SAN DIEGO, CA, USA I December 1, 2014 I Otonomy, Inc. (OTIC), a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapeutics for diseases and disorders of the inner and middle ear, today announced that the company has achieved target enrollment in its Phase 2b clinical trial of OTO-104 in patients with Meniere’s disease.
This prospective, randomized, double-blind, placebo-controlled study is designed to assess the efficacy and safety of OTO-104 for the treatment of Meniere’s disease in a total of 140 patients. In the Phase 2b clinical trial, patients are observed for up to four months following a single intratympanic (IT) injection of either OTO-104 or placebo. The primary endpoint, consistent with the previous Phase 1b clinical trial, is the reduction in vertigo frequency during Month 3 following treatment compared to a one month baseline period. The clinical trial has been designed and is being conducted to serve as one of two pivotal, single-dose efficacy trials that the company expects the FDA will require to support a New Drug Application (NDA) filing for treatment of Meniere’s disease.
“We would like to thank the patients for their participation, and the clinical investigators for their support in achieving our enrollment goal for this trial,” said David A. Weber, Ph.D., president and CEO of Otonomy. “A number of potential subjects are still completing the one month lead-in period of the trial, which could result in total enrollment that will exceed 140. We continue to expect results in the second quarter of 2015.”
About OTO-104
OTO-104, which has been granted Fast Track designation by the FDA, is a sustained-exposure formulation of the steroid dexamethasone in development for the treatment of Meniere’s disease and other inner ear conditions. Otonomy has completed a randomized, prospective, double-blind, placebo-controlled, Phase 1b clinical trial of a single IT injection of OTO-104 in patients with Meniere’s disease. Results demonstrated that OTO-104 is well tolerated when administered as a single IT injection, and 12 mg of OTO-104 was associated with clinically meaningful improvements in both vertigo frequency and tinnitus compared to placebo three months after treatment. There were no serious adverse events observed during the clinical trial. A Phase 2b single-dose efficacy trial with approximately 140 Meniere’s disease patients is ongoing in the U.S. and Canada, with results expected in the second quarter of 2015. The company believes this trial will serve as one of two pivotal, single-dose efficacy trials required to support U.S. regulatory approval. OTO-104 is also being evaluated in a multiple-dose safety study in the United Kingdom in patients with Meniere’s disease, and the company expects the results of which will support regulatory filings in this indication.
About Meniere’s Disease
Meniere’s disease is a chronic condition characterized by acute vertigo attacks, tinnitus, fluctuating hearing loss and a feeling of aural fullness. Of these symptoms, the vertigo attacks are typically most troubling for patients since they disrupt daily activities and are difficult to anticipate and manage. In general, patients are diagnosed with unilateral Meniere’s disease in middle age and symptoms often continue for decades. Over time, the fluctuating hearing loss becomes permanent in many patients, and a subset of patients will develop symptoms in their second ear. According to the National Institute of Deafness and Other Communication Disorders, there are more than 600,000 patients diagnosed with Meniere’s disease in the United States. There is no known cure for Meniere’s disease and there are currently no FDA-approved drug treatments.
About Otonomy
Otonomy is a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapeutics for diseases and disorders of the ear. Otonomy’s proprietary technology provides sustained exposure of drugs to the middle and inner ear following a single intratympanic (IT) injection. Otonomy has three product candidates in development. AuriPro(TM) is an antibiotic that has completed Phase 3 clinical trials in pediatric patients with middle ear effusion at the time of tympanostomy tube placement surgery. OTO-104 is a steroid that is in the first of two pivotal clinical studies for the treatment of patients with Meniere’s disease. OTO-311 is an NMDA receptor antagonist in development as a treatment for tinnitus. For additional information, please visit www.otonomy.com.
SOURCE: Otonomy
Post Views: 62
SAN DIEGO, CA, USA I December 1, 2014 I Otonomy, Inc. (OTIC), a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapeutics for diseases and disorders of the inner and middle ear, today announced that the company has achieved target enrollment in its Phase 2b clinical trial of OTO-104 in patients with Meniere’s disease.
This prospective, randomized, double-blind, placebo-controlled study is designed to assess the efficacy and safety of OTO-104 for the treatment of Meniere’s disease in a total of 140 patients. In the Phase 2b clinical trial, patients are observed for up to four months following a single intratympanic (IT) injection of either OTO-104 or placebo. The primary endpoint, consistent with the previous Phase 1b clinical trial, is the reduction in vertigo frequency during Month 3 following treatment compared to a one month baseline period. The clinical trial has been designed and is being conducted to serve as one of two pivotal, single-dose efficacy trials that the company expects the FDA will require to support a New Drug Application (NDA) filing for treatment of Meniere’s disease.
“We would like to thank the patients for their participation, and the clinical investigators for their support in achieving our enrollment goal for this trial,” said David A. Weber, Ph.D., president and CEO of Otonomy. “A number of potential subjects are still completing the one month lead-in period of the trial, which could result in total enrollment that will exceed 140. We continue to expect results in the second quarter of 2015.”
About OTO-104
OTO-104, which has been granted Fast Track designation by the FDA, is a sustained-exposure formulation of the steroid dexamethasone in development for the treatment of Meniere’s disease and other inner ear conditions. Otonomy has completed a randomized, prospective, double-blind, placebo-controlled, Phase 1b clinical trial of a single IT injection of OTO-104 in patients with Meniere’s disease. Results demonstrated that OTO-104 is well tolerated when administered as a single IT injection, and 12 mg of OTO-104 was associated with clinically meaningful improvements in both vertigo frequency and tinnitus compared to placebo three months after treatment. There were no serious adverse events observed during the clinical trial. A Phase 2b single-dose efficacy trial with approximately 140 Meniere’s disease patients is ongoing in the U.S. and Canada, with results expected in the second quarter of 2015. The company believes this trial will serve as one of two pivotal, single-dose efficacy trials required to support U.S. regulatory approval. OTO-104 is also being evaluated in a multiple-dose safety study in the United Kingdom in patients with Meniere’s disease, and the company expects the results of which will support regulatory filings in this indication.
About Meniere’s Disease
Meniere’s disease is a chronic condition characterized by acute vertigo attacks, tinnitus, fluctuating hearing loss and a feeling of aural fullness. Of these symptoms, the vertigo attacks are typically most troubling for patients since they disrupt daily activities and are difficult to anticipate and manage. In general, patients are diagnosed with unilateral Meniere’s disease in middle age and symptoms often continue for decades. Over time, the fluctuating hearing loss becomes permanent in many patients, and a subset of patients will develop symptoms in their second ear. According to the National Institute of Deafness and Other Communication Disorders, there are more than 600,000 patients diagnosed with Meniere’s disease in the United States. There is no known cure for Meniere’s disease and there are currently no FDA-approved drug treatments.
About Otonomy
Otonomy is a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapeutics for diseases and disorders of the ear. Otonomy’s proprietary technology provides sustained exposure of drugs to the middle and inner ear following a single intratympanic (IT) injection. Otonomy has three product candidates in development. AuriPro(TM) is an antibiotic that has completed Phase 3 clinical trials in pediatric patients with middle ear effusion at the time of tympanostomy tube placement surgery. OTO-104 is a steroid that is in the first of two pivotal clinical studies for the treatment of patients with Meniere’s disease. OTO-311 is an NMDA receptor antagonist in development as a treatment for tinnitus. For additional information, please visit www.otonomy.com.
SOURCE: Otonomy
Post Views: 62
