Results expected in second half of 2020
SAN DIEGO, CA, USA I September 17, 2019 I Otonomy, Inc. (NASDAQ: OTIC), a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology, today announced the initiation of a Phase 1/2 clinical trial of OTO-413, a sustained-exposure formulation of brain-derived neurotrophic factor (BDNF), in patients with hearing loss. The Phase 1/2 trial is a randomized, double-blind, placebo-controlled, single ascending dose study designed to evaluate the safety and exploratory efficacy of OTO-413 in patients with speech-in-noise hearing difficulty.
“Recent scientific research in the neurotology field has demonstrated that damage or loss of synaptic connections between inner ear hair cells and spiral ganglion neurons, known as cochlear synaptopathy, is involved in the hearing difficulty that many people experience in a loud environment, and that this pathology may also play a role in age-related and noise-induced hearing loss,” said Andrea Vambutas, M.D., Director for the Center of Hearing & Balance at the New York Head & Neck Institute. “Repair of the synaptic connection through local administration of a neurotrophic factor such as BDNF holds promise for patients with speech-in-noise hearing difficulty, and this Phase 1/2 clinical trial provides an exciting first opportunity to evaluate this therapeutic approach.”
“Initiating this clinical trial as planned keeps us on track to have results for three clinical programs in 2020 – the OTIVIDEX™ Phase 3 trial in Ménière’s disease in the first half of 2020, the OTO-313 Phase 1/2 trial in tinnitus patients in the first half of 2020, and this OTO-413 Phase 1/2 trial in the second half of 2020,” said David A. Weber, Ph.D., president and CEO of Otonomy. “Furthermore, advancing this program into clinical development also highlights our leadership in neurotology with clinical-stage programs addressing hearing loss, tinnitus, and balance disorders, the largest indications and market opportunities in this emerging field.”
About OTO-413
OTO-413 is a proprietary, sustained-exposure formulation of brain-derived neurotrophic factor (BDNF), which is a naturally occurring protein involved in neuron growth and repair. Nonclinical studies have demonstrated that local administration of BDNF repairs ribbon synapses damaged due to noise trauma or exposure to ototoxic chemicals, and restores hearing function. The initial indication for OTO-413 is speech-in-noise hearing difficulty, a type of hearing loss believed to be caused by cochlear synaptopathy that affects an estimated 9 million people in the United States. A Phase 1/2 clinical trial evaluating the safety and exploratory efficacy of OTO-413 in patients with speech-in-noise hearing difficulty is expected to have results in the second half of 2020.
About Otonomy
Otonomy is a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology. The company pioneered the application of drug delivery technology to the ear in order to develop products that achieve sustained drug exposure from a single local administration. This approach is covered by a broad patent estate and is being utilized to develop a pipeline of products addressing important unmet medical needs including Ménière’s disease, hearing loss, and tinnitus. For additional information please visit www.otonomy.com.
SOURCE: Otonomy
Post Views: 120
Results expected in second half of 2020
SAN DIEGO, CA, USA I September 17, 2019 I Otonomy, Inc. (NASDAQ: OTIC), a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology, today announced the initiation of a Phase 1/2 clinical trial of OTO-413, a sustained-exposure formulation of brain-derived neurotrophic factor (BDNF), in patients with hearing loss. The Phase 1/2 trial is a randomized, double-blind, placebo-controlled, single ascending dose study designed to evaluate the safety and exploratory efficacy of OTO-413 in patients with speech-in-noise hearing difficulty.
“Recent scientific research in the neurotology field has demonstrated that damage or loss of synaptic connections between inner ear hair cells and spiral ganglion neurons, known as cochlear synaptopathy, is involved in the hearing difficulty that many people experience in a loud environment, and that this pathology may also play a role in age-related and noise-induced hearing loss,” said Andrea Vambutas, M.D., Director for the Center of Hearing & Balance at the New York Head & Neck Institute. “Repair of the synaptic connection through local administration of a neurotrophic factor such as BDNF holds promise for patients with speech-in-noise hearing difficulty, and this Phase 1/2 clinical trial provides an exciting first opportunity to evaluate this therapeutic approach.”
“Initiating this clinical trial as planned keeps us on track to have results for three clinical programs in 2020 – the OTIVIDEX™ Phase 3 trial in Ménière’s disease in the first half of 2020, the OTO-313 Phase 1/2 trial in tinnitus patients in the first half of 2020, and this OTO-413 Phase 1/2 trial in the second half of 2020,” said David A. Weber, Ph.D., president and CEO of Otonomy. “Furthermore, advancing this program into clinical development also highlights our leadership in neurotology with clinical-stage programs addressing hearing loss, tinnitus, and balance disorders, the largest indications and market opportunities in this emerging field.”
About OTO-413
OTO-413 is a proprietary, sustained-exposure formulation of brain-derived neurotrophic factor (BDNF), which is a naturally occurring protein involved in neuron growth and repair. Nonclinical studies have demonstrated that local administration of BDNF repairs ribbon synapses damaged due to noise trauma or exposure to ototoxic chemicals, and restores hearing function. The initial indication for OTO-413 is speech-in-noise hearing difficulty, a type of hearing loss believed to be caused by cochlear synaptopathy that affects an estimated 9 million people in the United States. A Phase 1/2 clinical trial evaluating the safety and exploratory efficacy of OTO-413 in patients with speech-in-noise hearing difficulty is expected to have results in the second half of 2020.
About Otonomy
Otonomy is a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology. The company pioneered the application of drug delivery technology to the ear in order to develop products that achieve sustained drug exposure from a single local administration. This approach is covered by a broad patent estate and is being utilized to develop a pipeline of products addressing important unmet medical needs including Ménière’s disease, hearing loss, and tinnitus. For additional information please visit www.otonomy.com.
SOURCE: Otonomy
Post Views: 120
