Sound Pharmaceuticals (SPI) announced 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 the Medical University of South Carolina (MUSC) in Charleston. According to the release, Dr Flume is an 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 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” according to SPI. Hearing loss, tinnitus, vertigo, and/or dizziness are commonly experienced following aminoglycoside treatment, but are often underreported. 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 nonprofit drug discovery and development affiliate of the Cystic Fibrosis Foundation, through a $1.8 million grant to SPI.