Following a fail phase 2 study, Frequency Therapeutics is walking away from its sensorineural hearing loss (SNHL) development programs and refocusing its resources on remyelination for individuals living with Multiple Sclerosis.
The Massachusetts-based regenerative medicines company reported that the FX-322-208 study, which enrolled 142 people with either sudden or noise-induced sensorineural hearing loss, failed to achieve its primary efficacy endpoint of an improvement in speech perception. According to Frequency, data showed no statistically meaningful difference at day 90 between those administered the small-molecule combination product candidate versus those receiving placebo . There were also no measurable improvements observed in any of the study’s secondary endpoints
As such, the company will now discontinue the FX-322 development program, as well as FX-345, a second program, currently in phase 1. Frequency’s efforts now will focus on continuing to develop novel therapeutics to induce remyelination — spontaneous repair in the central nervous system — for individuals living with multiple sclerosis.
This will trigger an immediate reduction in headcount as part of an overall restructuring by approximately 55%. Frequency hopes the restructuring will generate sufficient cost savings to extend its runway into 2025 and enable it to complete a first clinical trial of its MS program in the second half of 2024.
