Updated September 18, 2020: A spokesperson for Frequency Therapeutics contacted Hearing Review to explain that the article inaccurately represents where the company is in developing the drug. They contend that ‘preliminary results’ referenced in the article were from April 9, 2019, when the company announced ‘positive results from a Phase 1/2 safety trial to evaluate FX-322,’ as referenced in a press release. Frequency released ‘new results demonstrating sustained improvement in hearing loss patients treated with FX-322 for up to 21 months after initial dosing,’ according to a September 13, 2020 announcement.
Preliminary results from Frequency Therapeutics’ sensory hair cell regeneration drug, FX-322, show that it “stimulated hearing regeneration in humans for the first time,” according to an article on the WBUR website.
Though encouraging, some clinicians urge caution given the study’s small size.
Related article: Frequency Therapeutics Announces Clinical Data from Auditory Drug
“If it works, it’d be fantastic. We’d all be thrilled,” Dr Bruce Gantz, an otolaryngologist at the University of Iowa who was not involved with the work was quoted as saying in the article. “But it’s such a limited amount of data. I would be very cautious until I did a Phase 3, randomized, controlled clinical trial to figure out if it really works.”
FX-322 is a combination of two molecules designed to affect progenitor cells in the inner ear. The “challenge,” according to WBUR‘s report, will be to get the progenitor cells to begin dividing and generating new cells.
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