>> LEXINGTON, Mass.--(BUSINESS WIRE)--Feb. 13, 2023-- Frequency Therapeutics, Inc. (Nasdaq: FREQ), a regenerative medicine company focused on developing therapeutics to activate a person’s innate potential to restore function, today announced clinical results from the placebo-controlled Phase 2b study of FX-322 in individuals with acquired Sensorineural Hearing Loss (SNHL).
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.
Why do they do "improvement in speech perception"? I can certainly see that this is the most important quality of life improvement, but did they first do any more basic testing such as hearing sensitivities across frequency? I ask because sometimes I'm not interested in hearing people better than I am in hearing music better. :-)
I think the study measured improvements in tonal frequency precerception as a preliminary measurement. The final measurement was for speech perception. They did not release the study, as this is just preliminary announcement. This must be a big let down for the company. It looks like they are pivoting away from hearing to an MS treatment.
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.
This is disappointing.