Sound Pharmaceuticals (SPI) is pleased to announce that first-patient-in has been achieved in the STOP Ototoxicity Phase 2 clinical trial. This novel interventional study with SPI-1005 is aimed to prevent and treat ototoxicity in Cystic Fibrosis (CF) patients undergoing intravenous (IV) tobramycin for the treatment of acute pulmonary exacerbation. Ototoxicity (hearing loss, tinnitus, vertigo or dizziness) is a leading side effect of aminoglycoside antibiotics (tobramycin) commonly used to treat respiratory infections involving gram negative bacteria (Pseudomonas). 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. SPI is pioneering this area of drug development with four active Investigational New Drug Applications involving the inner ear or neurotology.
The STOP Ototoxicity study is led by Patrick Flume, MD, Professor of Medicine and Pediatrics at MUSC in Charleston, South Carolina. 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. “The prevalence of hearing loss and incidence of ototoxicity in this tobramycin receiving CF population underscores the critical need for an effective neurotologic treatments,” said Dr. Flume.
In the recently completed Phase 1b study reported at the North American CF Conference in Denver, CO, 80-100% of the CF patients showed signs of ototoxicity including clinically relevant hearing loss one month after completing one IV course of tobramycin. In addition, approximately 50% of the volunteers had moderate to moderately-severe hearing loss at baseline or the start of IV tobramycin treatment. “The significant hearing loss documented in this young adult population (average age was 27) was twice of what we expected,” said Jonathan Kil, MD, SPI’s CEO and Chief Medical Officer.