If successful, SPI-1005 could become the first approved oral pharmacological treatment specifically targeting the underlying disease processes involved in Meniere’s disease. Image: BZXO/stock.adobe.com. Sound Pharmaceuticals has completed enrolment in its second phase 3 open-label clinical trial of SPI-1005, an investigational oral therapy for Meniere’s disease, bringing the drug a step closer to potential...
No actionable change at this time; enrolment completion is a milestone announcement and no efficacy or safety results have been reported yet.
Meniere's disease has very limited disease-modifying treatment options, so a completed Phase 3 trial of an oral drug targeting its underlying mechanism is a significant pipeline milestone for the audiology and ENT field.
- 01Sound Pharmaceuticals has completed enrolment for a Phase 3 trial of SPI-1005 for Meniere's disease.
- 02SPI-1005 is an investigational oral drug designed to target underlying disease processes, not just symptoms.
- 03Phase 3 is the final large-scale human testing stage before regulatory approval can be sought.
- 04No efficacy or safety results have been released; this is a process milestone only.
- 05Meniere's disease causes episodes of vertigo, fluctuating hearing loss, and tinnitus with few current disease-modifying options.
SPI-1005 targets the underlying disease processes of Meniere's disease.
press releaseunclear- Publication type
- research_article
- Evidence level
- 1b
- Population
- Adults with Meniere's disease
- Intervention
- SPI-1005 (investigational oral drug)
Primary outcomes
Disease modification in Meniere's disease