Positive Clinical Data for Otonomy's OTO-104 in Debilitating Ear Disorder
Novel Treatment is Well-Tolerated and Demonstrates Improvement in Debilitating Symptoms of Severe Inner Ear Disorder
San Diego, CA, April 28, 2011 -- Otonomy, Inc., a clinical stage biopharmaceutical company developing innovative therapeutics for diseases and disorders of the inner and middle ear, today announced positive data from a Phase 1b study of the company’s lead product candidate, OTO-104, in patients with Ménière’s disease. Study results showed OTO-104 to be well-tolerated at both doses tested when delivered via a single intratympanic (IT) injection. Additionally, while not powered to demonstrate statistically significant clinical activity, data from the trial showed that patients receiving OTO-104 experienced greater reductions in vertigo frequency and tinnitus compared to patients receiving placebo. Otonomy plans to discuss these study findings with the United States Food and Drug Administration (FDA) and initiate a Phase 2 clinical trial of OTO-104 in Ménière’s disease by the end of 2011.
“OTO-104 was well-tolerated at both doses and we experienced no technical issues with administration of the sustained release formulation via IT injection,” stated Paul R. Lambert, M.D., professor and chair of the department of otolaryngology – head and neck surgery, Medical University of South Carolina, and the study’s lead investigator. “Furthermore, the improvements in vertigo and tinnitus observed in this study support the potential benefit of OTO-104 in the treatment of patients with Ménière's disease and suggest that further evaluation in this patient population is warranted.”
A total of 44 patients with unilateral
Ménière’s disease were enrolled in this
prospective, randomized, double-blind, placebo-controlled
multicenter study. Patients participated in a one-month baseline
period to characterize disease status, followed by randomization to
receive a single IT injection of OTO-104 (3mg or 12mg) or placebo.
Patients were monitored over a three-month observation period
following injection. The study’s primary objective was the
evaluation of the safety and tolerability of OTO-104 when
administered via a single IT injection. Additionally, the study
evaluated various indicators of OTO-104 clinical activity including
changes in vertigo, tinnitus, hearing function and patient quality
of life.
“We are excited by the results from our first clinical trial
since they validate the potential of our novel sustained release
therapeutic approach and bolster our plan to develop a portfolio of
products to treat a broad range of inner and middle ear
disorders,” said David A. Weber, Ph.D., president and chief
executive officer of Otonomy. “We look forward to discussing
these encouraging clinical results with the FDA and advancing
towards our goal of delivering an approved drug treatment option
for patients suffering from the debilitating symptoms of
Ménière’s disease.”
About OTO-104
OTO-104 is a sustained release formulation of the steroid dexamethasone that has been designed for intratympanic (IT) injection into the middle ear for the potential treatment of a broad range of inner ear disorders including vertigo, hearing loss and tinnitus. OTO-104 is based on Otonomy’s proprietary formulation technology which is intended to overcome the limitations associated with the use of unapproved short acting solutions in the ear. These include limited drug exposure, large variability of delivered dose and the need for multiple IT injections.
About Ménière's Disease
Ménière's disease is a disorder of the inner ear characterized by acute episodes of vertigo, fluctuations in hearing, tinnitus and aural fullness. The underlying cause of Ménière's disease is unknown and there are currently no FDA-approved drug treatments. According to the National Institute on Deafness and Other Communication Disorders (NIDCD), approximately 615,000 individuals have been diagnosed with Ménière's disease in the United States.
About Otonomy
Otonomy is a clinical stage biopharmaceutical company developing innovative therapeutics for diseases and disorders of the inner and middle ear. There are currently no FDA-approved drug treatments for the nearly 30 million Americans that are affected by debilitating hearing and balance diseases and disorders such as Ménière's disease, sudden sensorineural hearing loss, noise-induced hearing loss, age-related hearing impairment and tinnitus. Otonomy’s core technology is a sustained release formulation developed for optimal delivery of drugs to the middle and inner ear with a single intratympanic (IT) injection. This technology has broad applicability across a range of therapeutic classes and two products based on this platform are in active development.
Otonomy's lead product candidate, OTO-104, is a sustained release
formulation of the steroid dexamethasone. A Phase 1b clinical trial
in Ménière’s disease patients has recently been
completed, and future studies are being planned in
Ménière’s disease and other inner ear
disorders. OTO-201, the company’s second product candidate,
is a novel sustained release antibiotic being developed for the
treatment of chronic otitis media. OTO-201 clinical trials are
expected to begin in 2011. Additional product candidates are
expected to target acute and chronic forms of hearing loss, balance
disorders, and tinnitus.
For more information visit:
www.otonomy.com
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Posted: April 2011
