Frequency Therapeutics today announced that the first patients have been treated in a Phase 1/2 clinical trial to evaluate FX-322, a first-in-class drug candidate for hearing restoration from the company’s Progenitor Cell Activation (PCA) regeneration platform. The randomized, double-blind, placebo-controlled trial will assess the safety 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.
“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,” said David Lucchino, President, Co-founder and CEO of Frequency. “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. We are thrilled to launch this important trial with the support of our investigators, multiple clinical sites in the U.S. and most importantly the patient volunteers.”
The Phase 1/2 trial is a randomized, double-blind, placebo-controlled, multi-center study of FX-322, which will be administered in patients with stable sensorineural hearing loss. The trial is expected to enroll up to 24 patients at several leading otolaryngology clinics in the United States. Patients will receive 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.
“Hearing loss is a condition that has historically not received much attention despite the widespread nature of the issue, due in part to the difficulty of access to the inner ear environment,” said Dan Lee, M.D., Pediatric and Adult Otology and Neurotology, Massachusetts Eye and Ear Infirmary, Associate Professor of Otolaryngology, Harvard Medical School, and Chairman of Frequency’s Clinical Advisory Board. “The early work done by Frequency has shown real potential for FX-322 to have a significant impact in patients with noise induced hearing loss. While this is a safety study, it is an important first step to examining FX-322 in adult patients with sensorineural hearing loss.”
“This Phase 1/2 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,” said Carl LeBel, Ph.D., Executive Vice President, Clinical Development of Frequency. “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.”
Information on the Phase 1/2 clinical trial can be found at clinicaltrials.gov with the identification number: NCT03616223.
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