An American biotechnology company will trial giving its new investigational drug to cochlear implant recipients to see if it reduces loss of residual hearing during and after cochlear implantation (CI).
Sound Pharmaceuticals (SPI) is a private company focused on developing the first drug treatment for hearing loss and tinnitus.
It announced on 22 May 2024 that it had received FDA (Food and Drug Administration) notification that its Investigational New Drug Application (IND) may proceed involving SPI-1005 treatment (ebselen) and cochlear implantation.
Sound Pharmaceuticals said ebselen was a novel anti-inflammatory compound that mimics and induces the activity of Glutahione Peroxidase, an enzyme 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,” SPI said in a statement.
“The goal of this phase 2 trial is to reduce the loss of residual hearing during and after CI.”
The trial will enrol 40 adult CI candidates scheduled to receive a cochlear implant who have residual low frequency hearing that is moderate to severely impaired and at risk of being lost after implantation.
Participants will be randomised to receive six months of oral drug PI-1005 or placebo treatment starting two days before CI and followed for an additional six months post-treatment to determine if the drug can prevent and/or treat the loss of residual hearing compared to placebo.
Being tested for Meniere’s disease
The company said this would be the sixth IND involving SPI-1005. It had been tested in 13 studies of more than 850 participants. It is currently being tested in a 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. The companies entered an exclusive worldwide collaborative agreement involving the use of SPI-1005 with cochlear implants.
MED-EL has provided upfront research and development and equity support over the past two years.
The statement said there were currently no FDA approved therapies for the treatment of sensorineural hearing loss, tinnitus, vertigo, or dizziness. SPI-1005 was the only investigational new drug candidate in active phase 3 trials for these indications.
SPI is led by co-founder and CEO Dr Jonathan Kil who has led research and development at the company since inception. He has been the principal investigator on multiple grants from the Department of Defence, National Institutes of Health, and the Cystic Fibrosis Foundation.
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