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Frequency Therapeutics Announces Topline Results for its Phase 2b Study of FX-322 for the Treatment of Sensorineural Hearing Loss
FX-322-208 Study Fails to Meet Primary Endpoint, Showing No Significant Separation in Speech Perception Between FX-322 and Placebo Company Will Now Focus on
About this update from Korro Bio, Inc.
[{"type":"text","content":"\nFX-322-208 Study Fails to Meet Primary Endpoint, Showing No Significant Separation in Speech Perception Between FX-322 and Placebo\n\nCompany Will Now Focus on Advancing its Program in Remyelination for Multiple Sclerosis (MS)\n\nAnnounces Corporate Restructuring and Will Also Explore Strategic Financing Alternatives; Net of Debt, has Cash and Marketable Securities of $68.9mm as of December 31, 2022\n\n LEXINGTON, Mass.--(BUSINESS WIRE)--\nFrequency 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).\n\nThe 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.\n\nThe 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 1b 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.\n\n“This was a rigorous and well-designed study that provided us a clear outcome, though not the outcome we wanted. Given these disappointing results, we will cease further development of the Company's drug candidates for hearing loss. We are thankful to the patients, clinicians and their staffs, and the experts from our clinical advisory board who helped us to d...