- HEALOS trial did not meet primary efficacy endpoint in
overall study population
- Clinically and statistically significant improvement in
subpopulation of patients with profound acute hearing loss
- Conference call scheduled for today to review HEALOS data,
provide a business update and present third quarter 2017 financial
results
Zug, Switzerland, November 28, 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 top-line results
from the HEALOS Phase 3 clinical trial of AM-111 in severe to
profound sudden deafness. Overall, the HEALOS trial did not meet
the primary efficacy endpoint of a statistically significant
improvement in hearing from baseline to Day 28 compared to placebo
for either active treatment groups. However, a post-hoc analysis of
the subpopulation with profound acute hearing loss revealed a
clinically and statistically significant improvement in the AM-111
0.4 mg/mL treatment group.
"For many patients, sudden deafness is a very
frightening experience and may result in chronic hearing loss as
well as a significantly reduced quality of life," commented Hinrich
Staecker, MD, PhD, Professor, Department of Otolaryngology Head and
Neck Surgery, University of Kansas Medical Center, Kansas City.
"This is a challenging condition especially in case of profound
hearing loss, where the ear is almost or completely deaf and the
prognosis for recovery tends to be poor. I am pleased to see that
in the HEALOS trial AM-111 showed promising therapeutic benefits in
this group of patients who are most in need of them."
" The read-out from the HEALOS Phase 3 trial
with AM-111 in acute inner ear hearing loss is a major milestone
for Auris," added Thomas Meyer, Auris Medical's founder, Chairman
and Chief Executive Officer. "Although the trial did not meet our
expectations for the primary efficacy endpoint in the overall study
population, we are very pleased to see the clinically and
statistically significant treatment effect in the profound hearing
loss subpopulation. Considering the high unmet medical need, we
look forward to discussing with regulatory agencies the next steps
on our path to bringing AM-111 to patients. On behalf of our team
at Auris Medical, I would like to extend my sincere appreciation to
the patients and investigators involved in this trial."
The HEALOS trial is a randomized, double-blind,
placebo-controlled study evaluating the efficacy, safety and
tolerability of AM-111. The trial was conducted in several European
and Asian countries and enrolled 256 patients suffering from severe
to profound sudden deafness within 72 hours from onset. Patients
were randomized in a 1:1:1 ratio to receive a single dose of either
AM-111 0.4 mg/mL, AM-111 0.8 mg/mL or placebo, administered into
the middle ear.
The hearing improvement at the three worst
affected contiguous test frequencies at Day 28 was 38.4 dB for
patients in the AM-111 0.4 mg/mL group compared to 33.4 dB for the
placebo group (p=0.226). For patients in the AM-111 0.8 mg/mL group
the improvement was 36.6 dB (p=0.448). Post-hoc analysis in the
subpopulation of patients with profound hearing loss[1] (n=98)
showed an improvement at Day 28 of 42.7 dB in the AM-111 0.4 mg/mL
group vs. 26.8 dB in the placebo group, which was statistically
significant (p=0.0176). The improvement was 37.3 dB in the AM-111
0.8 mg/mL group (p=0.126). In addition, AM-111 was well tolerated
and the primary safety endpoint was met. There was no significant
difference in the occurrence of clinically relevant hearing
deterioration between either of the active treated groups and the
placebo group at Day 28.
Based on the findings from the HEALOS trial,
Auris Medical has concluded that the very similar design of the
currently ongoing ASSENT trial is no longer adequate for testing
AM-111. Therefore the ASSENT trial will be terminated early.
Conference Call & Webcast
Information
Auris Medical will host a conference call and
webcast to review the top-line results from the HEALOS trial,
present third quarter 2017 financial results and provide a general
business update today, November 28, 2017, at 8:00 am Eastern Time
(2:00 pm Central European Time). To participate in this conference
call, dial 1-877-280-1254 (USA) or +1-646-254-3365 (International),
and enter passcode 4997511. A live webcast of the conference call
will be available in the Investor Relations section of the Auris
Medical website at www.aurismedical.com and a replay of the
conference call will be available following the live call.
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
Media contact: David Schull, Russo Partners LLC,
1-858-717-2310, david.schull@russopartnersllc.com
[1] Commonly defined as hearing threshold of 90 dB or
higher.
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