Sound Pharma Reports Positive Phase 3 Results for Meniere’s Disease Treatment with SPI-1005

Sound Pharmaceuticals has announced a significant milestone in the treatment of Meniere's Disease with the successful completion of a Phase 3 clinical trial for SPI-1005, a novel anti-inflammatory drug containing ebselen. Meniere's Disease is a challenging inner ear disorder characterized by fluctuating hearing loss, tinnitus, and episodic vertigo or dizziness, with no FDA-approved treatments currently available.

The Phase 3 study, known as STOPMD-3, enrolled 221 adult participants with confirmed active Meniere's Disease symptoms. These individuals were randomly assigned to receive either SPI-1005 or a placebo for 28 days, with follow-up evaluations conducted over an 84-day period. Patients who complied with the trial protocol were allowed to enter an open-label extension (OLE), during which they could receive SPI-1005 for up to a year with regular assessments.

SPI-1005 demonstrated promising results in the study. In both the intent-to-treat and per-protocol analyses, the group receiving the drug showed marked improvements in low-frequency hearing loss and speech discrimination compared to the placebo group. Specifically, by day 84, 57.9% of the SPI-1005 group exhibited significant gains in low-frequency hearing as measured by pure-tone audiometry, a 58.6% improvement over the placebo group. Additionally, improvements in speech discrimination during noisy conditions were observed, with the SPI-1005 group showing a 54.4% increase over placebo.

The open-label extension further supported these findings, with continuous improvements in auditory function, speech discrimination, and patient-reported outcomes for symptoms such as tinnitus, vertigo, and aural fullness. These outcomes highlight SPI-1005's potential to address the debilitating symptoms of Meniere's Disease effectively.

Meniere's Disease often affects individuals aged between 40 to 65 and is characterized by episodic vertigo, fluctuating low-frequency hearing loss, and tinnitus, typically affecting only one ear. The disease may cause severe to profound hearing loss and persistent tinnitus over time. Current management strategies, which include low-salt diets and steroid treatments, have not proven effective nor received FDA approval.

The STOPMD-3 trial, conducted at 11 sites, including major U.S. academic centers, represents the longest continuous treatment study for hearing loss or tinnitus linked to Meniere's Disease. The trial was led by Dr. Paul Lambert and Dr. Shaun Nguyen from the Department of Otolaryngology at the Medical University of South Carolina, building on the success of earlier Phase 2 trials.

SPI-1005, the investigational drug studied in this trial, contains ebselen, a compound that mimics and enhances glutathione peroxidase (GPx) activity. This activity plays a crucial role in protecting various tissues, including those in the inner ear. Loss of GPx activity has been associated with sensorineural hearing loss in animal studies. SPI-1005 is being explored for other neurotologic conditions, including noise-induced hearing loss and ototoxicity caused by certain antibiotics and chemotherapy.

Sound Pharmaceuticals, the biotechnology company behind SPI-1005, continues to investigate this compound under several active Investigational New Drug Applications for various neurotologic indications. This study marks a pivotal step in providing a potential new treatment option for patients suffering from Meniere's Disease, offering hope for improved management of this challenging condition.