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

CONTACT: Dr. Jonathan Kil, President & CEO, Sound Pharmaceuticals, Inc., 4010 Stone Way N Suite 120, Seattle WA 98103, jkil@soundpharmaceuticals.com, 206-634-2559.