Sound Pharma Announces Phase 3 Study Completion of SPI-1005 for the Treatment of Meniere’s Disease
2024年7月31日 - 11:06PM
ビジネスワイヤ(英語)
Sound Pharmaceuticals is pleased to announce that the Phase 3
clinical trial involving SPI-1005, a novel anti-inflammatory, for
the treatment of Meniere’s Disease (STOPMD-3) has been completed.
SPI-1005 is an oral capsule taken twice daily and the only
potential therapeutic to significantly improve hearing loss and
tinnitus in Meniere’s Disease patients that was documented in two
completed Phase 1b and 2b studies that enrolled over 165 patients.
The STOPMD-3 study enrolled eligible patients into a randomized
controlled trial (RCT) for 3-months followed by an open label
extension (OLE) of SPI-1005 for 6 months (OLE 6-mo) and an optional
6 additional months (OLE 12-mo). STOPMD-3 is the longest treatment
trial involving an investigational new drug ever completed for a
hearing loss or tinnitus indication. RCT data unblinding and
presentation of the interim topline results will occur this
quarter.
STOPMD-3 randomization began on August 2, 2022 and the last
patient last visit (OLE 12-mo) was completed on July 25, 2024. 254
patients were screened for eligibility at 11 sites including some
of the leading academic centers in the US. 221 eligible patients
were randomized to either SPI-1005 treatment (400 mg twice daily
for 28 days) or matching placebo treatment and followed for 84
days. 201 patients continued onto SPI-1005 OLE for up to 6-mo and
12-mo. “We are grateful to all the patients that participated in
this pivotal trial of SPI-1005,” said Jonathan Kil, MD, Co-Founder
and CEO. SPI-1005 is the only investigational new drug that was
tested in a Phase 3 trial aimed at improving hearing loss,
tinnitus, and/or dizziness over the last three years.
STOPMD-3 was led by Dr. Paul Lambert, Distinguished University
Professor and Chair Emeritus of the Dept. of Otolaryngology-HNS at
MUSC in Charleston, SC, and the past President of the American
Neurotologic Society. “To our knowledge, this Phase 3 study is the
longest continuous treatment trial to improve hearing loss/tinnitus
in patients living with Meniere’s Disease,” said Dr. Lambert. Dr.
Lambert, Dr. Shaun Nguyen, and their colleagues from MUSC also led
the successful Phase 2b RCT involving SPI-1005 and MD patients.
About Meniere’s Disease (MD)
MD is diagnosed by brief periods of episodic vertigo or
dizziness, fluctuating low frequency hearing loss, and intermittent
or constant tinnitus, and is thought to be due to a swelling of the
inner ear. Patients are typically diagnosed between 40-65 years of
age, and the auditory symptoms of hearing loss and tinnitus often
involve only one ear. Some patients experience aural fullness or
pressure in the affected ear that can also contribute to dizziness.
As patients age, the hearing loss and tinnitus become worse
resulting in severe to profound hearing loss or intractable
tinnitus. For the definitive diagnosis of MD, the American Academy
of Otolaryngology-Head & Neck Surgery guidance requires
audiometric documentation of ≥30 dB of low frequency hearing loss
in at least one ear using pure tone audiometry (PTA). Loss of
speech discrimination, especially in noisy environments or when
tinnitus is present, is common in MD and other forms of
sensorineural hearing loss. MD is currently managed with low salt
diets, thiazide diuretics, and oral or locally injected steroids.
Unfortunately, this standard of care has not been proven to be
effective and is not FDA-approved for the treatment of definite or
probable MD.
About SPI-1005
SPI-1005 is an investigational new drug that contains ebselen, a
new chemical entity. Ebselen is a selenorganic compound that mimics
and induces glutathione peroxidase (GPx) activity and is effective
in reducing neuroinflammation across the central and peripheral
nervous system. GPx activity is critical to several cell types and
tissues in the inner ear, retina, prefrontal cortex of brain, lung,
and kidney, and is often reduced during exposures to environmental
insults or aging. Loss of GPx activity has been shown to result in
sensorineural hearing loss in multiple animal models. SPI-1005 is
being developed for several neurotologic indications including
noise-induced hearing loss and two types of ototoxicity (hearing
loss, tinnitus, dizziness, or vertigo) caused by aminoglycoside
antibiotics (such as tobramycin or amikacin) or platinum-based
chemotherapy (such as cisplatin or carboplatin). To date, no
significant drug-drug interactions have been observed across
multiple study populations including bipolar mania and treatment
resistant depression.
About Sound Pharmaceuticals
A privately held biotechnology company is testing SPI-1005 under
five other active Investigational New Drug Applications involving
several neurotologic indications including aminoglycoside-induced
ototoxicity co-funded by the CF Foundation and cochlear implant
patients co-funded by MED-EL. Details of the SPI-1005 clinical
trials can be viewed online at www.clinicaltrials.gov or by
visiting www.soundpharma.com.
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