FX-322 in Adults With Acquired Sensorineural Hearing Loss - Full Text View.

There are no approved pharmacologic therapies for chronic sensorineural hearing loss (SNHL). The combination of CHIR99021+valproic acid (CV, FX-322) has been shown to regenerate mammalian cochlear hair cells ex vivo. The objectives were to characterize ...

February 13, 2023 - Frequency Therapeutics Inc. has announced the cessation of its FX-322 and FX-345 programs designed to help people with sudden or noise-induced sensorineural hearing loss (SNHL) only a few months after biotech hearing loss developer Otonomy closed its doors. What does this mean for people with ...

February 15, 2023 - Frequency Therapeutics halted its clinical trial for the experimental hearing loss drug FX-322 due to disappointing clinical trials results.

February 13, 2023 - (RTTNews) - Frequency Therapeutics, Inc. (FREQ) reported clinical results from the placebo-controlled Phase 2b study of FX-322 in individuals with acquired Sensorineural Hearing Loss. The study failed to achieve its primary efficacy endpoint of an improvement in speech perception

February 13, 2023 - FX-322-208 Study Fails to Meet Primary Endpoint, Showing No Significant Separation in Speech Perception Between FX-322 and Placebo Company Will Now Focus on Advancing its Program in Remyelination for Multiple Sclerosis (MS) Announces Corporate Restructuring and Will Also Explore Strategic

Delivery of FX-322 to the extended high-frequency region of the cochlea is well tolerated and enhances speech recognition performance in multiple subjects with stable chronic hearing loss.

profile of CV in guinea pigs, then measure FX-322 in human perilymph samples, and finally assess safety and audiometric effects of FX-322 in humans with chronic SNHL. Study Designs: Middle ear residence, cochlear distribution, and elimination profiles of FX-322 were assessed in guinea pigs.

Eligibility: Participants must be between 18-65 years old with an established diagnosis of stable sensorineural hearing loss by standard hearing tests. Goal: To evaluate a new investigational medication called FX-322 that is delivered directly in the ear through the eardrum.

February 13, 2023 - (Nasdaq: FREQ), a regenerative medicine company focused on developing therapeutics to activate a person’s innate potential to restore function, today announced clinical results from the placebo-controlled Phase 2b study of FX-322 in individuals with acquired Sensorineural Hearing Loss (SNHL).

August 14, 2023 - Just last month, Korro Bio agreed to combine with Frequency Therapeutics through a reverse merger set to close in the fourth quarter. Frequency’s former lead candidate FX-322 in February failed a Phase IIb trial (FX-322-208; NCT05086276) in patients with acquired sensorineural hearing loss.

September 22, 2021 - In Follow-Up to Phase 1b Learning Study (FX-322-111), Some Subjects with Sensorineural Hearing Loss Show Increased Speech Perception Up to Twelve Months After Dosing LEXINGTON, Mass. --(BUSINESS WIRE)--Sep. 22, 2021-- Frequency Therapeutics, Inc. (Nasdaq: FREQ), a clinical-stage regenerative

December 15, 2022 - Pioneering RNA editing to deliver the future of medicine · RNA editing holds great promise to rewrite what’s possible for patients. Since the discovery of the first generation of editing technologies, researchers have been working to overcome the inherent complexity of these initial approaches ...

February 14, 2023 - Shares of US regenerative medicines firm Frequency Therapeutics (Nasdaq: FREQ) plummeted more than 80% to $0.75 yesterday, after it announced it is terminating programs in sensorineural hearing loss (SNHL) because FX-322 failed to meet the goal of a study in people with acquired SNHL, and is ...

October 20, 2021 - Study record managers: refer to the Data Element Definitions if submitting registration or results information

October 20, 2021 - Study record managers: refer to the Data Element Definitions if submitting registration or results information

February 14, 2023 - Frequency was testing its hearing loss therapy, FX-322, in patients who have sensorineural hearing loss (SNHL), which is caused by damage to the tiny hair cells in the ear that turn vibrations into the electrical signals sent to the brain via the auditory nerve.

May 5, 2022 - These milestones include: FX-322 Phase 2b study results in hearing restoration, which are anticipated in Q4 2022 or Q1 2023; Phase 1 study results of FX-345, our second hearing restoration program that aims to distribute drug deeper into the cochlea and potentially treat additional individuals ...