Sound Pharmaceuticals

Sound Pharmaceuticals is one of the companies working on medications to prevent and/or treat hearing loss. Here's the story of their progress:

July 2004 - Here's the latest on the pill to prevent hearing loss!

June 2006 - Drug to Prevent and Treat NIHL Enters Clinical Testing

January 2007 - Sound Pharmaceuticals Completes Successful Clinical Trial

July 2008 - Sound Pharmaceuticals Receives Additional DoD Funding

August 2008 - Sound Pharmaceuticals Files Second IND with the FDA

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Anti-NIHL Drug Submitted to FDA

July, 2004

Editor: Here's the latest on the "hearing pill" from Sound Pharmaceuticals. This is the pill that is supposed to prevent noise induced hearing loss (NIHL) if the pill is taken BEFORE (or possibly right after) exposure to loud noise.

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Sound Pharmaceuticals submits the first Investigational New Drug Application to the FDA involving an Oral Compound to Prevent Noise Induced Hearing Loss.

June 30th, 2004

SEATTLE, WA--Sound Pharmaceuticals, Inc. (SPI) has submitted its first Investigational New Drug Application (IND) to the Food and Drug Administration to begin human clinical trials on its first otoprotectant drug. SPI-1005 is an oral compound that will be tested to reduce the hearing loss associated with noise exposure.

The first population will involve 60 active military personnel in a phase I/II study at Madigan Army Medical Center at Fort Lewis, in Tacoma, Washington. The United States military has a long history with noise induced hearing loss evaluation and provides an ideal setting for the clinical testing of otoprotective drugs.

"This is a significant milestone in the evolution of our research and development and our company," stated CEO & President, Jonathan Kil, MD. "To our knowledge, this marks the first time that a drug compound for noise induced hearing loss has entered the FDA regulatory process, such as an IND application." Ultimately, SPI-1005 and its derivatives could be tested for the prevention and treatment of tinnitus and age-related hearing loss, two conditions that are a result of acute and chronic noise exposure. Currently, there are no approved medications for the prevention and treatment of noise induced hearing loss, tinnitus or age-related hearing loss.

According to the NIH, CDC and NIOSH, hearing loss is the most common neurosensory disorder and the most common occupational disease. Hearing loss is found in all age groups and can seriously compromise the quality of life or job performance of those affected.

Sound Pharmaceuticals, Inc. is a drug development company focused on treating hearing loss. To date, Sound Pharmaceuticals' drug discovery program has identified targets for the prevention of hearing loss and for the improvement of hearing in individuals with hearing loss. For more information please visit http://www.soundpharmaceuticals.com

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Sound Pharmaceuticals Completes Successful Clinical Trial

January 2007

Editor: We've been following a the development of a couple of products intended to prevent and/or treat noise induced hearing loss for several years. Here's some good news about one of those products!

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Sound Pharmaceuticals (SPI) has completed Phase I clinical testing of SPI-1005, an oral compound, under development for the prevention and treatment of noise induced hearing loss. Results from this 32 patient study and the protocol of an upcoming Phase II clinical study in 80 noise-exposed volunteers will be presented at the 30th Association for Research in Otolaryngology Midwinter Meeting in Denver, CO on Feb. 10-15. SPI has established a Cooperative Research Development Agreement with the Naval Medical Research Center to conduct this Phase II study at Camp Pendleton, CA.

"We are very pleased with the outcome of our first clinical study," said Bret MacPherson, VP and Director of Clinical Operations. "This marks a major milestone for SPI as it transitioned its first product pipeline into clinical development." SPI is developing three product pipelines for indications in noise induced, chemotherapy induced and age-related hearing loss. In addition, SPI intends to apply these drug candidates to other neurodegenerative diseases including traumatic brain injury.

According to two recent studies conducted by Clarity and The Ear Foundation in 2004 and 2006, half of the nearly 76 million Baby Boomers in the U.S. are experiencing some degree of hearing loss. These findings suggest that hearing loss has become the leading chronic disease or disorder in adults aged 41-60. Currently there are no FDA approved drugs for the prevention and treatment of hearing loss. SPI hopes to address this unmet medical need with its first-in-class first-in-indication drug.