Frequency Therapeutics (Nasdaq:FREQ) shares were down more than 80% on Monday afternoon after the company announced the failure of the Phase 2b study for FX-322, its lead candidate drug for hearing loss. As a result, the Lexington, Massachusetts-based biotech company will discontinue its hearing loss program and cut its workforce by 55%.
It says its cost savings measures will extend its runway into 2025.
In late 2022, Otonomy, another neurotology biopharma once listed on Nasdaq, said it had decided to dissolve its business and liquidate its assets.
FX-322 had no statistically significant difference over placebo
Frequency Therapeutics said the Phase 2b study showed that the drug FX-322 did not improve speech perception more than placebo. The company will also discontinue its second program for sudden or noise-induced sensorineural hearing loss, FX-345.
FX-322 did not meet its primary endpoint or any of the study’s secondary endpoints. The safety profile of FX-322 was favorable and no adverse events were associated with treatment.
Frequency was founded to develop a new category of therapeutic drugs designed to stimulate existing progenitor cells in the body to promote production of functional and healthy tissues and organs.
Refocusing on MS
The company said it would focus its resources on developing novel therapeutics for inducing remyelination in multiple sclerosis (MS) patients. Frequency reports having discovered a novel target related to myelination. It has found multiple chemical entities that induce strong remyelination after demyelination in adult animals. This MS program is separate from the hearing program and has its own molecular target, mechanism, cell population and drug candidates.
Frequency hopes to begin its clinical program for remyelination in the first half of 2024.
The company also said that its CEO, David Lucchino, has taken temporary medical leave as he was hospitalized with bacterial meningitis. He is expected to fully recover and return to work in the near future. In the interim, Chris Loose, the company’s chief scientific officer, will serve as the interim CEO.
Frequency was founded in 2014.
Filed Under: ENT drugs