WOBURN, MASSACHUSSETTS – Biotech startup, Frequency Therapeutics, announced this week the completion of enrollment in the single dose safety trial to evaluate FX-322, the company’s leading drug candidate for hearing restoration. The randomized, double-blind, placebo-controlled trial will be assessing the safety of a single dose of FX-322 given by intratympanic administration in adult patients with stable sensorineural hearing loss (SSHL) who have a medical history consistent with either noise exposure or sudden hearing loss.
According to the company, FX-322 is the company’s lead Progenitor Cell Activation (PCA) candidate for hearing restoration and is described as a “proprietary combination of small molecules designed to transiently activate inner ear progenitor cells and enable the creation of new inner ear hair cells in the cochlea.”
“The advancement of FX-322 from our first study in cochlear implant patients into patient volunteers with stable sensorineural hearing loss should enable us to open our future studies in the office-based setting. If successful, the current study will position us to advance to our Phase 2a program where we’ll be looking to identify and characterize a hearing restoration signal and proof of biological concept in sensorineural hearing loss.”
–Carl LeBel, PhD, Frequency Chief Development Officer
According to the company’s press release, the safety trial is a randomized, double-blind, placebo-controlled, single-dose, multi-center study of FX-322, which was administered in patients with stable sensorineural hearing loss and is being conducted at several leading otolaryngology clinics in the United States. Patients received either an injection of FX-322 or a placebo in one ear with an initial follow up visit after two weeks and will continue to be monitored for the following three months.
“We are pleased with how rapidly we were able to recruit patients with stable sensorineural hearing loss, which is a testament to the support from our Clinical Advisory Board, as well as the enthusiasm of our investigators and the participating patient volunteers,” said David Lucchino, President, Co-founder and CEO of Frequency.
Information on the Phase 1/2 clinical trial being conducted can be found at clinicaltrials.gov with the identification number: NCT03616223.
Source: Frequency Therapeutics