An effective treatment for Ménière’s disease appears a step closer after a world first initial clinical trial in Australia of a gel steroid injection reported ‘significant reductions in vertigo frequency and severity’, an otolaryngology conference has heard.
US-based hearing therapeutics start up, Spiral Therapeutics, announced the successful completion of the phase 1b/2a clinical trial which tested safety, side effects and best dose of the new treatment SPT-2101 (6% dexamethasone).
The long-acting steroid is injected during surgery in a crosslinking gel formulation into the round window membrane of the ear. The platform ensures targeted, sustained drug release over two months directly to the cochlea.
Results were presented at the American Academy of Otolaryngology Annual Meeting 2024 in Miami on 28 September 2024.
“Data review of 21 patients showed a significant reduction in vertigo frequency and severity,” Perth surgeon Dr Jafri Kuthubutheen said. “The study recruited 21 patients across sites in Perth, Melbourne and Sydney.”
Dr Kuthubutheen was the first in the world to perform the novel surgical procedure and led the Australian study.
The trial included two cohorts. Cohort one received a single administration of SPT-2101 (6% dexamethasone) to 10 patients. Cohort two involved a 1:1 randomisation with six patients receiving a single administration of SPT-2101 (50 μL of 6% dexamethasone) and five receiving a control (saline intratympanic injection), with an optional crossover opportunity for non-responders (three patients crossed over).
“Using Spiral’s proprietary Minimally Invasive Cochlear System platform in the clinic, dexamethasone was delivered precisely to the round window membrane for extended release in all study participants,” Dr Kuthubutheen said.
“No serious adverse events (SAEs) or unexpected adverse events (AEs) were reported, and no negative impact on hearing was observed. All patients experienced full resolution of the myringotomy.
“The treatment with SPT-2101 showed superior vertigo management compared to the control group, with a statistically significant difference (p< 0.05).
“Additionally, non-responders in the placebo group who crossed over to receive SPT-210 demonstrated a dramatic reduction in definitive vertigo days (DVDs) at month three (78.7%).”
DVDs are defined as any day with a vertigo attack lasting 20 minutes or longer.
Dr Kuthubutheen said the data suggested higher dexamethasone exposures correlated with improved vertigo management across the treatment period, regardless of baseline disease severity.
Exciting for patients
Dr Habib Rizk, director of the vestibular program at the Medical University of South Carolina and president of the board of directors of the Vestibular Disorders Association said: “These preliminary results for SPT-2101 are exciting for Ménière’s disease patients debilitated by their vertigo episodes.
“Reliable delivery of steroids into the inner ear may be the key to having patients achieve remission. I am looking forward to seeing Spiral Therapeutics progress with phase three studies to confirm these promising findings.”
Chief medical officer of Spiral Therapeutics, Dr Charles Limb, also chief of the Division of Otology, Neurotology, and Skull Base Surgery at University of California San Francisco, Spiral Therapeutics CEO Mr Hugo Peris and senior vice-president Mr Jeff Sharon presented the preliminary results at the meeting.
“The encouraging outcomes from this trial reflect Spiral’s innovative approach, which combines the concurrent development of a novel therapeutic medication together with a unique delivery procedure using the world’s smallest microendoscope for clinical use in the ear,” Dr Limb.
“We look forward to continuing our clinical trials so that we can finally offer an effective treatment for Meniere’s disease.”
Peris added: “We are excited to share these positive early results that not only demonstrate the efficacy of SPT-2101 but also reinforce the value of the platform, which ensures and extends drug exposure to the inner ear.
“These positive results mark a significant milestone in our mission to address the unmet needs of patients with Meniere’s disease. The ability to deliver precise, sustained doses of medication directly to the inner ear while remaining minimally invasive is a critical advance for the field.”
Further analyses are ongoing and more results will be reported in coming weeks, he said.
Peris claimed the clinical results of SPT-2101 surpassed those of Otonomy’s OTO-104 (6% dexamethasone in a thermoreversible gel formulation) administered with a standard intratympanic injection which consistently showed a small efficacy signal on the management of severe vertigo in this patient population.
Spiral acquired data on OTO-104 and a right of reference from Otonomy in 2023. Across all measured endpoints, SPT-2101 demonstrated superior outcomes, validating Spiral’s approach, he added.
