Frequency to Restructure, Focus on MS Therapy

Lexington’s Frequency Therapeutics has announced that the Phase 2b study of its hearing loss therapy FX-322 has failed to meet its primary endpoint. As a result, the company will discontinue the FX-322 development program along with a related program. Frequency’s efforts will now focus on continuing to develop novel therapeutics to induce remyelination for individuals living with MS.

The MS program is independent of the hearing program, with a distinct molecular target, mechanism, progenitor cell population, and small molecule drug candidates. Further, a well-defined clinical path with objective biomarkers exists for studying the performance of remyelination therapies in MS patients. Frequency’s agents substantially outperform other clinically studied remyelination agents in head-to-head in vivo studies. Frequency plans to begin its clinical program for remyelination in early 2024.

The company will immediately reduce headcount as part of an overall restructuring, downsizing personnel by approximately 55 percent, and believes that 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 2024. (Source: Frequency Therapeutics Website, 13 February, 2023)