Phase 2 Trial Testing SPI-1005 for Ototoxicity in CF Patients Moving Forward
Sound Pharmaceuticals (SPI) has enrolled its first-patient-in — meaning the first subject meeting the criteria for inclusion and exclusion of a clinical study — in a Phase 2 trial testing SPI-1005 for the prevention and treatment of tobramycin-induced ototoxicity in cystic fibrosis (CF) patients, the company announced.
Tobramycin is an intravenous (into-the-vein) antibiotic treatment prescribed for CF-related pulmonary exacerbations (acute worsening of lung problems) and lung infections caused by bacteria. However, the treatment can cause ototoxicity, which is a complication that results in hearing loss, tinnitus, vertigo, or dizziness.
To date, the U.S. Food and Drug Administration has not approved a therapy for the prevention or treatment of ototoxicity. SPI currently has four active investigational new drug applications related to inner ear and neurotology (neurological disorders of the ear).
The encapsulated ebselen medication SPI-1005 is being tested for the prevention and treatment of ototoxicity in a randomized, double-blind, placebo-controlled, multicenter Phase 1/2 trial, known as the STOP Ototoxicity study (NCT02819856), which began last year to assess the efficiency and safety of the treatment.
CF patients receiving intravenous tobramycin (10 mg/kg/day) with active pulmonary exacerbation will be treated with 200, 400, or 600 mg SPI-1005 for 21 days. Assessments at the beginning and end of the study will look at the severity of lung function, sensorineural hearing loss, tinnitus, and vertigo.
The recently completed Phase 1b trial, which is part of the same study, reported an 80-100% ototoxicity prevalence in CF patients receiving intravenous tobramycin. The condition appeared one month after completing one round of the treatment.
About 50% of the participants in the study experienced moderate to moderate-severe hearing loss at the beginning of the study or at the start of tobramycin treatment.
“The significant hearing loss documented in this young adult population (average age was 27) was twice of what we expected,” Jonathan Kil, MD, SPI’s CEO and chief medical officer, said in a press release.
The study is being led by Patrick Flume, MD, professor of medicine and pediatrics at the Medical University of South Carolina in Charleston. Flume is a CF and pulmonary disease expert, and has served as co-chair in 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,” Flume said.