• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar
  • Skip to footer
  • Advertise
  • Subscribe

Drug Delivery Business

  • Clinical Trials
  • Research & Development
  • Drug-Device Combinations
  • FDA
  • Pharmaceuticals
  • Policy

Frequency touts first-in-human safety study for hearing loss therapy

January 2, 2018 By Sarah Faulkner

Frequency Therapeutics

Frequency Therapeutics has finished a first-in-human study of its progenitor cell activation therapy, FX-322, in nine adults with severe to profound sensorineural hearing loss.

The company’s candidate is a combination of small molecules that are designed to activate progenitor cells and trigger the formation of new hair cells in the inner ear.

The patients enrolled in the trial were all scheduled to receive a cochlear implant within 24 hours of intratympanic injection of Frequency’s therapy. Researchers evaluated the safety of administering FX-322 while the patient was awake and also assessed the compound’s local and systemic bioavailability.

“The goal of this landmark first-in-human study was to prove the safety and tolerability of FX-322 at a dose that has been effective in restoring hearing in animals,” lead investigator Dr. Stephen O’Leary said in prepared remarks.

“This goal was achieved by showing that FX-322 was well tolerated with no drug related adverse events reported. Further, the results validated the feasibility of using a standard intratympanic injection to deliver FX-322 locally to the inner ear. In addition, we found that FX-322 successfully diffused from the middle ear to the perilymph fluid in the cochlea with minimal systemic drug exposure.”

“FX-322 has transformative therapeutic potential, as it is designed to activate dormant progenitor cells in the inner ear so that they will multiply and mature into new, fully functional hair cells to restore hearing,” chief medical officer Dr. Peter Weber added. “This is the first time a progenitor cell activator has been looked at in humans, and these promising results bode well for the continued development of FX-322 for hearing restoration and other potential PCA™ therapeutics to address additional disease indications.”

“Our Phase I study provides crucial data on safety and pharmacokinetics associated with intratympanic delivery of FX-322 as we move forward to clinical trials to monitor efficacy,” Dr. Daniel Lee, chair of Frequency’s clinical advisory board, said. “FX-322 represents a new class of targeted small molecule therapies in Frequency’s PCA™ portfolio with the potential to transform the field of regenerative medicine.”

“The completion of this study is a milestone for the clinical development of FX-322, a first-of-its-kind candidate with the potential to treat hearing loss for millions of people,” co-founder, president & CEO David Lucchino touted.

“Frequency is pioneering the field of PCA regenerative medicine to tackle a wide range of disease indications where no effective therapeutic solutions are available. The successful study in Australia validates our groundbreaking approach and sets the stage for our development of more progenitor cell activators for additional disease indications. We are grateful for the tremendous efforts made by the team at Frequency, our clinical investigators and most importantly the patients who have volunteered to undertake this revolutionary endeavor.”

Want to stay on top of DDBN content? Sign up for our e-mail newsletter for a weekly dose of drug-device news.

Filed Under: Clinical Trials, Drug-Device Combinations, Featured, Otolaryngology Ear, Nose & Throat, Pharmaceuticals Tagged With: Frequency Therapeutics

IN CASE YOU MISSED IT

  • Insulet hires new chief HR officer from J&J
  • Breakthrough T1D, Mattel debut Barbie doll with type 1 diabetes
  • Medtronic Diabetes names CFO with consumer experience ahead of separation
  • Diabeloop launches insulin delivery algorithm in Germany
  • GlucoModicum has positive data for needle-free CGM

Reader Interactions

Comments

  1. Frank Adornato says

    May 4, 2019 at 8:50 am

    I have severe hearing loss and I am interested in your trial drug FX332. Please send me updates on the results of your trials, as well as patient inclusion criteria for a future study. I live in St. Peterbsurg Florida.

  2. Hyla says

    July 18, 2019 at 7:11 am

    I was diagnosed with hearing loss at the Cleveland clinic . Please contaxt me . I would be interested . Thank you

Primary Sidebar

“ddb
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest news and trends happening now in drug delivery.

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.

Footer

Drug Delivery Business News Logo

MassDevice Medical NETWORK

MassDevice
DeviceTalks
Medical Tubing + Extrusion
Medical Design & Outsourcing
MedTech100 Index
Drug Discovery & Development
Pharmaceutical Processing World
Medical Design Sourcing
R&D World

DRUG DELIVERY BUSINESS NEWS

Subscribe to Drug Delivery’s E-Newsletter
Advertise with us
About
Contact us
Privacy
Listen to our Weekly Podcasts

Copyright © 2025 · WTWH Media LLC and its licensors. All rights reserved.
The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media.

Privacy Policy | RSS