Frequency Therapeutics Announces Promising Results for Phase 2b Study of FX-322: A Potential Treatment for Sensorineural Hearing Loss

Frequency Therapeutics Inc. (Nasdaq: FREQ), a regenerative medicine company pioneering treatments to restore function, unveiled promising clinical results from its Phase 2b study of FX-322, a potential therapy for those afflicted with acquired Sensorineural Hearing Loss (SNHL). The placebo-controlled study is a landmark step towards unlocking a person’s innate potential to restore hearing.

FX-322, an innovative potential treatment for hearing loss, was recently tested in a study of 142 people with either sudden or noise-induced sensorineural hearing loss. Unfortunately, the study failed to meet its primary efficacy endpoint of improved speech perception, with no statistically meaningful difference observed between those administered FX-322 and those receiving placebo at day 90. Furthermore, no measurable improvements were seen in any of the study’s secondary endpoints. Although the treatment was found to have a favorable safety profile with no serious adverse events associated with it, the results prove that there is still much work to be done in the search for a successful treatment for hearing loss.

The Company has made the difficult decision to discontinue the FX-322 and FX-345 development programs. However, the Company will instead focus its efforts on advancing its remyelination in MS program into the clinical stage. After the successful completion of dosing for the initial safety cohort of an ongoing Phase 1b trial for FX-345, a second program to treat SNHL, the Company will now direct its resources toward its remyelination in MS program.

Despite the disappointing results, we have decided to cease the further development of our drug candidates for hearing loss. We are grateful to the patients, clinicians, staff, and experts from our clinical advisory board who helped us design and conduct a conclusive study in SNHL. We hope that our research and learnings can be used to benefit the field and eventually lead to successful treatments for hearing loss in the future. Chris Loose, Ph.D., Frequency’s chief scientific officer, stressed the importance of conducting a well-designed and rigorous study to provide a clear outcome.

Frequency is pushing ahead to develop groundbreaking treatments that can induce remyelination in people with MS. The Company has already identified a novel target related to myelination, and multiple novel chemical entities that have been proven to successfully induce remyelination in an adult in vivo animal model. With a distinct molecular target, mechanism, progenitor cell population and small molecule drug candidates, Frequency’s program stands out from the rest. Not only that, but its agents have outperformed other clinically studied remyelination agents in head-to-head in vivo studies. With exciting developments like these, the Company is on track to begin its clinical program for remyelination in 1H 2024.

Frequency is implementing a comprehensive restructuring to extend its runway into 2025 and bring its MS program to clinical trial completion in 2H 2024. This restructuring will involve a reduction of approximately 55 percent of its personnel. Despite this, the Company remains confident that the cost savings generated from the restructuring will be sufficient to achieve its goals. As of December 31, 2022, Frequency had a cash, cash equivalents and marketable securities balance of $83.1 million (excluding restricted cash).

Business Updates

The Company announced today that Chief Executive Officer David Lucchino is on a temporary medical leave after being hospitalized with bacterial meningitis. Thankfully, the prognosis is positive and Mr. Lucchino is expected to make a full recovery and return to his role in the coming weeks. In the meantime, the Board of Directors has appointed Chris Loose, the Chief Strategy Officer, as Interim CEO.

About Frequency Therapeutics

Frequency Therapeutics, based in Lexington, MA, is at the forefront of the regenerative medicine revolution. The company is developing innovative treatments that activate a person’s natural ability to regenerate, with the goal of restoring lost function. Its lead preclinical program seeks to stimulate oligodendrocyte precursor cells, in the hopes of inducing remyelination and improving quality of life for those dealing with multiple sclerosis. This cutting-edge approach could revolutionize the way we think about healing.

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