Otologic Pharmaceutics

Otologic Pharmaceutics, Inc. (OPI), established in 2009, is a clinical-stage biopharmaceutical company headquartered in Oklahoma City, focused on addressing the unmet medical need for pharmacological treatments for hearing loss. The company was co-founded by Dr. Richard D. Kopke and Dr. Robert A. Floyd. Dr. Kopke, an otolaryngologist and neurotologist, developed a keen interest in noise-induced hearing loss during his 22-year career as a U.S. Army physician before becoming the CEO of the Hough Ear Institute. This deep-seated experience in auditory trauma directly informs the company's primary research direction. Dr. Floyd is a scientist at the Oklahoma Medical Research Foundation (OMRF), and his collaboration with Dr. Kopke was instrumental in the company's founding.

The company's business model centers on the development and commercialization of novel therapeutics. Its primary revenue streams are anticipated from licensing agreements, partnerships with larger pharmaceutical firms for late-stage clinical trials and distribution, and the eventual sale of its proprietary drugs. A significant milestone was the April 2014 Series A funding round, which raised $4.1 million to advance its lead product candidate. OPI operates in the global hearing loss market, targeting patient populations for whom no pharmacological treatments are currently available. The company's work originated from technology jointly discovered and developed at the Hough Ear Institute (HEI) and OMRF.

OPI's product pipeline features two main candidates. The lead clinical-stage product is NHPN-1010, an oral drug designed to prevent and treat acute hearing loss. This therapeutic combines two antioxidant compounds, HPN-07 and N-acetylcysteine (NAC), to protect the inner ear from damage caused by loud noise, blast trauma, or ototoxic drugs like cisplatin. NHPN-1010 successfully completed Phase 1 safety trials and was later licensed to Oblato Inc. in February 2020 to advance into Phase 2 trials. However, the license was returned to OPI after Oblato shifted its corporate focus, and OPI is currently seeking a new partner to fund the expensive late-stage trials. The second core program is a preclinical asset, Autigen (OPI-001), which utilizes small interfering RNA (siRNA) technology to regenerate sensory hair cells in the cochlea. This approach aims to restore hearing function for individuals with chronic or age-related hearing loss by targeting the Hes1 gene to induce the trans-differentiation of supporting cells into new, functional hair cells. In a significant validation of this approach, Boehringer Ingelheim entered into a collaboration and licensing agreement with Autigen, an OPI subsidiary, in 2022 to further develop this technology.

Keywords: Otologic Pharmaceutics, hearing loss therapeutics, biopharmaceutical, NHPN-1010, Richard D. Kopke, Robert A. Floyd, Hough Ear Institute, sensorineural hearing loss, tinnitus treatment, cochlear hair cell regeneration, siRNA therapy, otoprotection, noise-induced hearing loss, clinical-stage, Auditus LLC, Oblato Inc., Boehringer Ingelheim, Accele Biopharma, Oklahoma Medical Research Foundation, neurotology, audiology, auditory drug development, HPN-07, N-acetylcysteine, Autigen, OPI-001