Auris Medical Completes Acquisition of AM-125 Assets
July 20 2017 - 8:01AM
Auris Medical Holding AG (NASDAQ: EARS), a clinical-stage company
dedicated to developing therapeutics that address important, unmet
medical needs in otolaryngology, today announced that it has
completed its acquisition of various assets related to intranasal
betahistine from Otifex Therapeutics Ltd. The assets, which
comprise preclinical and clinical data as well as intellectual
property rights, have been fully transferred to Auris Medical with
the closing of the transaction. They form the basis for the
development of AM-125, an intranasal formulation of betahistine for
the treatment of Meniere's disease and other vestibular disorders.
In addition to the Otifex transaction, Auris Medical obtained from
an undisclosed party the right to use certain proprietary
preclinical and clinical data that will support the AM-125
development program and future regulatory filings.
"We are pleased to have efficiently assembled a
package of relevant data to support the development of intranasal
betahistine, a program with the potential to deliver significant
clinical benefits to patients with vestibular disorders," commented
Thomas Meyer, Auris Medical's founder, Chairman and Chief Executive
Officer. "Next, we plan to discuss the development strategy with
U.S. and European regulatory agencies, with the goal of initiating
the second Phase 1 trial of AM-125 in the fourth quarter of this
year. We are targeting a U.S. investigational new drug (IND)
submission in the first quarter of 2018 and would expect to proceed
to a Phase 2 proof-of-concept trial following regulatory
clearance."
In a previous Phase 1 trial, intranasal betahistine
demonstrated good tolerance and significantly higher blood
plasma concentrations when compared to data reported with oral
betahistine. In addition, a 14-day study in beagle dogs
demonstrated that intranasal delivery was well tolerated with
repeated dosing. The second Phase 1 clinical trial of AM-125 is
planned to evaluate single- and multiple-ascending doses in healthy
subjects. The study will determine the maximum tolerated dose
following intranasal administration and assess pharmacokinetics in
blood plasma. The study outcomes will inform dose selection and
regimen for a subsequent Phase 2 proof-of-concept trial.
About Meniere's Disease and Vertigo
Meniere's disease is a chronic disorder of the
inner ear characterized by episodes of vertigo (sensation of
feeling off balance), ringing in the ears (tinnitus), hearing loss,
and fullness in the ear. According to the National Institute of
Deafness and Other Communication Disorders, there are more than
600,000 American adults currently diagnosed with Meniere's disease
and no therapies are currently approved by the U.S. Food and Drug
Administration. Vertigo refers to symptoms resulting from
dysfunction within the body's system of balance, including the
misperception of movement or dizziness. Data from the U.S. National
Health and Nutrition Examination Survey suggest that as many as 69
million American adults have experienced some form of vestibular
disorder.[1]
[1] Agrawal Y, Carey JP, Della Santina CC,
Schubert MC, Minor LB. Disorders of balance and vestibular function
in US adults. Arch Intern Med. 2009;169(10):938-944.
About AM-125 (intranasal betahistine) for
Vestibular DisordersAuris Medical is developing AM-125, an
intranasal formulation of betahistine, for the treatment of
Meniere's disease and other vestibular disorders. Betahistine is a
small molecule drug that acts as a histamine H1-receptor agonist
and a H3-receptor antagonist, approved for use by oral
administration in more than 115 countries worldwide. The compound
has demonstrated the ability to increase cochlear, vestibular and
cerebral blood flow, improve vestibular compensation and the
ability to inhibit neuronal firing in the vestibular nuclei.
Intranasal delivery of AM-125 is intended to bypass the effects of
first-pass metabolism found with oral delivery of betahistine,
potentially offering benefits in efficacy and tolerability. In a
Phase 1 trial, intranasal betahistine demonstrated good tolerance
and significantly higher plasma concentrations in comparison with
oral betahistine. In Meniere's disease, the objective of treatment
with AM-125 is the treatment or prevention of vertigo attacks. In
the case of vertigo, the objective is to restore balance.
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
Meniere's disease and vestibular 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 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, including the likelihood that the
TACTT3 clinical trial with Keyzilen® will not meet its endpoints,
the acceptability of the data from AMPACT1 and AMPACT2 in support
of a potential new drug application to the FDA and other
regulators, 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; the use of proceeds from Auris Medical's
recent equity offering and the ability of Auris Medical to finance
its operations in the future. 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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