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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 6-K

 

REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16
OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934

 

For the month of September, 2016

 

 

 

Commission File Number: 001-36582

 

Auris Medical Holding AG

(Exact name of registrant as specified in its charter)

 

Bahnhofstrasse 21

6300 Zug, Switzerland

(Address of principal executive office)

 

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F:

 

Form 20-F

x

   Form 40-F o

 

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1):

 

Yes o   No

x

 

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7):

 

Yes o   No

x

         
         
 
 
 

SIGNATURE

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

 

    Auris Medical Holding AG  
       
       
      By: /s/ Anne Sabine Zoller  
        Name: Anne Sabine Zoller
        Title: General Counsel  

 

Date: September 19, 2016

 

 
 

EXHIBIT INDEX

 

Exhibit Number Description
99.1 Excerpt of AM-101 Safety Profile Presentation presented at AAO-HNSF San Diego 2016.

 

 

Exhibit 99.1

1 What is the safety profile of Intratympanic Injections? • Common procedure in ENT offices • Procedure is generally considered safe and routine ; Some old literature suggests increased risk of TM perforation • Commonly used for local, off - label administration of corticosteroids or gentamicin • Until recently, no drug approved for this route of administration • Limited data on safety available especially when repeat administrations are performed

 
 

2 Safety Data Collected in TACTT2 Trial • Efficacy and Safety of AM - 101 in the T reatment of Ac ute Peripheral T inni t us 2 ( TACTT2) • AM - 101 is a small molecule NMDA receptor antagonist formulated in hyaluronic acid and delivered via an intratympanic injection • Systematic collection of safety data on repeated intratympanic injections • Approximately 1,000 intratympanic injection procedures • >60 secondary and tertiary sites in six countries • US, Canada, Czech Republic, South Korea, Turkey, Israel • Enrollment phase between March 2014 and March 2016

 
 

3 TACTT2 Trial Design Overview • Acute peripheral tinnitus following traumatic cochlear insult (acute noise trauma, barotrauma, surgery trauma) or otitis media • Up to 3 months from onset • Documented tinnitus history

 
 

4 Assessed for eligibility (n=478) Withdrawal by subject (n=9) Lost to follow - up (n=5) Other reasons (n=2) Withdrawal due to AE (n=1) Allocated to AM - 101 (n=204) Received AM - 101 (n=201) / Safety analysis Allocation Analysis Follow - Up Enrollment Excluded (n=135) Randomized (n=343) Patient Enrollment Valid for efficacy analysis (n=196 ) Per protocol analysis (n=167 ) Withdrawal by subject (n=6) Lost to follow - up (n=1) Other reasons (n=2) Withdrawal due to AE (n=1) Allocated to placebo (n=139) Received placebo (n=135) / Safety analysis Valid for efficacy analysis (n=130) Per protocol analysis (n=111 ) 4

 
 

5 Safety Population AM - 101 (n=201) Placebo (n=135) Total (n=336) Age (mean) 43.4 44.2 43.7 Age (range) 18 to 74 20 to 73 18 to 74 Time from tinnitus onset (mean in days) 64.8 64.6 64.7 Average hearing threshold (4, 6 and 8 kHz) 27.4 28.7 28.0 Tinnitus treatment laterality Unilateral 119 76 195 Bilateral 82 59 141 Demographics and Baseline Characteristics 5

 
 

6 Safety Endpoints • Primary: Average hearing deterioration of ≥15 dB from baseline to Day 35 in two contiguous frequencies • 15 dB considered as clinically relevant • Permanent threshold shift from intervention, if any, expected to show at Day 35 • Secondary: • Clinically relevant hearing deterioration from baseline to Day 10 and Day 84 • Difference in occurrence of clinically relevant hearing deterioration from baseline to all post - baseline visits between treated and untreated contralateral ear (unilaterally treated patients only) • Adverse events • Exploratory: • Hematology and biochemistry • Vital signs

 
 

Injection Procedure (Safety Population) 7 0% 20% 40% 60% 80% 100% Posterior- inferior Anterior- inferior Superior quadrants Mixed quadrants Quadrant for Injection AM-101 Placebo 83.0% 0.3% 11.3% 5.4% Treatment approach Tympanopuncture Tympanostomy tube Tympanotomy Different techniques used 0% 5% 10% 15% 20% 25% 30% 35% 40% EMLA Lidocaine Xylocaine Others Mixed used Local Anesthetic Use AM-101 Placebo

 
 

Clinically Relevant Hearing Deterioration 0% 5% 10% 15% 20% Day 10 Day 35 Day 84 Air Conduction AM-101 Placebo P=0.82 P=0.22 0% 5% 10% 15% 20% Day 10 Day 35 Day 84 Bone conduction AM-101 Placebo P=0.55 P=1.00 P=0.33 % of Patients with Hearing Deterioration • No difference between treated and untreated ear in unilateral cases, except for placebo at Day 10 • Essentially no change from baseline to Day 84 at average of 4, 6 and 8 kHz: • +0.56 dB for AM - 101 and +0.23 dB for placebo P=0.18 8

 
 

• All drug - related AEs were mild to moderate • Procedure - related AEs were predominantly transient and mild to moderate • All SAEs were isolated cases and not related to study drug or procedure • Low rate of procedure - related infections • AEs leading to withdrawal: – AM - 101: Subjective worsening of hearing (procedure related) – Placebo: Blockage and discomfort (drug related) Adverse Events 9 Number of Patients n(%) AM - 101 (n=201) Placebo (n=135) Total (n=336) Any AEs 97 (48.3%) 50 (37.0%) 147 (43.8%) TEAEs 90 (44.8%) 46 (34.1%) 136 (40.5%) Drug - related AEs 14 (7.0%) 6 (4.4%) 20 (6.0%) Procedure - related AEs 34 (16.9%) 22 (16.3%) 56 (16.7%) SAEs 5 (2.5%) 1 (0.7%) 6 (1.8%) AEs leading to withdrawal 1 (0.5%) 1 (0.7%) 2 (0.6%) AEs leading to death 0 0 0

 
 

Tympanic Membrane Closure • Rapid closure of tympanic membrane perforation following injection • Data confirmed results from previous Phase 2 trial Closure observed at follow - up visit on: AM - 101 Placebo Day 10 91.7% 93.1% Day 35 99.0% 99.2% Day 84 100.0% 100.0% 10

 
 

Summary of TACTT2 Safety Results • AM - 101 and intratympanic injection procedure were well tolerated • Over course of ~1 ,000 injections, no drug or procedure - related SAEs observed • Comparable drug - and procedure - related AE rate between AM - 101 and placebo • Low occurence of transient procedure - related effects • Closure of tympanic membrane within one week in almost all patients • Primary safety endpoint at Day 35 achieved • Occurrence of clinically relevant hearing deterioration low and not different between treatment groups • Normal variation since no difference to untreated contralateral ear • Repeated intratympanic injections with AM - 101 over 3 - 5 day period are safe and well tolerated 11

 
 

12 Acknowledgements The authors would like to thank all investigators, study staff and patients who participated in the TACTT2 trial