Nowadays people suffering from hearing loss mostly prefer wearing a hearing aid or a cochlear implant in rare cases. Surely, these devices are helping people to communicate, but they do not treat the main cause of hearing loss. Currently, there is a dire need for new treatments that can cure this clinical disorder.
To address hearing loss, Otonomy Inc., a biopharmaceutical organization working for the development advanced therapeutics for neurotology, has announced the commencement of OTO-413’s Phase 1/2 clinical trial in patients.
The drug is sustained-exposure formulation of brain-derived neurotrophic factor (BDNF). Moreover, this Phase 1/2 trial is a randomized, placebo-controlled, double-blinked, single ascending dose study that is designed to determine the safety and exploratory efficacy of OTO-413 in treating hearing loss.
Director for the Center of Hearing & Balance at the New York Head & Neck Institute, M.D, Andrea Vambutas said that, according to the recent scientific research in neurotology, the damage of synaptic connections between cochlear synaptopathy and inner ear hair is one of the reasons behind hearing loss.
He claims that the treatment of synaptic connection through the local administration of a neurotropic factor-like BNDF can treat patients who are suffering from speech-in-house hearing difficulty. This trial is an exciting first opportunity to evaluate this therapeutic approach and this pathology could play a vital role in age-related and noise-related hearing loss.
David A. Weber, Ph.D., President and CEO of Otonomy, said that initiating this trial would help their company to be on track for three clinical programs in 2020- namely the OTIVIDEX™ Phase 3 trial in Meniere’s disease and OTO-313 Phase 1/2 trial in tinnitus patients in the first half of 2020 and the OTO-413 Phase 1/2 trial in second half of 2020.
Moreover, he claims that advancing this program into clinical development would showcase the company’s expertise in neurotology with clinical-stage programs that address tinnitus, hearing loss, and balance disorders.