SEATTLE, Sept. 25, 2018 /PRNewswire/ -- Sound Pharmaceuticals (SPI) is pleased to announce that its recent submission to the upcoming North American Cystic Fibrosis Conference (NACFC) Oct. 18-20 has been selected as a late-breaking abstract. This presentation will focus on the incidence and severity of ototoxicity in CF patients undergoing intravenous (IV) tobramycin treatment for acute pulmonary exacerbation. Ototoxicity (hearing loss, tinnitus, vertigo or dizziness) is a common side effect of tobramycin and other aminoglycoside antibiotics (amikacin, gentamycin and streptomycin). Currently, there are no FDA approved therapies for the prevention or treatment of ototoxicity or any other type of sensorineural hearing loss, tinnitus, or dizziness.
Previous reports of tobramycin induced ototoxicity vary widely in the CF population and have relied heavily on single center retrospective analyses. Additional reasons for this variance include a lack of consistent patient selection, dosing, audiometric methods, and applied ototoxic criteria. SPI-3005-501 is a randomized double-blind placebo-controlled multi-center Phase 1/2 clinical trial involving ebselen (SPI-1005) to prevent and treat tobramycin induced ototoxicity. "To our knowledge, this is the first prospective detailed study of ototoxicity in a CF population undergoing a standard treatment for pulmonary exacerbation across multiple US sites," said Jonathan Kil, MD, SPI's Co-Founder, CEO and Chief Medical Officer. Additional data will be presented involving the pharmacokinetics of tobramycin levels during SPI-1005 treatment.
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 are pleased to have completed this initial work and its selection as a late-breaking paper," said Dr. Flume.
Support for this clinical trial is also provided by the Cystic Fibrosis Foundation through a $1.8M award to SPI. Details of this trial (NCT02819856) can be viewed online at www.clinicaltrials.gov, or by visiting www.soundpharma.com.
SOURCE Sound Pharmaceuticals