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FREQ : New Results Suggest Hearing Of Individuals Administered With FX-322 May Improve

Frequency Therapeutics Inc. (FREQ) said that new results from its FX-322-111 open-label study suggested that the hearing of individuals administered with a single dose of FX-322 may improve over extended periods.FX-322 is Frequency's lead product candidate for the treatment of acquired sensorineural hearing loss or SNHL, which is the primary cause of more than 90 percent of all cases of hearing loss.

FX-322 is designed to regenerate auditory sensory hair cells located in the cochlea within the inner ear and to potentially restore hearing in individuals with SNHL.

The company noted that the longer-term measures of their treated ear demonstrated word recognition score improvements when compared to pre-treatment baseline levels and no significant changes were detected in their untreated ears.

Of the five subjects that had a statistically significant response at day-90, the four that returned for evaluation had scores that remained above their baseline word recognition measures, though were below the threshold for statistical significance.

The company stated that the four additional sensorineural hearing loss subjects from its FX-322-111 open-label study achieved statistically significant hearing improvements when evaluated 8 to 12 months following initial dosing.

Including the five initial responders, there are now a total of nine subjects that participated in the FX-322-111 study (n=32) that have been shown to have statistically significant improvements in word recognition scores, a key measure of speech perception, at time points between 90 days and one year.

The FX-322-111 study is an open-label, multi-center, single-dose trial designed to evaluate the impact of FX-322 injection conditions on tolerability, as well as key measures of hearing benefit. In the study, subjects with mild to severe SNHL (n=33) were injected in one ear with FX-322, with the untreated ear serving as the control.

Hearing function was tested in 32 subjects --one subject did not finish the study-- over the course of 90 days following dosing. Twenty-five subjects were subsequently evaluated at 8-12 months following FX-322 dosing, with four subjects that had shown improvement trends in word recognition scores at day-90 reaching statistically significant scores when tested at the later time points.

The company plans to initiate a new FX-322 Phase 2 trial in the fourth quarter of this year to evaluate the impact of single-dose FX-322 administration in a refined population of individuals with SNHL.

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