We are passionate about coupling our deep understanding of the neuroscience of the ear with our drug delivery and development expertise to advance a broad product pipeline to address significant unmet needs in neurotology.
OTO-313 is a sustained-exposure formulation of gacyclidine, a potent and selective NMDA receptor antagonist, in development for the treatment of tinnitus. In July 2020, we announced positive top-line results from a Phase 1/2 clinical trial of OTO-313 in patients with persistent tinnitus of at least moderate severity. We are currently conducting a Phase 2 clinical trial for OTO-313, with top-line results expected in mid-2022. We are also evaluating the safety of higher and bilateral dosing of OTO-313.
OTO-413 is a sustained-exposure formulation of brain-derived neurotrophic factor (BDNF) in development for the treatment of hearing loss. In December 2020, we announced positive top-line results from a Phase 1/2 clinical trial of OTO-413, demonstrating that a single intratympanic injection of OTO-413 was well-tolerated and showed therapeutic activity across multiple speech-in-noise hearing tests. We are currently conducting a Phase 2a clinical trial for OTO-413, with top-line results expected early in the second quarter of 2022. We are also clinically evaluating higher dosing of OTO-413.
OTO-825 is a gene therapy targeting mutations in the gap junction beta 2 gene (GJB2), which is the most common cause of congenital hearing loss. Based on preclinical studies including positive results in two proof-of-concept hearing loss models presented at the ASGCT Annual Meeting in May 2021, we have selected OTO-825 as a candidate for clinical development. Together with our corporate collaborator, Applied Genetic Technologies Corporation (AGTC), we have completed a Pre-IND meeting with the FDA, initiated IND-enabling activities, and expect to file an IND for this program in the first half of 2023.
OTO-510 is a product candidate in preclinical development for the prevention of hearing loss due to chemotherapy with cisplatin (CIHL). This novel molecule has demonstrated improved otoprotection in preclinical studies compared to other agents in development, and is being formulated to provide sustained exposure from a single intratympanic injection. The goal of the OTO-510 program is to preserve hearing without protecting the tumor.
The OTO-6XX program is focused on cochlear hair cell repair or regeneration for the treatment of severe hearing loss.
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