FDA Approves Sound Pharmaceuticals' IND for Cochlear Implantation

SEATTLE & INNSBRUCK, Austria--Sound Pharmaceuticals (SPI) has received FDA approval to proceed with its Investigational New Drug Application (IND) for SPI-1005 treatment in conjunction with cochlear implantation (CI). The Phase 2 trial aims to mitigate the loss of residual hearing during and after CI. SPI-1005, known as ebselen, is an innovative anti-inflammatory compound that mimics and induces Glutathione Peroxidase activity, an enzyme critical for hearing and balance. Ebselen has demonstrated safety and efficacy in treating various forms of acquired sensorineural hearing loss in adults, including acute noise-induced hearing loss, Meniere’s disease, and antibiotic-induced ototoxicity.

The Phase 2 trial will enroll 40 adult candidates scheduled for cochlear implants. These candidates must have residual low-frequency hearing that is moderately to severely impaired and at risk of further loss post-CI. Participants will be randomized to receive either SPI-1005 or a placebo for six months, beginning two days before the CI procedure. They will be monitored for an additional six months post-treatment to evaluate if SPI-1005 can prevent or treat residual hearing loss compared to the placebo.

This trial marks the sixth IND involving SPI-1005, which has been tested in 13 studies with over 850 participants. Currently, SPI-1005 is undergoing a pivotal Phase 3 trial for active Meniere’s disease, targeting symptoms such as hearing loss, tinnitus, vertigo, and dizziness. The drug has received Fast Track designation by the FDA for these indications.

In this endeavor, SPI is partnering with MED-EL, a prominent medical device company with a 40-year history of advancing cochlear implantation, especially in hearing preservation. The two companies have an exclusive global collaboration agreement for the use of SPI-1005 with cochlear implants. Over the past two years, MED-EL has provided upfront, research and development, and equity support.

At present, there are no FDA-approved therapies for sensorineural hearing loss, tinnitus, vertigo, or dizziness. SPI-1005 is the sole investigational new drug candidate in active Phase 3 trials addressing these conditions. The trials are available for viewing online.

About Sound Pharmaceuticals (SPI)
Sound Pharmaceuticals is a leading biotechnology company focused on developing the first drug treatment for hearing loss and tinnitus. These conditions, along with vertigo and dizziness, affect over 50 million Americans and constitute the largest neurologic disabilities in the industrialized world. SPI, a private company headquartered in Seattle, WA, is managed by co-founder and CEO Jonathan Kil, MD. Dr. Kil has spearheaded SPI's R&D since its inception and has been the Principal Investigator on multiple grants from the Department of Defense, National Institutes of Health, and the Cystic Fibrosis Foundation.

About MED-EL
MED-EL Medical Electronics is a pioneering company in implantable hearing solutions, committed to eliminating hearing loss as a barrier to communication and quality of life. Founded by Ingeborg and Erwin Hochmair, whose groundbreaking research led to the development of the world's first micro-electronic multi-channel cochlear implant in 1977, MED-EL has grown significantly since its official establishment in 1990. Currently, the company employs over 2,700 people from around 80 nations, operating in 30 locations worldwide.

MED-EL offers a comprehensive range of implantable and non-implantable hearing solutions to treat various types of hearing loss. Its products are used by people in 136 countries, enabling them to experience the gift of hearing. MED-EL’s hearing solutions include cochlear and middle ear implant systems, a combined electric acoustic stimulation hearing implant, auditory brainstem implants, and both surgical and non-surgical bone conduction devices.

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