LEXINGTON, MASSACHUSSETTS — Frequency Therapeutics, Inc. (Nasdaq: FREQ), a clinical-stage regenerative medicine company focused on developing therapeutics to activate a person’s innate regenerative potential to restore function, today announced that the first subject has been dosed in a new FX-322 Phase 2b study (FX-322-208) being conducted in a refined population of individuals with sensorineural hearing loss (SNHL).
FX-322-208 is a randomized, placebo-controlled, multi-center study designed to evaluate the impact of a single administration of FX-322 on speech perception in approximately 124 subjects with SNHL. The study’s primary endpoint is speech perception, a measure of sound clarity and understanding speech.
The Phase 2b study’s inclusion criteria are designed to enroll subjects with the same hearing loss severities and etiologies as those subjects in which statistically significant improvements in speech perception were observed in prior FX-322 clinical studies. FX-322-208 will include subjects with hearing loss associated with either noise-induced or sudden SNHL.
FDA Agreement on Endpoint
The U.S. Food and Drug Administration (FDA), in a recent Type-C meeting with the Company, agreed that speech perception is an acceptable primary efficacy endpoint. A variety of other listening tests, including multiple measures of speech perception and pure tone thresholds, will also be assessed.
“The FX-322-208 Phase 2b study incorporates learnings from all of our prior studies, enabling us to identify targeted patient populations and prior responder groups for evaluation. We are testing FX-322 in subjects with hearing loss severities and etiologies where we have seen improvements in past trials. We have also applied key additional design elements to the study to mitigate potential bias and help ensure the consistency of baseline hearing assessments. Moreover, we are very pleased to have obtained alignment with the FDA on speech perception as the primary endpoint for our upcoming studies, given the important need for treatments that can provide greater hearing clarity. In a recently held externally-led Patient Focused Drug Development program with FDA, sponsored by the Hearing Loss Association of America, patients made clear that medicines that could restore hearing and that can enable greater speech perception were critical to advancing the current standard of care. We believe we now have a clear path forward to deliver on this common goal.”
–David L. Lucchino, Frequency’s Chief Executive Officer
Mr. Lucchino continued: “In November, we look forward to presenting the detailed clinical findings that support the design of FX-322-208, as well as discussing our broader R&D efforts as we expand our pipeline in hearing loss as well as other disease areas where we have seen real promise from our technology.”
FX-322: Promising Results from Prior Clinical Studies
In two previous clinical studies, the company observed statistically significant improvements in speech perception scores in individuals with acquired sensorineural hearing loss. These studies are FX-322-201, a randomized placebo-controlled study of subjects with mild to moderately severe SNHL, and FX-322-111, an open-label study evaluating different FX-322 administration conditions, where nine of 32 subjects that completed the study showed speech perception improvements between 90 days and one year following administration.
To date, more than 175 individuals have been dosed with FX-322 across previous studies and no drug-related serious adverse events have been reported.
The company says it will maintain flexibility in the overall FX-322-208 design in order to be able to include additional etiologies and severities based on pending results from its ongoing FX-322 study in severe subjects (FX-322-113).
FX-322-208 is expected to be conducted at approximately 25 U.S.-based study sites consisting of both private ENT clinics and academic medical centers.
Additional study details are available at clinicaltrials.gov (NCT05086276).
Frequency plans to host an R&D event on November 9, 2021, where the Company will review detailed FX-322 clinical results and discuss the data supporting the design and inclusion criteria for FX-322-208.
About Frequency Therapeutics
Frequency Therapeutics is leading a new category in regenerative medicine that aims to restore human function – first in hearing loss and then in multiple sclerosis (MS) – by developing therapeutics that activate a person’s innate regenerative potential within the body through the activation of progenitor cells. Frequency’s hearing research focuses on cochlear restoration and auditory repair, and its lead asset, FX-322, is a small-molecule product candidate that is the first to show statistically significant and clinically meaningful hearing improvements in clinical trials for sensorineural hearing loss. Frequency is also following early restorative signals in MS to develop medicines with the same underlying regenerative science being brought to hearing loss.
Headquartered in Lexington, Mass., Frequency has an ex-U.S. license and collaboration agreement with Astellas Pharma Inc. for FX-322, as well as additional collaboration and licensing agreements with academic and nonprofit research organizations including Massachusetts Eye and Ear, Mass General Brigham, the Massachusetts Institute of Technology, the Scripps Research Institute and Cambridge Enterprises Limited.
Source: Frequency Therapeutics