Topline results for phase IIb study of FX 322 for the treatment of sensorineural hearing loss

The study, which enrolled 142 people with either sudden or noise-induced sensorineural hearing loss, failed to achieve its primary efficacy endpoint of an improvement in speech perception. Data showed no statistically meaningful difference at day 90 between those administered FX 322 versus those receiving placebo in the proportion of individuals that demonstrated an improvement in speech perception. There were also no measurable improvements observed in any of the study’s secondary endpoints. Prior FX 322 studies had been designed to best understand patient etiologies and severities where a hearing signal could be observed. FX-322-208 was statistically powered with a balanced placebo and active group. The safety profile associated with FX 322 was favorable and no study participants experienced a serious adverse event that was associated with treatment.

The Company will now discontinue the FX 322 development program. In addition, while dosing of FX 345, a second program to treat SNHL, has been completed in the initial safety cohort of an ongoing Phase Ib trial, that development program will also be discontinued. The Company will now focus its resources to advance its remyelination in MS program into the clinic.