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2021-03-27| Trials & Approvals

Frequency Looks to Refocus After Sensorineural Hearing Loss Drug Suffers Setback

by Judy Ya-Hsuan Lin
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Sensorineural hearing loss (SNHL) is the most common type of hearing loss that impacts millions of people worldwide. It results from damage to auditory sensory hair cells in the inner ear. The cells are important for converting sound waves to a signal recognized by the brain and could be damaged by chronic noise exposure, aging, and viral infections.

Previously, renowned researchers Bob Langer and Jeff Karp conceived the idea of utilizing small molecules to activate and differentiate stem cells to proliferate the growth of sensory cells. The idea was successfully transformed into a real therapeutics FX-322 to treat SNHL by Massachusetts-based Frequency Therapeutics, as demonstrated in its Phase 1/2 data.

Following the triumph of the single-dose Phase 1/2 study of FX-322, Frequency Therapeutics launched its Phase 2a study to evaluate the hearing improvement of 95 participants aged 18-65. On March 23, the company announced that the four-weekly consecutive injection of FX-322 in the Phase 2a study, unfortunately, did no better than placebo. This had the company’s stock fall as much as 72% in premarket trading.

“The results clearly demonstrated that a treatment regimen using four weekly injections is unfavorable and we will continue to move ahead with single-dose administrations in future studies. We believe in the potential of FX-322 given the demonstrated hearing signal and favorable safety profile observed with a single dose and in the future, we may evaluate re-treatment at longer intervals,” said David L. Lucchino, Frequency’s President, and Chief Executive Officer.

Burgeoning Since 2019

The current setback hopefully does not strike Frequency Therapeutics too much, as the company has had a fundamentally strong history since 2019 when Phase 1/2 trial demonstrated a significant improvement of word recognition scores among its participants in April 2019.

Just six months after obtaining a $42 million Series B round earlier that year, Frequency Therapeutics raised $62 million in the Series C round to advance FX-322 in partnership with Astellas for Phase 2 trials. Three months later, Astellas paid $80 million for the ex-U.S. rights to FX-322. The total yield of $147 million gave Frequency the funds to launch the Phase 2 study.

Ongoing Clinical Trials

Frequency will now focus on independent, single-dose studies of the drug candidate. The Phase 1b study (FX-322-112) will assess the local and systemic safety of a single dose of FX-322 in an older adult cohort aged 66-85 by the second quarter of 2021, while Phase 1b study (FX-322-113) evaluates on 18-65 age group by the third quarter of 2021; each with a total of 30 enrollees.

“More single dose studies are underway to further understand the potential benefit of FX-322 in additional patient populations. Frequency is well resourced, and with the support of our collaborator Astellas Pharma, we will continue to advance development of potential hearing restoration therapeutics for the millions of individuals impacted by sensorineural hearing loss,” added Lucchino.

By Judy Ya-Hsuan Lin

Related Article: Successful Gene-Editing to Reverse Deafness Scores Another Win for Gene Therapy

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