LEXINGTON, Mass.– Frequency Therapeutics, Inc. (Nasdaq: FREQ), a clinical-stage regenerative medicine company focused on developing therapeutics to activate a person’s innate regenerative potential to restore human function, today announced that four additional sensorineural hearing loss (SNHL) 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.
These new results suggest that the hearing of individuals administered with a single dose of FX-322 may improve over extended periods. 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.
“These insights will guide future studies as we consider evaluating individuals over longer periods and add further flexibility to our trial designs, both to maximize the opportunity to observe these improvements, and better understand when increases in intelligibility may start to wane,” said David L. Lucchino, Frequency’s President and Chief Executive Officer. “We also plan to assess individuals treated in our other studies to evaluate if those subjects may have experienced these longer-term benefits.”
FX-322 is Frequency’s lead product candidate for the treatment of acquired 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.
“These FX-322 data provide important learnings in the development of a potential hearing loss therapeutic, while showing meaningful improvements in speech perception,” said Sumit Dhar, Ph.D., Hugh Knowles Professor of Hearing Science and the Associate Provost for Faculty at Northwestern University. “The longer response times from certain study subjects is consistent with what we have seen with device interventions and would be expected given the heterogeneity of the auditory system and differences in etiologies, severities and duration of SNHL.”
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.
Subjects in the study had an array of hearing loss etiologies, including sudden SNHL, noise-induced SNHL and idiopathic SNHL. Additionally, the subjects ranged in severity from mild to severe. The single dose had a favorable safety profile and both injection conditions were well tolerated. Based on the overall learnings from the multiple FX-322 learning studies, 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.
An overview of the FX-322-111 study will be shared in a late-breaking scientific presentation titled, A Second Independent Phase 1b Demonstrates Hearing Improvement with FX-322, at the American Academy of Otolaryngology – Head and Neck Surgery Annual Meeting and OTO experience, on October 4, 2021.
