A Seattle-based privately held biopharmaceutical company, Sound Pharmaceuticals (SPI), said Monday it is advancing Phase 2 hearing loss clinical trial in Cystic Fibrosis, to study SPI-1005 in patients who are receiving intravenous (IV) tobramycin to treat acute pulmonary exacerbation.
According to the data on clinicaltrials.gov, as referred to by the company in its press release, about about 100 patients will be included in this randomized, double-blind, placebo-controlled, dose-escalating, safety, PK, and PD study of oral SPI-1005 in CF patients with active pulmonary exacerbation about to receive a 21-day course of IV tobramycin (10 mg/kg/d). All patients will undergo baseline testing and have their severity of lung function, sensorineural hearing loss, tinnitus and vertigo determined before the start of SPI-1005 treatment. SPI-1005 treatment will start within first two days of IV tobramycin treatment and be administered concomitantly. At the end of the 21-day course of SPI-1005 and 28 days following the cessation of SPI-1005, patients will have their hearing loss, tinnitus and vertigo reassessed. Assessments may also include additional audiometric and pulmonary testing, and additional follow-up testing.
The Estimated Primary Completion Date is July 2019.
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 has four active Investigational New Drug Applications involving the inner ear or neurotology, the company said in its announcement.