Sound Pharmaceuticals, Inc., (SPI) is pleased to announce that it has been awarded up to $1.6M from Cystic Fibrosis Foundation Therapeutics Inc. (CFFT), the non-profit drug discovery and development affiliate of the Cystic Fibrosis Foundation. The CFFT development award will support the initial testing of SPI-1005 in people with CF who are receiving tobramycin for the treatment of acute pulmonary exacerbations or lung infections. A leading side effect of tobramycin involves damage to the inner ear and is called ototoxicity. The Phase 1b STOP Ototoxicity clinical trial will examine the incidence and severity of hearing loss, tinnitus, dizziness or vertigo due to IV tobramycin treatment. SPI-1005 is a novel oral drug that is being developed to reduce the incidence and severity of sensorineural hearing loss and tinnitus in several disease states including ototoxicity, noise and Meniere’s disease.
The STOP Ototoxicity study will be led by Patrick Flume, MD, Professor of Medicine and Pediatrics at MUSC in Charleston, and will enroll a total of 100 subjects at multiple US sites. 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 thrilled to have the support of the CF Foundation and Dr. Flume on this groundbreaking study of tobramycin-induced ototoxicity,” said Jonathan Kil, MD, SPI’s Co-Founder, CEO and Chief Medical Officer. CF patients are extremely vulnerable to ototoxicity because they receive repeated courses of aminoglycosides, such as tobramycin or amikacin, through inhaled and injected routes of administration, starting at a very young age. “This is the first comprehensive US study of ototoxicity in the CF population and we are pleased to be leading it,” said Dr. Flume.
Ototoxicity is a common side effect in medical treatments involving chemotherapy, antibiotics and loop diuretics. The combination of these classes of drugs can be contraindicated, especially in conditions where kidney function is impaired. These highly ototoxic medications can result in permanent, and often progressive inner ear disease. In some cases, the ototoxicity becomes dose-limiting and results in moderate hearing loss that requires a hearing aid, or severe to profound hearing loss that requires a cochlear implant. Currently, there are no FDA approved drugs for the prevention or treatment of any type of sensorineural hearing loss or tinnitus including ototoxicity or Meniere’s disease.