Frequency Therapeutics, Inc. announced that it has dosed a first patient in the Phase 1b study of FX-345, the Company's second hearing restoration candidate for sensorineural hearing loss (SNHL). FX-345 is a combination of two small molecules and, similar to Frequency's lead hearing candidate FX-322, is designed to restore inner ear cells needed for hearing. However, FX-345 includes a more potent GSK3 inhibitor, a new chemical entity that may enable targeted drug exposure further into the cochlea.

Future clinical studies will determine whether greater cochlear drug exposure can address additional populations of individuals with SNHL. The Phase 1b trial, FX-345-101, is a prospective, randomized, single-blind, placebo-controlled, multicenter study to evaluate the safety of FX-345, administered as a single intratympanic injection, in approximately 36 adults aged 18-67, with adult-onset acquired SNHL. The study is divided into two cohorts, with an initial safety cohort of nine subjects designed to provide a rapid assessment of safety and drug exposure.

Pending favorable safety results, a second cohort of 27 subjects will be dosed to continue the safety assessment and evaluate whether FX-345 favorably improves measures of auditory function. Within each cohort, subjects will be randomized 2:1 to receive a single dose of FX-345 or placebo. In pre-clinical studies, pharmacokinetic measures and computer modeling data suggest that FX-345 administration in this trial may result in therapeutically active drug levels in a broad portion of the human cochlea.

The Company anticipates delivering clinical results in the second half of 2023. Frequency is also evaluating FX-322, a therapeutic candidate for SNHL, in an ongoing Phase 2b study (FX-322-208). The prospective, randomized, double-blinded, placebo-controlled, multi-center study is designed to evaluate the efficacy of FX-322 on speech perception in subjects aged 18-65 with hearing loss associated with either noise-induced or permanent idiopathic sudden SNHL.

The study is fully enrolled with 142 participants and clinical results are expected in the second half of first quarter of 2023.