Home / Pipeline
Programs across hearing loss and balance disorders
Each program pairs a drug with a local formulation matched to its delivery needs. Our lead program, SPT-2101, is in development for Ménière's disease.
Next milestone: SPT-2101 US IND clearance, 2027
SPT-2101Ménière's diseaseDexamethasone otic suspension
2027 US IND clearance
The product
SPT-2101 is an investigational dexamethasone otic suspension that forms a crosslinked hydrogel at the round window membrane. It is placed under direct visualization with MICS™ (Minimally Invasive Cochlear System), by intratympanic administration in the clinic under local anesthesia.
Clinical data
70%of patients had complete resolution of definitive vertigo days at three months after a single administration, the study's primary endpoint. Phase 1b/2a, four sites in Australia, with no serious adverse events.
View trial registration (ANZCTR)What's next
US IND clearance in 2027, followed by a registrational trial with a design informed by our analysis of prior Ménière's programs. Sudden hearing loss follows as a second indication in Europe.
