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.”