- TACTT3 Phase 3 trial protocol amended based on analysis of
TACTT2 trial outcomes
- TACTT3 enrollment to be expanded with top-line results expected
in early 2018
- Conference call scheduled for today to discuss development
update
Auris Medical Holding AG (NASDAQ: EARS), a clinical-stage company
dedicated to developing therapeutics that address important unmet
medical needs in otolaryngology, today announced additional
clinical data as well as updates to its development plan for
KeyzilenTM (AM-101) in acute inner ear tinnitus.
Based on insights from the recently completed
TACTT2 trial, the Company is submitting a protocol amendment to
regulatory agencies in Europe for TACTT3, the ongoing second Phase
3 clinical trial. In the amended trial protocol, the change in
Tinnitus Functional Index (TFI) score will be elevated from a key
secondary endpoint to an alternate primary efficacy endpoint.
Certain patient subgroups will be included in confirmatory
statistical testing, and the trial size will be increased to
enhance statistical sensitivity to the effects of treatment.
Top-line results from the expanded TACTT3 trial are now expected in
early 2018. The outcomes from TACTT2 and the regulatory path
forward will be reviewed with the US Food and Drug Administration
in early December 2016.
TACTT2 was a randomized, double-blind,
placebo-controlled trial conducted primarily in North America,
enrolling 343 patients suffering from acute inner ear tinnitus
following traumatic cochlear injury or otitis media. As previously
announced, the trial failed to meet its two co-primary endpoints:
the change in subjective tinnitus loudness (tinnitus loudness
question; TLQ) and the change in tinnitus burden measured by the
TFI from baseline to Day 84 over placebo. However, the TACTT2 trial
data show treatment effects on TFI in favor of KeyzilenTM for
specific subgroups. In the pre-specified subgroup of patients
suffering from tinnitus following otitis media, treatment with
KeyzilenTM resulted in a clinically meaningful and statistically
significant reduction of 14.8 points in the TFI from baseline, as
compared to 6.2 points for placebo (p=0.048). A reduction of 13
points was defined as clinically meaningful by the developers of
the TFI. A trend for improvement was also observed in
active-treated patients who suffered from severe or extreme
tinnitus at baseline with a clinically meaningful reduction in TFI
of 15.5 points as compared to 11.5 points in the placebo group
(p=0.238). Unexpectedly, the TLQ showed a lower sensitivity to
change than the TFI, which the Company believes to be related to
the frequent (daily) rating of tinnitus loudness over an extended
period of time.
"Although we are disappointed that the TACTT2 trial
failed to confirm the efficacy of KeyzilenTM in the overall study
population, we feel very encouraged by the clinically meaningful
reductions in tinnitus burden in two relevant subgroups," commented
Thomas Meyer, founder, Chairman and Chief Executive Officer of
Auris Medical. "New knowledge gained from the TACTT2 trial allows
us to make appropriate adjustments to the TACTT3 trial while we are
still fully blinded to its outcomes. We believe that the measures
outlined today will improve the probability of success of the
TACTT3 trial for the entire study population as well as for key
patient subgroups."
TACTT3, which is being conducted in Europe, is a
randomized, double-blind, placebo-controlled trial in acute and
post-acute inner ear tinnitus following traumatic cochlear injury
or otitis media. So far, the trial enrolled more than 300 patients
during the acute tinnitus stage (Stratum A) and approximately 330
patients during the post-acute tinnitus stage (Stratum B). Under
the amended trial protocol, the change in tinnitus loudness and in
the TFI from baseline to Day 84 will both be alternate primary
efficacy endpoints. Applying the Hochberg procedure, the two
endpoints will be tested for the overall study population as well
as for the subpopulations of patients with otitis media-related
tinnitus or with severe tinnitus at baseline. In order to enhance
the trial's statistical power, 60 additional patients will be
recruited in TACTT3 in each of Stratum A and Stratum B. The Company
expects enrollment to resume in early 2017.
For more information on tinnitus symptoms and the
patient experience, please click on this video link.
Conference Call & Webcast
Information
Auris Medical will host a conference call and
webcast to discuss the KeyzilenTM program update today, October 11,
2016, at 8:00 am Eastern Time (2:00 pm Central European Time). To
participate in this conference call, dial 1-855-217-7942 (USA) or
+1-646-254-3376 (International), and enter passcode 2939516. 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 Acute Inner Ear Tinnitus
Tinnitus, the perception of sound without external
acoustic stimulation, is a symptom common to various ear or other
diseases. Inner ear tinnitus may be provoked by various injuries to
the cochlea, the organ of hearing, such as overexposure to noise or
inflammation. Tinnitus may be transitory; however, it may also
become permanent. Tinnitus of less than three months of duration is
considered acute, while older tinnitus is considered
chronic. Inner ear tinnitus often has a serious impact on the
ability to sleep, relax, or concentrate, and it may lead to
tiredness, irritation, nervousness, despair, frustration, or even
depression. As of today, neither a universal standard of care for
acute inner ear tinnitus, nor a truly proven and effective
treatment method is available.
About Keyzilen TM (AM-101)
KeyzilenTM is a small molecule N-methyl-D-aspartate
(NMDA) receptor antagonist formulated in a biocompatible gel for
intratympanic injection. 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. KeyzilenTM has received fast track
designation from the FDA for the treatment of acute peripheral
(inner ear) tinnitus following traumatic cochlear injury or otitis
media in adults. The development of KeyzilenTM 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 currently focusing
on the Phase 3 development of treatments for acute inner ear
tinnitus (KeyzilenTM; AM-101) and for acute inner ear hearing loss
(AM-111) by way of intratympanic administration with biocompatible
gel formulations. In addition, Auris Medical is pursuing
early-stage research and development projects. The Company was
founded in 2003 and is headquartered in Zug, Switzerland. The
shares of the parent company Auris Medical Holding AG trade 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, the clinical utility of Auris
Medical's product candidates, including the likelihood that the
TACTT3 trial may not meet its endpoints , 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.
Contact: Cindy McGee, Head of Investor Relations
and Corporate Communications, +41 61 201
1350, investors@aurismedical.com
Media contact: David Schull, Russo Partners,
1-858-717-2310, david.schull@russopartnersllc.com
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