ANALYTICAL METHOD DEVELOPMENT, VALIDATION AND STABILITY STUDY OF ORC-13661

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Aminoglycoside antibiotics (AGs) are a class of broad-spectrum antibiotics used to treat serious aerobic, gram-negative infections, in addition to mycobacterial diseases. Ototoxicity due to the death of inner ear hair cells is a common, irreversible adverse effect, limiting the use of AGs. The ototoxic effects of AGs are not limited to hearing loss, but also affect the vestibular system, causing dizziness and impairments to balance. In many patients the balance problems are as apparent and debilitating as hearing deficits. Preclinical data suggests that ORC-13661 (a small molecule) protects hair cells from the cytotoxic effects of AGs by inhibiting the entry of AGs into the hair cell through the mechanoelectrical transduction (MET) channel. The aim of this project is to develop ORC-13661 as an adjunctive therapy to protect inner ear auditory hair cells from the irreversible toxic side effects of AG treatment.