Concertgoers, rejoice: An early safety study of Frequency Therapeutics’ hearing loss drug treatment has cleared its first hurdles while showing some signs of hearing improvement in certain patients.
Frequency’s lead candidate, FX-322, is a cocktail of small-molecule drugs designed to activate the body’s healing abilities. By triggering dormant cells within the ear, the treatment hopes to spur the growth of the fine hairs that sense and translate sound waves, which can be damaged over time. The drug showed no serious adverse events in the phase 1/2 study following a single injection given through the eardrum.
Additionally, some adult patients with stable sensorineural hearing loss—with a history of either chronic noise exposure or sudden hearing loss—showed improvements in hearing range tests and word scores compared to placebo, the company said.
Frequency said it plans to publish and present the full study results at an upcoming otolaryngology meeting and launch a phase 2a study of FX-322 before the end of the year.
“While the focus of this study was safety, we are excited to see initial results in sensorineural hearing restoration as there are currently no treatments to restore hearing for these patients,” Frequency’s CEO, president and co-founder David Lucchino said in a statement.
“Furthermore, this data provides support for our small-molecule-driven regenerative medicine platform, which has the opportunity to address numerous degenerative diseases,” Lucchino added.
The double-blind phase 1/2 study randomized 23 patients to high- and low-dose FX-322, as well as placebo. Participants were evaluated two weeks after the injection, and were monitored for three months.
“If successful, our lead development program would represent the first time ever that hearing could be restored in humans with a therapeutic,” said Marc Cohen, Frequency’s executive chairman. “We are defining a new mode of regenerative medicine: activating progenitor cells within your body to repair damaged tissue.”
Frequency secured $42 million in funding through a series B round this past January to advance FX-322’s clinical testing and the company’s regenerative medicine work in other applications.
The round was led by Taiwania Capital Management and Axil Capital, a healthcare-focused venture fund spun out of Mizuho Securities. New backers included Yonjin Capital and DF Investments, while previous investors Polaris Founders Capital, Alexandria Venture Investments, CoBro Ventures, Korea Investment Partners and Emigrant Capital also participated, bringing the company's total funding to $87 million.
Meanwhile, Frequency’s rival in the space, Decibel Therapeutics, recently brought on the company’s former chief medical officer for its own. There, Peter Weber will oversee Decibel’s gene therapy approach to treating hearing loss as well as inner-ear balance issues and tinnitus being developed in partnership with Regeneron Pharmaceuticals.
Frequency instead hired Bill Chin, formerly CMO and executive VP for science and regulatory advocacy at PhRMA, executive dean for research at Harvard Medical School and senior VP for discovery research and clinical investigation at Eli Lilly & Co.