- Further analyses from HEALOS Phase 3 clinical trial support
AM-111's otoprotective effects in patients with profound acute
hearing loss
- Clinically and statistically significant improvement in hearing
coupled with improvement in word recognition
- Significant reduction in risk of persisting profound hearing
loss
- Conference call and webcast with slides, 8:00 am Eastern Time
today to provide update on AM-111 development program, including
discussion of unmet medical need by KOL
Auris Medical Holding AG (NASDAQ:EARS), a clinical-stage company
dedicated to developing therapeutics that address important unmet
medical needs in otolaryngology, today announced further clinical
results from the HEALOS Phase 3 clinical trial that investigated
AM-111 in the treatment of acute inner ear hearing loss and
provided an update on the AM-111 development program. While the
HEALOS trial had not met the primary efficacy endpoint in the
overall study population, post-hoc analyses of top-line data
revealed a clinically and statistically significant hearing
improvement with AM-111 from baseline to Day 28 in the
subpopulation of patients with profound hearing loss (n=98). The
AM-111 0.4 mg/mL treatment group showed a mean improvement of 42.7
dB vs. 26.8 dB in the placebo group (p=0.0176). The improvement was
37.3 dB in the AM-111 0.8 mg/mL group (p=0.126). AM-111 was well
tolerated and the primary safety endpoint was met.
AM-111 treated patients had a lower incidence of no
hearing improvement
Further analyses on the basis of the full data set provide
additional confirmation of and support for AM-111's otoprotective
effects in the profound acute hearing loss subpopulation. Patients
treated with AM-111 0.4 mg/mL showed a statistically significantly
lower incidence of no hearing improvement[1] compared to
placebo by Day 91 (11.4 vs. 38.2%, risk ratio 0.30, p=0.012). They
also had a lower incidence of no marked hearing
improvement[2] (28.6 vs. 50.0%, risk ratio 0.57, p=0.087). In
addition, the significant improvement in pure tone hearing in the
AM-111 0.4 mg/mL group was coupled with superior improvement in
speech discrimination as the score of correctly recognized words
improved by 49.2 percentage points to Day 91 compared to 30.4
percentage points in the placebo group (p=0.062).
"These new data from the HEALOS trial are promising,
demonstrating a clinically meaningful hearing improvement in those
patients with profound hearing loss," commented Hinrich Staecker,
MD, PhD, Professor, Department of Otolaryngology Head and Neck
Surgery, University of Kansas Medical Center, Kansas City.
"Profound sudden deafness can have a major impact on patients'
cognitive and auditory function as well as quality of life. It has
a poor prognosis, frequently with little or no hearing recovery,
and there are no effective treatments. If approved, AM-111 has the
potential to address the unmet need for novel therapeutics which
can improve hearing during the acute stage of profound sudden
deafness and reduce the substantial risk of severe life-long
hearing impairment."
Treatment benefit in patients with acute hearing loss
consistent with prior Phase 2 data
The results from the profound acute hearing loss subgroup in
HEALOS are broadly in line with those observed in the same
subpopulation in the prior Phase 2 clinical trial with AM-111 (n=12
for AM-111 0.4 mg/mL and n=10 for placebo). Pooling the data from
the two trials shows that hearing improved in the active group by
13.9 dB and 14.5 dB over the placebo group at Days 28 and 91, which
is clinically and statistically significant (p=0.017 and 0.020,
respectively). The relative risk ratio for no improvement at Day 91
was statistically significant at 0.39 (incidence 14.9 vs. 38.6%,
p=0.016).
The Company expects data from a further 31 patients who enrolled
in the ASSENT trial with profound acute hearing loss towards the
end of the first quarter of 2018. ASSENT is being terminated early
in order to avoid the need for substantial protocol changes and
interruptions of enrollment pending feedback from health
authorities on the regulatory pathway. The Company plans to discuss
the accumulated safety and efficacy data and the regulatory pathway
with the FDA and EMA in the second quarter of 2018. The data will
also be submitted for peer review publication and presentation at a
medical meeting in 2018.
"We are very pleased to see further evidence of AM-111's
efficacy in the profound hearing loss patients in the HEALOS
trial," stated Thomas Meyer, Auris Medical's founder, Chairman and
Chief Executive Officer. "The superior improvement in word
recognition provides additional support for AM-111's positive
impact on auditory function; the significant reduction in the risk
of no improvement shows another otoprotective aspect in this
challenging condition. Lastly, the similarity of outcome patterns
in the HEALOS and the Phase 2 trial provides further confirmation
for AM-111's therapeutic benefits. We remain dedicated to bringing
AM-111 to patients suffering from this orphan disease and look
forward to discussing the path forward with the regulatory
agencies."
About the HEALOS 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.
Conference Call & Webcast Information
Auris Medical will host a conference call and webcast with
slides to review the unmet medical need in sudden deafness and
currently available treatment options and to present the AM-111
development program update in more detail today, January 4, 2018,
at 8:00 am Eastern Time (2:00 pm Central European Time). To
participate in this conference call, dial 1-800-281-7973 (USA) or
+1-646-828-8156 (International), and enter passcode 2284504. 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
[1] Defined as less than 15 dB according to Siegel's
criteria.
[2] Defined as less than 30 dB.
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