Sound Pharmaceuticals initiates STOP Ototoxicity Study in Cystic Fibrosis

Sound Pharmaceuticals (SPI) is pleased to announce that it has initiated enrollment on its first study involving Cystic Fibrosis (CF) patients receiving antibiotics that cause inner ear disease or ototoxicity. The STOP Ototoxicity study is led by Patrick Flume, MD, Professor of Medicine and Pediatrics at MUSC in Charleston. Dr. Flume is an international expert in CF and pulmonary disease and has co-chaired the development of the CF Foundation's care guidelines on the treatment of pulmonary exacerbations. "We recently explored the incidence of tinnitus and vertigo in the CF population, and will present these initial findings at the next North American CF Conference," said Dr. Flume.

CF patients are vulnerable to ototoxicity because they receive repeated courses of tobramycin or amikacin (aminoglycosides), through inhaled and injected routes of administration, starting at a very young age. A serious and common side effect of aminoglycoside antibiotic treatments involves damage to several sensorineural structures within the inner ear, and is defined medically as ototoxicity. Hearing loss, tinnitus, vertigo and/or dizziness are commonly experienced following aminoglycoside treatment, but are often under reported due to the poor implementation of specific diagnostic protocols or neurotologic assessments. Another factor is the absence of an interventional strategy that would prevent or treat the ototoxicity. SPI has designed and is now implementing a novel approach to documenting and ultimately treating aminoglycoside induced ototoxicity. "We are pleased to have achieved this significant developmental milestone in the CF population," said Jonathan Kil, MD, SPI's Co-Founder, CEO and Chief Medical Officer. Support for this clinical trial is also provided by the Cystic Fibrosis Foundation Therapeutics Inc. (CFFT), the non-profit drug discovery and development affiliate of the Cystic Fibrosis Foundation through a $1.8M grant to SPI.

Ototoxicity is a common side effect in many medical treatments involving chemotherapy, antibiotics and loop diuretics. The combination of these drugs can be contraindicated, especially in conditions where kidney function is already impaired. These highly ototoxic medications can cause progressive inner ear damage and disability. In some cases, the ototoxicity becomes dose-limiting while patients are being actively treated. Currently, there are no FDA approved drugs for the prevention or treatment of any type of sensorineural hearing loss or tinnitus including ototoxicity. Details of this trial (NCT02819856) can be viewed online at www.clinicaltrials.gov, or by visiting www.soundpharma.com.