Auris Medical Announces Results of Pre-IND Meeting With FDA For AM-201 Program in Olanzapine-Induced Weight Gain
20 Novembro 2018 - 12:20PM
Zug, Switzerland, November 20, 2018 - Auris
Medical Holding AG (NASDAQ: EARS), a clinical-stage company
dedicated to developing therapeutics that address important unmet
medical needs in neurotology and mental health supportive care,
today announced the results of its pre-Investigational New Drug
(pre-IND) meeting with the United States Food & Drug
Administration (FDA), where the FDA addressed the Company's
questions and provided guidance on its AM-201 program with
intranasal betahistine for the prevention of olanzapine-induced
weight gain.
In its written response, the FDA supported the
planned conduct of a multiple dose Phase 1 trial with AM-201
administered to healthy subjects in combination with olanzapine to
evaluate the pharmacokinetics, pharmacodynamics, and safety, and to
establish proof-of-concept. Further, the FDA endorsed weight gain
normalized to baseline body weight versus placebo as reasonable
primary efficacy endpoint for a subsequent Phase 2 trial. The
Agency deemed the 505(b)(2) pathway appropriate for the AM-201
program as the Company intends to rely on part of its future
submission dossier on existing data from other parties and
sources.
"We are very pleased with the outcomes of the
pre-IND meeting with the FDA as it provided important confirmation
and guidance for our AM-201 development plans," commented Thomas
Meyer, Auris Medical's founder, Chairman and CEO. "Following this
milestone, we look forward to moving ahead with our development
program and to continuing our work towards the development of an
effective and safe treatment for the prevention of
antipsychotic-induced weight gain."
The Company plans to initiate a Phase 1
pharmacokinetic/pharmacodynamic study in the first quarter of 2019
to evaluate AM-201 in the prevention of olanzapine-induced weight
gain. The randomized double blind placebo controlled
proof-of-concept trial will be conducted in a European country and
enroll 50 healthy volunteers who will receive either AM-201 or
placebo concomitantly with olanzapine over four weeks. Doses will
be escalated in five steps. Following the read-out from the study,
the Company expects to file the IND application for AM-201 later in
2019.
About Auris Medical
Auris Medical is a Swiss biopharmaceutical
company dedicated to developing therapeutics that address important
unmet medical needs in neurotology and mental health supportive
care. The company is focused on the development of intranasal
betahistine for the treatment of vertigo (AM-125) and for the
treatment of antipsychotic-induced weight gain and somnolence
(AM-201). This program is currently in Phase 1. In addition Auris
Medical has two Phase 3 programs under development: Sonsuvi®
(AM-111) for acute inner ear hearing loss and Keyzilen® (AM-101)
for acute inner ear tinnitus. 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 facts 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", or the negative of these terms or 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 ability to pursue
strategic partnering and non-dilutive funding for its Phase 3
programs, the results of Auris Medical's review of strategic
options and the outcome of any action taken as a result of such
review, the timing and conduct of clinical trials of Auris
Medical's product candidates, 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 for the year ended December 31, 2017, and in Auris
Medical's other filings with the SEC, which are available free of
charge on the Securities Exchange Commission's website at:
www.sec.gov. Should one or more of these risks or uncertainties
materialize, or should underlying assumptions prove incorrect,
actual results may vary materially from those indicated. All
forward-looking statements and all subsequent written and oral
forward-looking statements attributable to Auris Medical or to
persons acting on behalf of Auris Medical are expressly qualified
in their entirety by reference to these risks and uncertainties.
You should not place undue reliance on forward-looking statements.
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.
Investor contact: Joseph Green / Andrew GibsonEdison
Advisors for Auris Medical646-653-7030 / 7719jgreen@edisongroup.com
/ agibson@edisongroup.com
Or
investors@aurismedical.com
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