The CFFT development award—given to companies working on treatments for cystic fibrosis—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 is ototoxicity, or damage to the inner ear. 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, according to Sound Pharmaceuticals.
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 sites nationwide. 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 Flume.
Ototoxicity is 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.
Hearing Review has published several articles related to ototoxicity and the development of drugs used to treat this side effect.
Source: Sound Pharmaceuticals, Hearing Review
