ZUG, Switzerland, Nov. 13, 2015 (GLOBE NEWSWIRE) -- Auris Medical Holding AG (NASDAQ: EARS ), a clinical-stage company dedicated to developing therapeutics that address important unmet medical needs in otolaryngology, today 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 (ISSNHL; a.k.a. "sudden deafness"). The trial will enroll 255 patients suffering from acute severe to profound hearing loss within 72 hours from ISSNHL 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. The second trial, ASSENT, is expected to start enrolment in North America in the first half of 2016.
"We are very excited to begin enrolling patients in HEALOS", commented Bettina M. Stubinski, Auris Medical's Chief Medical Officer. "Sudden deafness can be a very frightening experience, especially when the hearing loss is severe or profound and accompanied by tinnitus, and chances for complete recovery are low. AM-111 has shown very promising results as an otoprotectant in acute hearing loss, and we expect HEALOS to be a major milestone on our way towards the development of the first specific therapeutic for this condition", she added. Results from HEALOS are expected for the second half of 2017.
About acute inner ear hearing loss
Acute inner ear hearing loss may be the consequence of various insults to the cochlea. It may result e.g. from overexposure to noise, bacterial or viral infections, inflammation, vascular compromise, or a variety of other factors. In acute inner ear hearing loss, sensorineural structures of the inner ear - inner and outer hair cells, neurons - are damaged, as well as other structures such as supporting cells or vascular tissues. The common observation is a temporary increase in hearing thresholds, i.e. hearing loss. Thanks to cellular defenses and intrinsic repair mechanisms, a certain amount of such hearing loss is frequently recovered in the subsequent days and weeks. The remaining hearing loss however is irreversible. Acute inner ear hearing loss may be accompanied by other disorders of the inner ear such as dizziness or tinnitus.
When acute hearing loss develops into permanent hearing loss, it may have chronically debilitating consequences. Hearing loss may have serious impacts 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 for acute inner ear hearing loss with proven efficacy.
About AM-111
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.
AM-111's otoprotective effect has 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. Auris Medical will conduct two pivotal clinical trials (HEALOS and ASSENT) with AM-111 in the treatment of idiopathic sudden sensorineural hearing loss (ISSNHL), which the Company estimates to be the most frequent type of ASNHL. In addition, Auris Medical is preparing a Phase 2 trial with AM-111 in the treatment of surgery-induced hearing loss (REACH).
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 development of treatments for acute inner ear tinnitus (AM-101) and for acute inner ear hearing loss (AM-111) by way of intratympanic injection with biocompatible gel formulations. In addition, Auris Medical is pursuing early-stage research and development projects. The Company was founded in 2003; it is headquartered in Zug, Switzerland.
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 prospectus relating to its Registration Statement on Form F-1, as amended, 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.
Auris Medical contacts: Company: Dr. Thomas Meyer, Chairman and CEO, +41 41 729 71 94, ear@aurismedical.com Investors: Matthew P. Duffy, Managing Director, LifeSci Advisors, 212-915-0685, matthew@lifesciadvisors.com
Auris Medical HEALOS First Patient In http://hugin.info/160190/R/1966692/718263.pdf
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