Frequency Therapeutics said today that the first patients have been treated in a Phase I/II clinical trial to assess its first-in-class drug candidate for hearing restoration.
The 24-patient trial is slated to include people with stable sensorineural hearing loss. Participants will receive an injection of Frequency’s FX-322 or a placebo in one ear, with a follow-up visit after two weeks. After the initial follow-up visit, Frequency plans to monitor participants for another three months.
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.
“This trial marks the first time a PCA drug candidate with the potential to restore hearing has ever been tested in adult humans and gives hope to the 48 million people in the U.S. with stable sensorineural hearing loss,” president, co-founder & CEO David Lucchino said in prepared remarks. “By using a proprietary combination of small molecules intended to awaken dormant progenitor cells, we are creating an entirely new therapeutic modality with the potential to activate the body’s existing regenerative capacity and ultimately cure diseased tissue without the complexities of traditional cell or genetic therapy.”
“This Phase I/II trial builds on the success of our first-in-human study completed last year, which showed FX-322 to be well-tolerated and validated the potential for cochlear penetration when delivered using a standard intratympanic injection in patients scheduled for cochlear implant surgery,” Carl LeBel, EVP of clinical development, added. “The clinical evaluation of FX-322 for hearing restoration is a priority for us based on the unmet medical need of millions of patients around the world who have lost varying degrees of hearing function from chronic noise exposure or sudden hearing loss, and we look forward to reporting the results from this study toward the end of 2018.”
Very encouraging news. I have been wearing hearing aids since 2007 and have had an 11% hearing loss since then. I am told that there is no recovery for the hairs, so this article in the AARP Magizine gives me hope that within a few years I will be able to give up my hearing aids or at least, be able to hear over a wider range of frequencies.
I am also encouraged. I have been wearing hearing aids for about 25 years. Each 4-5 years I end up with more expensive ones and they are still not adequate. If there are more clinical trials I would be willing to participate
I am excited about this an wish to keep up with further developments. I would definitely be interested in participating in any further clinical trials of FX 322.
I want to participate is a clinical trial on FX-322 for hearing loss.
I would also like to participate in clinical trials. This is exciting news. I have had hearing loss for the past fifteen years and it has definitely impacted my life. I’d like to keep up on the progress of these trials.
My husband had sudden hearing loss in rt ear for abt 18 years. Hs impacted his life. Wd be intterested in all info on this and consider clinical trials. We are in green bay wisconsin. Exciting hopeful news!
I’ve been wearing hearing aids since the mid 80’s. Prior to the Veterans Administration Clinic providing my current aids, I’ve purchased top of the line for between $4-6K. I continue to be somewhat dissatisfied with hearing aids.
My single side hearing loss occurred 7 years ago while scuba diving. I would love to participate in a trial. I am a 74-year-old female.
My 1-year old daughter was diagnosed with sensorineural hair loss at birth. I would be glad if the inclusion criteria allow infants. Thank you.