FDA Grants Fast Track Status to FX-322 for Sensorineural Hearing Loss

Based on results from the phase 1/2 trial, FX-322 was found to be safe and well-tolerated with no serious adverse events.

The Food and Drug Administration (FDA) has granted Fast Track designation to FX-322 (Frequency Therapeutics) for the treatment of sensorineural hearing loss.

FX-322 is a combination of proprietary small molecules designed to regenerate damaged auditory cells by activating progenitor cells in the inner ear. The investigational treatment is administered intratympanically into the middle ear during an office-based procedure that the Company states takes approximately 10 to 15 minutes.

The designation is based on results from a 3-month, phase 1/2 trial that assessed the safety of FX-322 in adults with stable sensorineural hearing loss (N=23). Patients were randomized to receive either a high-dose or low-dose of FX-322 administered as a single intratympanic injection or placebo in one ear. Results showed FX-322 was safe and well-tolerated with no serious adverse events reported. Additionally, the treatment was associated with statistically and clinically meaningful improvements in hearing function, including clarity of sound and word recognition.

The Company is currently conducting a phase 2a trial to evaluate the efficacy of intratympanic FX-322 that will assess the effectiveness of the treatment on word recognition, words-in-noise, and standard pure tone audiometry. Full study data is expected in the second half of 2020.

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“Starting our phase 2a study shows continued momentum as we further our understanding of the potential of FX-322, both in measures of loudness and clarity, and work to develop a disease modifying treatment for the millions of people living with sensorineural hearing loss,” said David Lucchino, CEO of Frequency Therapeutics. “We are also pleased that the FDA has granted Fast Track designation for FX-322 and we look forward to continuing our ongoing work with the agency as our study progresses.”

For more information visit frequencytx.com.