• Trial outcomes provide further evidence for safety of Keyzilen® in chronic intermittent use • Exploratory efficacy results suggest potential benefits of repeating treatment cycles Zug, Switzerland, May 9, 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 key results from AMPACT1 (AM-101 in the Post-Acute Treatment of Peripheral Tinnitus 1), the open-label extension study of the Phase 3 TACTT2 clinical trial. The study provides additional confirmation on the long-term safety of Keyzilen® and suggests the potential for further therapeutic benefits from repeated treatment.
"We are very pleased that the AMPACT1 trial showed good tolerance and safety for Keyzilen® with chronic intermittent use and thus confirms the positive results from the AMPACT2 trial," commented Thomas Meyer, Auris Medical's founder, Chairman and Chief Executive Officer. "In addition, we are glad to see from exploratory efficacy data that the TACTT2 patients who continued into AMPACT1 on average were able to reduce the burden and severity of their tinnitus with repeated treatment."
AMPACT1 is the second of two open-label extension studies with Keyzilen® that were conducted in response to a request from the US Food and Drug Administration (FDA) for safety data from chronic intermittent use of Keyzilen®for up to 12 months. Participants who completed the TACTT2 trial were offered the option to roll over into AMPACT1, while still blinded to the treatment allocation. Patients were given the choice to receive up to three treatment cycles with each cycle comprising three intratympanic administrations of Keyzilen®, followed by a treatment-free observation period of 12 weeks.
TACTT2 and AMPACT1 were primarily conducted in North America. Patients enrolled in TACTT2 within three months from tinnitus onset, i.e. during the acute stage. Of the 316 patients who completed the TACTT2 trial, 257 patients rolled over into AMPACT1 and provided safety data; 228 of these patients provided exploratory efficacy data. At the time of enrollment into AMPACT1, all patients were in the post-acute stage.
The primary safety endpoint of AMPACT1 was the incidence of clinically relevant hearing deterioration five weeks after the start of a treatment cycle. In line with the results from previous trials with Keyzilen®, such incidence was low (6%), with no signs of treatment-related effects. Over the course of AMPACT1, the hearing threshold at the average of 4, 6 and 8 kHz showed only little change. The vast majority of adverse events that were considered related to the study drug or treatment procedure were rated as either mild or moderate in intensity. Three patients experienced a total of four non-fatal, serious adverse events, none of which was considered related to the study drug. Confirming previous data, about 93% of tympanic membranes were already closed at the time of the first follow-up visit.
Exploratory efficacy analyses of AMPACT1 show improvements in the Tinnitus Functional Index (TFI) as well as other tinnitus metrics. The TFI decreased on average by 8.2 points (95% confidence interval 6.2 to 10.1; baseline of 42.7 points) to the last follow-up visit. The more treatment cycles the patients received, the larger the reduction in the TFI was; the difference between three cycles and one cycle reached statistical significance. Similar results were achieved on subjective tinnitus loudness and tinnitus annoyance. In addition, 41% of AMPACT1 participants achieved a reduction in their tinnitus severity (extreme-severe-moderate-mild-none) by at least one grade and 28% reported that their tinnitus severity had improved "much" or "very much" compared to baseline.
Auris Medical expects to announce results from TACTT3, the European placebo-controlled sister trial to TACTT2, in early 2018. The trial has been extended to recruit an additional 60 patients in each of the acute and post-acute strata (i.e. up to three months and between three and six months from onset), and enrollment is ongoing.About Acute Inner Ear Tinnitus Tinnitus is the perception of sound without external acoustic stimulation. Tinnitus of the inner ear may be caused by various injuries to the cochlea, the organ of hearing, such as overexposure to noise. Tinnitus that has been present for less than three months is considered acute, while tinnitus that has been present for over three months is considered chronic. Tinnitus of the inner ear often has a serious impact on ability to sleep, relax or concentrate, which may lead to tiredness, irritation, anxiety or depression. There is no universal standard of care for tinnitus of the inner ear and efficacy of a pharmacological treatment for tinnitus of the inner ear has not yet been conclusively demonstrated.About Keyzilen® (AM-101) Keyzilen® is a small molecule N-methyl-D-aspartate (NMDA) receptor antagonist formulated in a biocompatible gel and delivered by intratympanic injection. Keyzilen® is in development for treatment of acute tinnitus of the inner ear. Emerging evidence suggests that NMDA receptors in the cochlea play a major role in the occurrence of tinnitus following acute injury to the inner ear; e.g. from exposure to excessive noise, infections, disturbances in inner ear blood supply, or the administration of certain ototoxic drugs. Persistent overexpression of NMDA receptors may lead to pathologic excitation of auditory nerve fibers, which in the brain is perceived as tinnitus. The development of Keyzilen® is based on research conducted at the INSERM Institute for Neurosciences, and patents have been granted in more than 40 countries worldwide so far.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 AGtrade on the NASDAQ Global 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, 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 acceptability of the data from AMPACT1 and AMPACT2 in support of a potential new drug application to the FDA and other regulators, the clinical utility of Auris Medical's product candidates, the timing or likelihood of regulatory filings and approvals, Auris Medical'sintellectual 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; the use of proceeds from Auris Medical's recent equity offering and the ability of Auris Medical to finance its operations in the future. 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: Cindy McGee, Head of Investor Relations and Corporate Communications, +41 61 201 1350, email@example.com
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