Frequency Therapeutics has treated the first patients in a Phase l/ll clinical trial to investigate the safety of FX-322 for the treatment of patients with sensorineural hearing loss.
As part of the randomised, double-blind, placebo-controlled, multi-centre trial, FX-322 will be provided by intratympanic administration in adult patients with stable sensorineural hearing loss (SSHL) who have a medical history of either with noise exposure or sudden hearing loss.
The trial aims to enrol 24 patients at various otolaryngology clinics in the US.
The enrolled patients will receive either an FX-322 injection or a placebo in one ear with an initial follow up visit after two weeks. They will be kept under observation for the following three months.
Frequency Therapeutics clinical advisory board chairman Dan Lee said: “Hearing loss is a condition that has historically not received much attention despite the widespread nature of the issue, due in part to the difficulty of access to the inner ear environment.
“The early work done by Frequency has shown real potential for FX-322 to have a significant impact in patients with noise induced hearing loss.
“While this is a safety study, it is an important first step to examining FX-322 in adult patients with sensorineural hearing loss.”
The Phase l/ll trial is based on Frequency’s first-in-human study completed last year, which demonstrated FX-322 to be well-tolerated and certified the potential of the drug for cochlear penetration when delivered using a standard intratympanic injection in patients scheduled for cochlear implant surgery.
FX-322 is an investigational drug candidate developed for hearing restoration, using Frequency’s Progenitor Cell Activation (PCA) regeneration platform.