates, including the likelihood that the TACTT3 clinical trial with Keyzilen® 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, in Auris Medical's Report on Form 6-K filed on November 10, 2016 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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