Sound Pharmaceuticals’ IND Involving Cochlear Implantation Allowed by the FDA

SEATTLE & INNSBRUCK, Austria--(BUSINESS WIRE)--Sound Pharmaceuticals (SPI) is pleased to announce that it has received FDA notification that its Investigational New Drug Application (IND) may proceed involving SPI-1005 treatment and cochlear implantation (CI). The goal of this Phase 2 SPI-1005 (ebselen) trial is to reduce the loss of residual hearing during and after CI. Ebselen is a novel anti-inflammatory compound that mimics and induces the activity of Glutathione Peroxidase, an enzyme that is critical to hearing and balance. Ebselen has shown safety and efficacy in three different forms of acquired sensorineural hearing loss in adult patients, including loud sound exposure or acute noise induced hearing loss, Meniere’s disease, and antibiotic or aminoglycoside induced ototoxicity.

The Phase 2 trial will enroll 40 adults who are CI candidates and scheduled to receive a cochlear implant. Eligible candidates will have residual low frequency hearing that is moderate to severely impaired and at risk of being lost after CI. The eligible participants will be randomized to receive 6 months of oral drug (SPI-1005 or placebo) treatment starting two days prior to CI and followed for an additional 6 months post-treatment to determine if SPI-1005 can prevent and/or treat the loss of residual hearing when compared to placebo. This marks the 6^th IND involving SPI-1005, which has been tested in 13 studies enrolling over 850 participants to date. SPI-1005 is currently being tested in a pivotal Phase 3 trial involving active Meniere’s disease, where hearing loss, tinnitus, vertigo, and dizziness are common, and has received Fast Track designation by the FDA.

SPI is collaborating with MED-EL, a leading medical device company that has pioneered the field of cochlear implantation over the last 40 years, especially in the area of hearing preservation. SPI and MED-EL entered into an exclusive worldwide collaborative agreement involving the use of SPI-1005 with cochlear implants. MED-EL has provided upfront, R&D, and equity support over the last 2 years.

Currently, there are no FDA approved therapies for the treatment of sensorineural hearing loss, tinnitus, vertigo, or dizziness, and SPI-1005 is the only investigational new drug candidate in active Phase 3 trials for these indications or endpoints. The trials can be viewed online at www.clinicaltrials.gov, or by visiting www.soundpharma.com.

About Sound Pharmaceuticals (SPI)

SPI is the leading biotechnology company focused on developing the first drug treatment for hearing loss and tinnitus. Sensorineural hearing loss, tinnitus, vertigo, and dizziness affect more than 50 million Americans and represent the largest neurologic disabilities throughout the industrialized world. SPI is a private company headquartered in Seattle WA and is led by co-founder and CEO Jonathan Kil, MD. Dr. Kil has led the R&D at SPI since inception and has been the Principal Investigator on multiple grants from the DoD, NIH, and the Cystic Fibrosis Foundation.

About MED-EL

MED-EL Medical Electronics, a leader in implantable hearing solutions, is driven by a mission to overcome hearing loss as a barrier to communication and quality of life. The Austrian-based, privately owned business was co-founded by industry pioneers Ingeborg and Erwin Hochmair, whose ground-breaking research led to the development of the world’s first micro-electronic multi-channel cochlear implant (CI), which was successfully implanted in 1977 and was the basis for what is known as the modern CI today. This laid the foundation for the successful growth of the company in 1990, when they hired their first employees. To date, MED-EL has more than 2,700 employees from around 80 nations and 30 locations worldwide.

The company offers the widest range of implantable and non-implantable solutions to treat all types of hearing loss, enabling people in 136 countries enjoy the gift of hearing with the help of a MED-EL device. MED-EL’s hearing solutions include cochlear and middle ear implant systems, a combined electric acoustic stimulation hearing implant system, auditory brainstem implants as well as surgical and non-surgical bone conduction devices. www.medel.com