Auris Medical Announces Randomization of First Patient in AM-125 Phase 2 Trial in Acute Vertigo

Hamilton, Bermuda, July 30, 2019 (GLOBE NEWSWIRE) -- Auris Medical Holding Ltd. (NASDAQ: EARS), a clinical-stage company dedicated to developing therapeutics that address important unmet medical needs in neurotology and central nervous system disorders, today announced that the first patient has been randomized in its “TRAVERS” Phase 2 trial of AM-125, the Company’s investigational drug for the treatment of acute vertigo. 

The TRAVERS trial will enroll a total of 138 patients who suffer from acute vertigo following surgical removal of a vestibular schwannoma, a tumor growing behind the inner ear. In Part A of the trial, five ascending doses of AM-125 or placebo, administered three times daily over a total of four weeks, will be tested in 50 patients. In addition, oral betahistine 48 mg will be tested in 16 patients under open-label conditions for reference. Based on an interim analysis, two doses will be selected and tested in an estimated 72 patients in Part B of the trial. The TRAVERS trial is being conducted in six European countries and Canada.

“After securing approvals from the numerous regulatory authorities and ethics committees involved, we are excited to start patient enrollment into the TRAVERS trial,” commented Thomas Meyer, Auris Medical’s founder, Chairman and CEO. “With AM-125, we seek to improve and accelerate vestibular recovery so that patients are back in control of their balance sooner, thus improving their quality of life. Betahistine, the active substance of AM-125, is known to promote vestibular compensation, and we expect intranasal delivery to provide superior efficacy compared to oral administration.”

As previously announced, Auris Medical’s second development project with intranasal betahistine, AM-201, recently completed enrollment for a Phase 1b proof-of-concept trial in the prevention of antipsychotic-induced weight gain with top line data expected for later in the third quarter of 2019.

The Company will provide its first-half 2019 results and a business update on August 15, 2019 at 8:00am Eastern Time (2:00pm Central European Time). To participate in this conference call, dial (toll free) or , and enter passcode 2228118. A live webcast of the conference call can be accessed in the Investor Relations section of the Auris Medical website at . A replay will be available approximately two hours following the live call.

About AM-125

Intranasal betahistine is being developed under project code AM-125 for the treatment of acute vertigo. Betahistine acts as agonist at the H₁ and as antagonist at the H₃ histamine receptors and has been shown to increase cochlear, vestibular and cerebral blood flow, facilitate vestibular compensation and inhibit neuronal firing in the vestibular nuclei. Betahistine for oral administration is approved in about 115 countries, with the US being a notable exception, for the treatment of vertigo and Meniere’s disease. However, due to rapid and extensive metabolism, bioavailability of oral betahistine is very low in humans, which limits the treatment’s clinical utility. Intranasal administration results in significantly higher betahistine concentrations in blood, which in turn is expected to result in higher efficacy and more rapid onset of action.

About Auris Medical

Auris Medical is a biopharmaceutical company dedicated to developing therapeutics that address important unmet medical needs in neurotology and CNS disorders. The company is focused on the development of intranasal betahistine for the treatment of vertigo (AM-125) and for the prevention of antipsychotic-induced weight gain and somnolence (AM-201). These projects have gone through two Phase 1 trials and moved into proof-of-concept studies in 2019. In addition Auris Medical has two Phase 3 programs under development: Sonsuvi^® (AM-111) for acute inner ear hearing loss and Keyzilen^® (AM-101) for acute inner ear tinnitus. The Company was founded in 2003 and is headquartered in Hamilton, Bermuda with its main operations in Basel, Switzerland. The shares of Auris Medical Holding Ltd. 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 facts 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”, or the negative of these terms or 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 ability to pursue strategic partnering and non-dilutive funding for its Phase 3 programs, the results of Auris Medical’s review of strategic options and the outcome of any action taken as a result of such review, 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 for the year ended December 31, 2018, and in Auris Medical's other filings with the SEC, which are available free of charge on the Securities Exchange Commission's website at: Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those indicated. All forward-looking statements and all subsequent written and oral forward-looking statements attributable to Auris Medical or to persons acting on behalf of Auris Medical are expressly qualified in their entirety by reference to these risks and uncertainties. You should not place undue reliance on forward-looking statements. 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.

Investor contact:

Joseph Green

Edison Group for Auris Medical

646-653-7030

 

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