Sound Pharmaceuticals (SPI) is pleased to announce positive topline results from its recently completed Phase 1b SPI-1005-151 clinical trial involving Meniere’s Disease (MD). SPI-1005 is an investigational new drug that mimics and induces glutathione peroxidase activity, and has demonstrated strong proof-of-concept in preventing sensorineural hearing loss. MD is diagnosed by episodic vertigo, fluctuating hearing loss, and intermittent or constant tinnitus, and is thought to be due to a swelling or inflammation of the inner ear. Currently, there are no FDA approved drug treatments for MD, or any other inner ear disease. Many with MD are managed with low salt diets, thiazide diuretics, and oral or locally injected steroids, although these treatments have not proven to be effective.
In this randomized double blind placebo controlled Phase 1b study, 40 MD volunteers (average age 53 years old) were enrolled at three different US sites. SPI-1005 or matching placebo was taken orally for 21 days, and repeat assessments of hearing and balance were conducted over an 8 week period. 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. “We have submitted these ground breaking data for presentation to the Association for Research in Otolaryngology meeting,” said Jonathan Kil, MD, Co-Founder, CEO and CMO.
In the randomized double blind placebo controlled Phase 2b SPI-1005-251 clinical trial, 120 MD volunteers will have repeat assessments of their hearing loss, tinnitus and vertigo, to determine the safety and efficacy of SPI-1005 versus placebo, before and after 28 days of treatment. “We are excited to have initiated enrollment of this second study involving Meniere’s disease,” said Dr. Sujana Chandrasekhar, a leading neurotologist, past president of the American Academy of Otolaryngology-HNS, and study investigator. In an earlier Phase 2 clinical trial, SPI-1005 was shown to prevent the temporary threshold shift due to acute noise exposure or noise induced hearing loss in young adults (average age 20 years old). These data were published July 14, 2017 online in The Lancet, a leading medical journal. The results from these early and mid-stage clinical trials support a broad potential for SPI-1005 in the treatment of several types of inner ear diseases.