Auris Medical Receives FDA Guidance at Type C Meeting for AM-111 in the Treatment of Sudden Sensorineural Hearing Loss
August 30 2018 - 8:16AM
Zug, Switzerland, August 30, 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 disorders supportive care,
announced today feedback from a Type C meeting with the U.S. Food
and Drug Administration (FDA) related to the development plan and
regulatory pathway for AM-111, its investigational treatment for
sudden sensorineural hearing loss.
The Type C meeting had been requested by the
Company following the results of the HEALOS phase 3 trial. The
results showed, based on a post-hoc analysis, a clinically
meaningful and nominally significant improvement in hearing for the
AM-111 0.4 mg/mL group compared to placebo in the subpopulation of
patients with acute profound hearing loss. These patients were
initially completely deaf or almost deaf on the affected ear and
normally would have faced a particularly poor prognosis for hearing
recovery.
The FDA reviewed the Company's proposed concept
for a placebo-controlled pivotal trial with AM-111 0.4 mg/mL in
patients suffering from acute profound hearing loss. The trial
protocol builds to a large extent on the design and outcomes from
HEALOS and also incorporates specific feedback provided by the
European Medicines Agency (EMA) earlier this year. In a written
response the FDA endorsed the proposed choice of primary and
secondary efficacy endpoints, the safety endpoints, as well as the
planned sample size and statistical methodology. In addition, the
FDA provided important guidance on the regulatory path forward.
"We very much appreciate the FDA's feedback and
guidance for our AM-111 program", commented Thomas Meyer, Auris
Medical's founder, chairman and CEO. "We are very pleased to be
aligned with the FDA and EMA on key design aspects for the planned
phase 3 trial and look forward to working with the agencies as we
continue to develop AM-111 as a potential first-in-class treatment
for sudden sensorineural hearing loss." As previously announced,
the Company intends to move the AM-111 development program forward
through partnering.
About Sudden Sensorineural Hearing
Loss
Acute injury to the cochlea, e.g., from
overexposure to noise, bacterial or viral infections, inflammation
or vascular compromise may result in damage to inner ear hair cells
and neurons and acute hearing loss. Thanks to cellular defenses and
intrinsic repair mechanisms, a certain amount of hearing loss can
be recovered in the subsequent days and weeks following the insult.
However, the remaining hearing loss is irreversible. Sudden
sensorineural hearing loss may be accompanied by other disorders of
the inner ear such as dizziness or tinnitus, and if it develops
into permanent hearing loss, it may have chronically debilitating
consequences. Hearing loss may have a serious impact on
professional and personal lives, e.g. through avoidance or
withdrawal from social situations, reduced alertness and increased
risk to personal safety, impaired memory and ability to learn new
tasks, or reduced job performance and earning power. To date, there
exists no treatment with proven efficacy for acute inner ear
hearing loss.
About AM-111
AM-111 is being developed in a biocompatible gel
formulation for the treatment of sudden sensorineural hearing loss
with a single-dose administration into the middle ear. Its active
substance is brimapitide (also known as D-JNKI-1, D-stereoisomer of
c-Jun N-terminal Kinase Inhibitor 1), a cell-penetrating peptide
which inhibits the JNK stress kinase. JNK is activated following
various types of cochlear insults (stress) that cause acute inner
ear hearing loss and plays a key role in apoptosis of sensory cells
as well as in inflammatory responses. By blocking JNK, AM-111
protects stress-injured cochlear cells and helps to prevent or
reduce chronic hearing loss. AM-111's otoprotective effects have
been demonstrated in various animal models of cochlear stress,
including acute acoustic trauma, acute labyrinthitis
(inflammation), drug ototoxicity (aminoglycosides), bacterial
infection, cochlear ischemia and cochlear implantation trauma.
AM-111 has orphan drug designation from both the US Food and Drug
Administration and the European Medicines Agency, and it was
granted Fast Track status by the FDA.
About Auris Medical
Auris Medical is a Swiss biopharmaceutical
company dedicated to developing therapeutics that address important
unmet medical needs in neurotology and mental disorders 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: AM-111 for
sudden sensorineural 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."
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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,
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Company contact: Hernan Levett, Chief Financial Officer, +41 61
201 1350
investors@aurismedical.com
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