In the Phase 1b observational study (N=20), SPI reported that a 14-day course of IV tobramycin resulted in ototoxicity rates of 89% and 93%, at 2 and 4-weeks after aminoglycoside treatment was completed (Harruff, Journal of Cystic Fibrosis, 2021). In the Phase 2b interventional study, adult patients were randomized in a double blinded fashion to 3 different doses of ebselen or placebo, taken orally for 21 days within 3 days of starting IV tobramycin. In the Phase 2b study (N=40), the ototoxicity rates were 73% and 63%, at 2 and 4-weeks after aminoglycoside treatment was completed, a statistically significant reduction when compared to the Phase 1b study (p-value 2b results shows a dose proportional decrease in the ototoxicity rate (from placebo, 200, 400, to 600 mg ebselen), with the 400 and 600 mg dose having ototoxicity rates of 44% and 43% at 4-weeks (400 mg, p-value Jonathan Kil, MD, SPI's Co-Founder and CEO. Results from two other preclinical studies involving ebselen treatment, a novel anti-inflammatory compound that has also shown positive results in clinical trials involving acute noise exposure, bipolar mania, and Meniere's disease, will be presented at the ARO.
The CFF provided a $2.2M Therapeutic Development Award to SPI to support the studies. Details of this trial (NCT02819856) can be viewed online at www.clinicaltrials.gov , or by visiting www.soundpharma.com.