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Auris Medical Reports New Data Highlighting Superior Bioavailability of AM-125 Compared to Oral Betahistine

February 7, 2018 at 9:11 AM EST
  • Single dose animal study demonstrates 5 to 35 times higher bioavailability of intranasal betahistine relative to oral betahistine
  • Bioavailability of intranasal betahistine in humans estimated to be 20 to 40 times higher relative to oral betahistine

Zug, Switzerland, February 7, 2018 - Auris Medical Holding AG (NASDAQ: EARS), a clinical-stage company dedicated to developing therapeutics that address important unmet medical needs in neurotology, today reported new data on the pharmacokinetics of AM-125, its investigational drug for the intranasal treatment of vertigo. The results show markedly higher blood plasma concentrations when betahistine administered intranasally rather than orally. Oral betahistine is currently marketed in about 115 countries world-wide and one of the most frequently prescribed treatments for vestibular disorders.

Non-clinical pharmacokinetics

In a single-dose pharmacokinetic study in Beagle dogs betahistine concentrations were determined in blood plasma following intranasal administration of the compound at doses up to 120 mg, oral administration up to 48 mg/kg and intravenous administration at 0.44 mg/kg. The absolute bioavailability reached 27 to 82% with intranasal betahistine and 2 to 6% with oral betahistine. The relative bioavailability of intranasal betahistine against oral betahistine was in a range of 5 to 35 times. Overall, the pharmacokinetic profile of intranasal betahistine was similar to the one of intravenous betahistine. The study results confirm and complement those from an earlier single- and repeated-dose in a smaller number of Beagle dogs. In both studies, intranasal betahistine was well tolerated.

Human pharmacokinetics

Additional human pharmacokinetic data were generated through the comparison of outcomes from an earlier single dose Phase 1 clinical trial with intranasal betahistine up to 40 mg with those from an independent Phase 1 clinical trial with oral betahistine at 3 x 48 mg/day.[1] The relative bioavailability with intranasal administration was 20-40 times higher than with oral administration.

"We are very pleased to see the superior bioavailability of intranasal betahistine confirmed further based on animal and human study data," commented Thomas Meyer, Auris Medical's founder, Chairman and Chief Executive Officer. "Although oral betahistine in many cases is the drug of choice for treating vestibular disorders, it is also well known that the drug is not used most effectively with current standard oral doses due to its rapid metabolization. We believe that the intranasal route offers significant additional benefits in terms of efficacy and tolerability. We plan to bring this new treatment option to patients in key markets, including in the US where the compound currently is not approved."

In a next step, Auris Medical is planning to test intranasal betahistine in a second phase 1 clinical trial to determine the maximum tolerated dose with single and repeated dosing and to generate additional data on the relative bioavailability compared to oral betahistine. The study is expected to start enrolling healthy volunteers towards the end of the first quarter of 2018; results are expected to become available by mid-year.

About Auris Medical

Auris Medical is a Swiss biopharmaceutical company dedicated to developing therapeutics that address important unmet medical needs in neurotology. 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 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, 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 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.

Investor contact: Daniel Ferry, LifeSci Advisors, LLC, 1-617-535-7746, investors@aurismedical.com  




[1] The overall design of that trial are described in Barak et al. (2016), Journal of Psychopharmacology 30(3): 237-241. The maximum approved total daily oral dose for betahistine is 48 mg.


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