An injection of the steroid dexamethasone in a gel formulation into the ear has dramatically reduced the number of days Meniere’s disease patients have vertigo in an early clinical trial.
Three months after receiving the breakthrough treatment, 70% of patients were no longer having definitive vertigo days (DVDs) – defined as any day with a vertigo attack lasting 20 minutes or longer.
SPT-2101 is a sustained-release steroid formulation for the treatment of Meniere’s and is the lead program of US-based hearing therapeutics start up, Spiral Therapeutics.
Lead investigator, Dr Jafri Kuthubutheen, a Perth ENT, otology and skull base surgeon, was the first in the world to perform the novel surgical procedure and use the technology on 10 patients in his tertiary care neurotology clinic.
Results of the small phase 1 study were published online on 1 June 2024 in Otology & Neurotology.
Hearing Practitioner Australia has since learned that the trial is being extended nationwide and if successful will extend internationally next year to phase III trials.
After receiving the novel long-acting dexamethasone formulation delivered precisely to the ear’s round window membrane, vertigo control was measured with DVDs.
The average number of DVDs was 7.6 during the baseline month decreasing to 3.3 by month one, 3.7 by month two, and 1.9 by month three. Seventy percent of patients had zero DVDs during the third month after treatment.
“SPT-2101 delivery to the round window is safe and feasible, and controlled trials are warranted to formally assess efficacy,” the researchers concluded.
The prospective, unblinded, cohort study aimed to investigate the safety and feasibility of precise delivery of a long-acting gel formulation containing 6% dexamethasone (SPT-2101) to the round window membrane for the treatment of Menière’s disease.
Ten adults aged 18 to 85 years with a diagnosis of unilateral definite Menière’s disease per Barany Society criteria received a single injection of the formulation under direct visualisation into the round window niche.
Main outcome measures were the procedure success rate, adverse events, and vertigo control. Precise placement of the drug at the round window was achieved in all 10 patients with unilateral Menière’s disease with in-office microendoscopy.
Adverse events included one tympanic membrane perforation, which healed spontaneously after the study, and two instances of otitis media, which resolved with antibiotics. Patients in the trial are followed up for six months.
Trial now extending nationwide
The facilities involved in this next stage of the trial will be Linear Clinical Research and South Perth Hospital, WA, where Dr Kuthubutheen works, Flinders Medical Centre, SA, The Royal Victorian Eye and Ear Hospital, Melbourne, and Sydney Adventist Hospital, Wahroonga.
Landmark publication and significant milestone
Spiral Therapeutics said the trial showed significant improvement in the frequency of patient reported vertigo episodes and other efficacy outcome measures and provided hope for millions suffering from balance disorders and hearing loss.
“This landmark publication represents a significant milestone in our journey to combat inner ear disorders. Our lead candidate, SPT-2101, showcases promising outcomes in the treatment of Ménière’s disease through our novel MICS drug delivery platform, designed for precise targeting and sustained release,” it said.
MICS gives continuous drug diffusion across the membrane and into the cochlea for one to three months after a single precise injection under direct vision.
Sprial Therapeutics said the MICS (minimally-invasive cochlear system) delivery platform delivered drugs to the ear with high precision and long duration. The formulations achieve “weeks to months of residence in the middle ear, and can be adapted to deliver drugs with anti-inflammatory, otoprotective and neuroprotective activity for the treatment of balance disorders and hearing loss.”
Dr Kuthubutheen thanked the Spiral team for its incredible support.
“This is indeed an important milestone in our journey to find better ways to treat Meniere’s disease that affects so many of our patients,” he said. “I’m looking forward to what the future holds as we reimagine the way we treat inner ear disease.”
Spiral Therapeutics thanked Dr Kuthubutheen for “his pioneering spirit and expertise which had been invaluable in this journey” along with other researchers from Spiral Therapeutics and the Department of Otorhinolaryngology-Head & Neck Surgery, UCSF, America.
Dr Kuthubutheen is a Clinical Professor in the Division of Surgery, Medical School, University of Western Australia, and works at several hospitals including Fiona Stanley Hospital, Perth Children’s Hospital and Sir Charles Gairdner Hospital.
Ear Science Institute Australia says about 40,000 Australians are affected by Meniere’s disease, a debilitating disorder of the inner ear that causes vertigo, tinnitus, dizziness, nausea, hearing loss and balance problems.
Dexamethasone is a glucocorticoid medication used to treat rheumatic problems, skin diseases, asthma, COPD, croup, brain swelling, severe allergies and eye pain after eye surgery.
For more details see the Australian New Zealand Clinical Trials Registry.
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