Sound Pharmaceuticals (SPI)—a Seattle, Wash-based start-up company developing therapies for hearing loss—announced that it has completed enrollment on its first Meniere’s Disease (MD) clinical trial. MD is a neurotologic disease that involves episodic vertigo, fluctuating sensorineural hearing loss, and intermittent or constant tinnitus, and is thought to be due to a swelling or inflammation of the inner ear. Patients with MD may also complain of aural fullness or pressure, and in extreme cases, may require surgery to decompress the inner ear. SPI-1005, an investigational new drug that mimics and induces Glutathione Peroxidase (GPx), has been shown to reduce the swelling or edema of the inner ear in animal studies involving acoustic trauma, according to Sound.

The American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS) says that 600,000 people in the United States have MD.

“We are thrilled to have completed enrollment on this groundbreaking study involving Meniere’s disease,” said Sujana Chandrasekhar, past-president of the AAO-HNS and a study investigator.

In this Phase 1b study, repeat assessments of hearing loss, tinnitus, and vertigo were used to determine the safety, tolerability, and efficacy of SPI-1005 versus placebo before and after treatment. SPI-1005 was dosed orally twice daily for 21 days and has demonstrated excellent safety and tolerability to date, according to Sound.

“We look forward to presenting these positive findings involving SPI-1005 at the Triological Society Meeting later this year,” said Jonathan Kil, MD, president and CEO.

In an earlier Phase 2 clinical trial, SPI-1005 was shown to prevent sensorineural hearing loss in young adults exposed to noise. These AAO-HNS-presented findings have now been accepted for publication by a prestigious medical journal, according to Sound. Taken together, these results suggest a broad potential for SPI-1005 in the treatment of several types of sensorineural diseases of the inner ear. Currently, there are no FDA-approved drug treatments for MD, or any other neurotologic disease. According to the CDC, sensorineural hearing loss is the third largest chronic disease. Tinnitus, the abnormal perception of sound, affects 10-15% of adults according to the AAO-HNS.

Details of the SPI-1005 clinical trial can be viewed online here, or by visiting the Sound Pharmaceuticals website here.

Source: Sound Pharmaceuticals