SPI-1005 may help prevent ear damage due to antibiotics use in CF

Findings from Phase 2 trial to be shared at medical conference in February

Marisa Wexler, MS avatar

by Marisa Wexler, MS |

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Treatment with SPI-1005 in adults with cystic fibrosis (CF) appeared to lessen the risk of ear damage related to antibiotics use — widely prescribed for treating lung infections in CF patients — in a Phase 2 clinical trial.

That’s according to new interim data from the STOP study (NCT02819856), announced by Sound Pharmaceuticals, the developer of the experimental therapy, an oral form of the drug ebselen.

Specifically, use of SPI-1005 resulted in a “statistically significant reduction” in the rates of ototoxicity — damage to hearing and/or balance after taking medications, such as antibiotics, that affect the inner ear — among CF patients with acute pulmonary exacerbation, or periods of sudden symptom worsening, according to a company press release.

Sound will be sharing the findings in a presentation at the Association for Research in Otolaryngology (ARO) Midwinter Meeting, to be held Feb. 3-7 in Anaheim, California. An otolaryngologist, more commonly known as an ENT, is a specialist who treats conditions affecting the ears, nose, and throat.

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People with cystic fibrosis are at high risk of bacterial lung infections, and when these infections occur, antibiotics are the primary line of treatment. A class of antibiotics called aminoglycosides, which include tobramycin, are often used to combat infections in people with CF.

But while tobramycin and other aminoglycosides can be effective for fending off bacteria, they also carry a high risk for causing ototoxicity, or ear damage, which can lead to symptoms such as hearing loss; vertigo, a sensation of motion or spinning; dizziness; and tinnitus, a persisting ringing in the ears.

To date, there are no treatments that have been proven to prevent or reverse ototoxicity related to aminoglycoside antibiotics use. Sound is developing SPI-1005 (ebselen) with the goal of filling this need.

To our knowledge, these are the first positive results of an ototoxicity intervention trial in humans undergoing antibiotic treatment for pulmonary exacerbation.

The STOP trial enrolled 40 adults with CF who were undergoing treatment with intravenous — IV or into-the-vein — tobramycin due to an acute pulmonary exacerbation. Within three days of their first use of tobramycin, participants were started on SPI-1005 or a placebo, taken once daily for three weeks.

Three doses of SPI-1005 were tested: 200, 400, and 600 mg.

The interim analyses show that, at one month after starting on IV tobramycin, rates of ototoxicity were highest among patients given the placebo, followed by those given 200 mg SPI-1005, and then the two higher doses. The rates of ototoxicity in the 400 and 600 mg dose groups were 44% and 43%, respectively.

To put these rates in perspective, in an earlier observational study that included 20 CF patients treated only with IV tobramycin, the rate of ototoxicity one month after starting on the antibiotic was 93%.

“To our knowledge, these are the first positive results of an ototoxicity intervention trial in humans undergoing antibiotic treatment for pulmonary exacerbation,” said Jonathan Kil, MD, Sound’s co-founder and CEO.

The company noted that “no significant differences in age, duration of IV tobramycin, concomitant medications, respiratory status, or baseline [at the trial’s start] hearing loss were observed between the studies.”

The STOP clinical trial is supported in part by a grant from the Cystic Fibrosis Foundation.