Frequency Therapeutics Stock Craters After FX-322's Four Weekly Regime Shows No Benefit In Sensorineural Hearing Loss

Frequency Therapeutics Inc FREQ stock plunges in the premarket after reporting topline day-90 data from its Phase 2a study (FX-322-202) evaluating the company's lead product candidate FX-322 in sensorineural hearing loss (SNHL).

What Happened: Final results from the Phase 2a study are expected in late Q2 2021. FX-322 is designed to regenerate auditory sensory hair cells in the cochlea and improve hearing in patients with SNHL.

The interim results show that four weekly injections in subjects with mild to moderately severe SNHL did not demonstrate improvements in hearing measures versus placebo.

The four-arm Phase 2a study conducted in 95 subjects demonstrated that while Word Recognition (WR) scores increased across all groups, repeated weekly injections appeared to dampen the hearing benefit observed compared to other single-injection studies.

The interim results also showed an unexpected apparent level of hearing benefit in the placebo group that did not occur in previous trials. They exceeded well-established published standards, potentially suggesting bias due to trial design. No treatment-related serious adverse events were observed in the study. 

Why It Matters: The company also announced new data from a parallel study demonstrating hearing improvement from a single injection of FX-322. It plans to advance further development of FX-322 as a single dose regimen.

Preliminary results from an open-label, single-dose study of FX-322 in 33 subjects that tested hearing function over the course of 90 days showed 34% of subjects achieved a 10% or greater absolute improvement in WR scores in the treated ear, which was clinically meaningful and statistically significant compared to the untreated ear.

The single-dose had a favorable safety profile and was well tolerated. 

Frequency is also conducting a Phase 1b study in age-related hearing loss. The study's primary objectives are to assess the local and systemic safety of a single dose of FX-322 and evaluate hearing responses in an older adult cohort. The results from the Phase 1b study are expected in Q2 2021.

FX-322 Phase 1b study in up to 30 subjects in severe SNHL is also underway, and the results are anticipated in Q3 2021.

Price Action: FREQ shares dropped 72.5% at $9.99 in the premarket session on the last check Tuesday.