Frequency Therapeutics tanks as hearing loss trial fails

Shares of US regenerative medicines firm Frequency Therapeutics (Nasdaq: FREQ) plummeted more than 80% to $0.75 yesterday, after it announced it is terminating programs in sensorineural hearing loss (SNHL) because FX-322 failed to meet the goal of a study in people with acquired SNHL, and is slashing its workforce.

The placebo-controlled Phase IIb study of FX-322 in individuals with acquired SNHL, 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.