- Frequency Therapeutics Inc FREQ announced clinical results from the Phase 2b study of FX-322 in individuals with acquired Sensorineural Hearing Loss (SNHL).
- The study, which enrolled 142 people with either sudden or noise-induced sensorineural hearing loss, failed to achieve its primary efficacy endpoint of improving speech perception.
- Data showed no statistically meaningful difference at day 90 between those administered FX-322 versus those receiving a placebo in the proportion of individuals that demonstrated an improvement in speech perception.
- No measurable improvements were observed in any of the study’s secondary endpoints.
- The safety profile associated with FX-322 was favorable, and no study participants experienced a serious adverse event that was associated with treatment.
- Frequency Therapeutics 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 on advancing its remyelination in the multiple sclerosis program in the clinic.
- It plans to begin its clinical program for remyelination in 1H 2024.
- FREQ will immediately reduce headcount as part of an overall restructuring, downsizing personnel by approximately 55%, extending its runway into 2025, and enabling it to complete the first clinical trial of its MS program in 2H 2024.
- It had cash, cash equivalents, and marketable securities of $83.1 million.
- Price Action: FREQ shares are down 80.2% at $0.78 on the last check Monday.
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