Phase 3 Data Offer Hope to Patients With Meniere Disease

Results from a pivotal phase 3 trial of SPI-1005, a novel anti-inflammatory compound, demonstrated that the treatment achieved its coprimary end points for efficacy in patients with Meniere disease, including improvements in hearing loss and speech discrimination.¹

Meniere disease is a disorder of the inner ear that causes vertigo, ringing in the ears, hearing loss, and a feeling of congestion in the ear. Although it typically affects just 1 ear, between 15% and 25% of individuals with the disorder may be affected in both ears. Some patients experience single attacks of dizziness separated by long periods of time, whereas others may have many attacks close together over several days.²

Meniere disease is a disorder of the inner ear | Image credit: BillionPhotos.com | stock.adobe.com

The condition is rare in children and adolescents and is more likely to occur in adults between the ages of 40 and 60 years. Approximately 615,000 individuals in the United States have Meniere disease, and approximately 45,500 cases are newly diagnosed each year.²

There is no cure for Meniere disease, and treatment benefits can be difficult to gauge due to the wide array of symptoms and severity. Limiting salt intake, smoking cessation, medications for dizziness, vestibular rehabilitation, and physical therapy are some common treatments. In addition, injections of gentamicin into the middle ear can help control vertigo but significantly increase the risk of hearing loss as a result of damaged microscopic hair cells in the inner ear. Surgery may also be recommended when no other treatments have been successful to either decompress the endolymphatic sac or cut the vestibular nerve.²

As a result, more effective and safe treatments for Meniere disease are needed for this patient population. SPI-1005 is an oral capsule containing 200 mg ebselen that has shown efficacy and safety in several phase 2 clinical trials for multiple hearing loss and tinnitus indications, including Meniere disease.¹

The phase 3 STOPMD-3 double-blind, placebo-controlled, randomized clinical trial (RCT) enrolled adults (N = 221) with a history of definite Meniere disease and active symptoms. Participants received 28 days of either SPI-1005 (400 mg twice daily) or placebo with monthly follow-up assessments of auditory and vestibular function through 84 days. Compliant patients could immediately enter an open-label extension of SPI-1005 treatment for up to 12 months, during which time patients continued to receive SPI-1005 and had reassessments every 3 months.¹

In both the intent-to-treat and per-protocol RCT analyses, the group that received SPI-1005 showed higher rates of improvement in low frequency hearing loss (≥ 10 dB gain at 1 low frequency from baseline) using pure-tone audiometry (LFPTA) and speech discrimination (≥ 4-word increase from baseline) using the words-in-noise (WIN) test than the placebo group at days 28, 56, and 84 of follow-up. On day 84, the SPI-1005 group showed a significant rate of LFPTA improvement over placebo (57.9% vs 36.5%, an increase of 58.6% over placebo, P = .0037).¹

When LFPTA criteria were increased to require at least a 10 dB gain at 2 adjacent low frequencies from baseline, the SPI-1005 group showed a significant rate of improvement of 204.4% over placebo (41.1% vs 13.5%, P < .0001). On day 84, the SPI-1005 group showed a significant rate of WIN improvement of 54.4% over placebo (42.1% vs 27.1%, P = .0336).¹

The results offer a significant glimmer of hope for individuals with Meniere disease, which is notoriously difficult to treat. Based on these findings, SPI-1005 could be particularly impactful because hearing loss is a major debilitating symptom of Meniere disease, often leading to social isolation and reduced quality of life.

The improvements observed in hearing and speech discrimination with SPI-1005 could translate to a significant improvement in the daily lives of patients with Meniere disease. Better hearing can enhance communication, social interactions, and overall well-being. The potential to reduce the burden of Meniere disease offers hope for a more fulfilling and active life for those affected. Although further research and regulatory approvals are needed, these results represent a promising step forward in the management of Meniere disease and offer renewed hope for patients seeking effective treatment options.

REFERENCES

1. Sound Pharma Announces Positive Phase 3 Results for the Treatment of Meniere’s Disease With SPI-1005. News release. Sound Pharmaceuticals. December 10, 2024. Accessed February 26, 2025. https://soundpharma.com/sound-pharma-announces-positive-phase-3-results-for-the-treatment-of-menieres-disease-with-spi-1005/

2. Meniere’s disease. National Institute on Deafness and Other Communication Disorders. Updated August 15, 2024. Accessed February 26, 2025. https://www.nidcd.nih.gov/health/menieres-disease