Business
Frequency Therapeutics Provides Business Updates and Reports First Quarter 2021 Financial Results
Data From Recent FX-322 Clinical Readouts, Including New Data from Phase 1b Study in Presbycusis (Age-Related Hearing Loss), Further Clarify Acquired
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[{"type":"text","content":"\nData From Recent FX-322 Clinical Readouts, Including New Data from Phase 1b Study in Presbycusis (Age-Related Hearing Loss), Further Clarify Acquired Sensorineural Hearing Loss Target Patient Populations and Future Study Design \n\nCompany Anticipates Initiation of New FX-322 Phase 2 Study in H2 2021\n\n LEXINGTON, Mass.--(BUSINESS WIRE)--\nFrequency Therapeutics, Inc. (Nasdaq: FREQ), a clinical-stage biotechnology company focused on harnessing the body’s innate biology to repair or reverse damage caused by a broad range of degenerative diseases, today announced business updates and financial results for the first quarter ended March 31, 2021.\n\n“As we work to develop a novel medicine for the treatment of the most common form of hearing loss, our initial focus has been to investigate the broadest set of potential conditions and severities through a comprehensive series of probing studies. With data from all of our single administration studies, we have been able to better define the groups of patients that we believe are responding to FX-322, while also informing the optimal study design for new placebo-controlled Phase 2 trials,” said David L. Lucchino, Frequency’s Chief Executive Officer.\n\nMost recently, Frequency completed a Phase 1b study (FX-322-112) in subjects with presbycusis (age-related hearing loss). No subjects enrolled in the 112 study had either noise-induced or sudden sensorineural hearing loss (SSNHL), conditions where FX-322 associated hearing benefits were observed in prior studies. In the 112 study, the Company observed no significant treatment effect with FX-322 administration compared to placebo. Results showed a favorable safety and tolerability profile and, importantly, that the inclusion of multiple baseline hearing tests prior to treatment mitigated the impact of potential study bias (e.g. placebo response) previously observed in Frequency’s Phase 2a study (FX-322-202). This lead-in approach was also used in the Company’s recently reported open-label study of subjects with mild-to-severe SNHL (FX-322-111). The Company expects to utilize study lead-in measures, and other approaches, to minimize potential bias in future clinical studies.\n\n“To date, Frequency has shown statistically significant hearing benefits in multiple, independent FX-322 studies and these hearing benefits have been observed in s...