HQ Team
December 23, 2022: Frequency Therapeutics, a Boston-based biotech company, has moved to the next stage of its Phase 2 of trials for a drug to treat hearing loss after promising results in its initial research.
The initial trials of the drug known as FX-322 focused on sudden idiopathic hearing loss, or sensorineural hearing loss (SNHL). Sensorineural hearing loss results from damage to the inner ear or the auditory nerve caused by noise exposure, genetic factors or the natural aging process. 90% of hearing loss in adults is a result of sensorineural damage.
Early trials showed good results in participants who had suffered SNHL. The drug known as FX-322 produced significant improvement in speech perception in several participants after a single injection into the inner ear — with some reporting benefits that lasted as long as two years.
The drug stimulates the growth of hair cells in the cochlea, which die down following hearing loss.
The second phase of the trial was not too satisfactory, which the company attributes to a flawed design in the study. Some participants who were given a placebo reported improvements in hearing scores. This showed a bias as participants were already told that they would be given a drug that cures hearing loss. Hence, the participants responded positively to hearing improvement questions even though there was no treatment given.
According to Kevin Franck, senior vice president of strategic marketing and new product planning, who also is a trained audiologist, “There has never been a drug to treat hearing loss, and these measures have never been put to the test in a placebo-controlled trial because you can’t do a placebo-controlled study with hearing devices — you either get the device or you don’t,” said Franck.
“Every time we did [a study], we were breaking new ground, so, of course, there are going to be setbacks,” he said. “We weren’t going to let one problem with study design throw off the promise of a drug that’s got so much potential to help a lot of people,” Franck added.
Investors have shown some concern about the viability of FX-322, but the company is confident of the efficacy of its drug.
The drug has proved safe, with only mild side effects — mostly pain and itching at the injection site, the published studies found.
The primary treatments for all forms of hearing loss hear aids and cochlear implants. These help improve hearing but do not treat the underlying cause of the loss.
This new treatment is less invasive compared to the other two and repairs the loss.
Researchers with Frequency Therapeutics believe a drug that regenerates hair cells and reverses the loss of resolution in the cochlea “would be the holy grail” of hearing loss treatment, Franck added.
For Phase 3 trial, participant enrollment has been completed. If all goes well, the company plans to submit data from the current trial in early 2023 and begin Phase 3 trials soon after.
Frequency Therapeutics has a collaboration agreement with Astellas Pharma for the development and commercialization of FX-322, as well as collaboration and licensing agreements with Massachusetts Eye and Ear, the Massachusetts Institute of Technology, The Scripps Research Institute and Cambridge Enterprises.
