Sound Pharmaceuticals (SPI) presents Phase 2b STOP ototoxicity data selected for podium presentation at the Association for Otolaryngology Research (ARO) Midwinter Meeting (February 3-7) in Anaheim, California To do.
In this first safety and efficacy study of SPI-1005 (ebselen) for the prevention and treatment of aminoglycoside-induced ototoxicity, patients receiving intravenous (IV) administration of tobramycin for the treatment of acute pulmonary exacerbations Sixty adult CF patients were enrolled. Ototoxicity (hearing loss, tinnitus, dizziness or vertigo) is a common side effect of aminoglycoside antibiotics (tobramycin, amikacin, gentamicin and streptomycin). Currently, there are no FDA-approved treatments for the prevention/treatment of aminoglycoside ototoxicity or for the treatment of other types of sensorineural hearing loss, tinnitus, or vertigo.
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In a Phase 1b observational study (N=20), SPI demonstrated that a 14-day course of intravenous tobramycin resulted in ototoxicity rates of 89% and 93% at 2 and 4 weeks after completion of aminoglycoside therapy. (Harruff, Journal of Cystic Fibrosis, 2021). In a phase 2b intervention study, adult patients were randomized in a double-blind manner to three different doses of ebselen or a placebo, administered orally for 21 days within 3 days of starting intravenous tobramycin. In the phase 2b study (N=40), ototoxicity rates were 73% and 63% at 2 and 4 weeks after completion of aminoglycoside treatment, a statistically significant reduction compared to the phase 1b study ( p-value <0.05)). No significant differences in age, duration of intravenous tobramycin, concomitant medications, respiratory status, or baseline hearing loss were observed between studies.
Interim analysis of Phase 2b results showed that ototoxicity rates decreased dose-proportionately (placebo, 200, 400, and 600 mg ebselen), with ototoxicity rates of 44% and 4 weeks for the 400 and 600 mg doses. It was shown that 43%. (400 mg, p-value <0.05).
“To our knowledge, these are the first positive results of an ototoxic intervention trial in humans receiving antibiotic treatment for lung exacerbations,” said SPI Co-Founder and Chief Executive Officer. says Jonathan Kill, MD.
Results from two other preclinical studies on the treatment of Ebselen, a novel anti-inflammatory compound that has also shown positive results in clinical trials including acute noise exposure, bipolar mania, and Meniere’s disease, will be presented at ARO It is.
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