Sound Pharmaceuticals’ IND Involving Cochlear Implantation Allowed by the FDA
May 20 2024 - 10:18AM
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 6th 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
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PR & Corporate Communications Ms. Silke Artner & Ms.
Nicola Trussell Tel.: +43 577880 press@medel.com
www.medel.com/press-room