Sound Pharmaceuticals (SPI) will present data on the incidence and severity of ototoxicity in cystic fibrosis (CF) patients who received tobramycin for the treatment of acute pulmonary exacerbations.
The presentation, which was accepted as a late-breaking abstract, will be given at the upcoming North American Cystic Fibrosis Conference (NACFC), taking place Oct. 18-20 in Denver.
Ototoxicity — a complication that can result in hearing loss, tinnitus (perception of noise or ringing in the ears), vertigo (sensation of spinning while stationary), or dizziness — is known to be a common side effect of treatment with tobramycin and similar antibiotics, such as amikacin, gentamicin, and streptomycin.
Prior reports of tobramycin-related ototoxicity in CF patients vary widely, and have been based on data from single-center retrospective studies. Furthermore, a lack of standardized patient selection, dosing, audiometric methods, and ototoxic criteria also contributes to inconsistent data.
At this time, the U.S. Food and Drug Administration has not approved any therapeutic to help prevent or treat ototoxicity or any other type of hearing loss, tinnitus, or dizziness.
SPI researchers therefore launched a randomized, double-blind, placebo-controlled, multicenter Phase 1/2 clinical trial (NCT02819856) to evaluate the ability of 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 U.S. sites,” Jonathan Kil, MD, SPI’s co-founder, CEO, and chief medical officer, said in a press release.
The primary objective of the trial is to assess the safety and tolerability of SPI-1005 in CF patients who have active pulmonary exacerbations and are receiving an intravenous (directly into the blood) course of tobramycin.
Secondary objectives are to determine the pharmacokinetics (the movement of a drug throughout the body) of oral SPI-1005 at 200, 400, and 600 mg for 21 days.
The study, known as the STOP Ototoxicity 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 world-renowned leader in the field of CF and pulmonary disease, and has served as a co-chair in the development of the Cystic Fibrosis 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,” he said.
This clinical trial is being supported by the Cystic Fibrosis Foundation through a grant given to SPI.