Frequency Therapeutics said today that it finished enrolling participants in a single-dose safety trial for its FX-322 hearing loss drug candidate.
The company’s drug candidate emerged as part of its Progenitor Cell Activation platform – the combination of small molecules are designed to activate progenitor cells and trigger the formation of new hair cells in the inner ear.
The randomized trial is slated to assess the safety of a single dose of FX-322 delivered via intratympanic administration in adult patients with stable sensorineural hearing loss.
“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,” president, co-founder & CEO David Lucchino said in prepared remarks.
Participants enrolled in the study will receive either a dose of FX-322 or a placebo in one ear with a two-week follow-up visit and three months of monitoring, according to Frequency Therapeutics.
“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,” Carl LeBel, chief development officer, added. “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.”