Improving Lives By Protecting Hearing

Ménière’s disease is a chronic condition characterized by acute vertigo attacks, tinnitus, fluctuating hearing loss and a feeling of aural fullness. Of these symptoms, the vertigo attacks are typically most troubling for patients since they disrupt daily activities and are difficult to anticipate and manage. In general, patients are diagnosed with unilateral Ménière’s disease in middle age and symptoms often continue for decades. Over time, the fluctuating hearing loss becomes permanent in many patients, and a subset of patients will develop symptoms in their second ear. According to the National Institute of Deafness and Other Communication Disorders, there are more than 600,000 patients diagnosed with Ménière’s disease in the United States. There is no known cure for Ménière’s disease and there are currently no FDA-approved drug treatments.

Our lead program, SPT-2101 (6% dexamethasone formulated for sustained release), recently completed a Phase 1b/2a clinical trial in Ménière’s disease.

 Using Spiral’s proprietary Minimally Invasive Cochlear System (MICS™) platform in the clinic, SPT-2101 was delivered precisely to the round window membrane for extended release in all study participants. 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-2101 demonstrated a dramatic reduction in Definitive Vertigo Days at Month 3 (78.7%). The data suggest higher dexamethasone exposures correlated with improved vertigo management across the treatment period, regardless of baseline disease severity.