SEATTLE, WASHINGTON — Sound Pharmaceuticals, a Seattle-based biotech firm, announced this week that it has achieved positive topline results from its recently completed Phase 1b SPI-1005-151 clinical trial involving Meniere’s Disease (MD) patients. SPI-1005 is the company’s investigational new drug, which mimics and induces Glutathione Peroxidase (GPx), which has been shown to reduce the swelling or edema of the inner ear in animal studies involving acoustic trauma.
Meniere’s Disease affects an estimated 600,000 people in the US, and approximately 5 million worldwide. The condition — with symptoms of vertigo, hearing loss and tinnitus — is often managed, with varying degrees of success, through dietary changes (low salt diet, for example), thiazide diuretics and oral or injected steroids.
Meniere’s Disease Drug Trial
In the randomized, double blind placebo-controlled Phase 1b study, a total of 40 MD volunteers were enrolled at three different US sites. The investigative drug SPI-1005, or matching placebo, was taken orally for 21 days. Assessments of hearing and balance were repeatedly conducted over an 8 week period.
According to the company’s announcement, the SPI-1005 treatment demonstrated “excellent safety, tolerability, and improvements in both auditory and vestibular symptoms that define MD”.
“SPI-1005 treated subjects (55%) showed clinically relevant improvements in low frequency hearing, the frequencies of hearing that are most affected in MD, vs placebo treated subjects (10%) which was significant, p-value <0.05. SPI-1005 treatment also resulted in improvements in word recognition, tinnitus loudness, and vertigo severity versus placebo.”
Sound Pharmaceuticals Co-Founder and CEO, Dr. Jonathan Kil, says the data has been submitted for presentation at the upcoming Association for Research in Otolaryngology meeting.
Positive Results Call for Further Study
In the upcoming Phase 2b SPI-1005-251, randomized, double blind, placebo-controlled clinical trial, a total of 120 MD volunteers will undergo repeated assessments of their hearing, tinnitus and vertigo over the course of 28 days.
“We are excited to have initiated enrollment of this second study involving Meniere’s disease” –Dr. Sujana Chandrasekhar, study investigator
Further details of the SPI-1005 clinical trials can be seen at www.clinicaltrials.gov.
Source: Sound Pharmaceuticals