Frequency Therapeutics, a clinical stage biotechnology company, announced positive results from a Phase 1/2 safety trial to evaluate FX-322, an investigational drug candidate designed to facilitate hearing restoration. The trial assessed the safety of a single dose of FX-322 given by intratympanic administration in adult patients with stable sensorineural hearing loss (SSHL) who had a medical history consistent with either chronic noise exposure or idiopathic sudden sensorineural hearing loss. In the Phase 1/2 study, FX-322 was safe and well tolerated following a single intratympanic injection with no serious adverse events. In addition, improvements in hearing function, including audiometry and word scores, were observed in multiple FX-322 treated patients.

“Hearing loss affects millions of people and current treatments are unable to restore hearing once it is lost,” said Susan Marenda King, MD, a neurotologist at the Ear Medical Group in San Antonio, Texas and lead enroller in the clinical trial. “The study results for FX-322, which show signs of functional hearing improvement, are very promising and represent an exciting step toward a potential treatment for patients.”

“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,” said David L. Lucchino, President, Co-founder and CEO of Frequency. “Furthermore, this data provides support for our small-molecule-driven regenerative medicine platform, which has the opportunity to address numerous degenerative diseases.”

Frequency plans to present the Phase 1/2 results at a major otolaryngology meeting in 2019 and to submit the results for publication. The company believes the results of this study support the advancement of FX-322 into a multiple dose Phase 2a study, which it plans to initiate later this year.

“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.”


The trial was a randomized, double-blind, placebo-controlled, single-dose, multi-center study to assess the safety of FX-322 in 23 patients with stable sensorineural hearing loss. Patients received an intratympanic injection of either a high-dose or low-dose volume of FX-322 or placebo in one ear. Patients were evaluated at an initial follow-up visit two weeks following injection and were monitored for three months. The trial was conducted at several leading otolaryngology clinics in San Antonio, Texas.

Information on the safety clinical trial can be found at with the identification number: NCT03616223.

Source: Frequency Therapeutics, NIH