Frequency Therapeutics Announces First Subject Dosed in FX-322 Phase 2b Acquired Sensorineural Hearing Loss (SNHL) Study and FDA Agreement on Speech Perception as Primary Endpoint
FX-322-208 is a Randomized, Placebo-Controlled Study to Evaluate Hearing Improvement in Subjects with Acquired SNHL
Company to Host R&D Event on
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.
“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,” said
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 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
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements regarding the design of the new Phase 2b trial of FX-322, including the number of patients that will be enrolled, the type of SNHL that these patients will have, the number of study sites, and the measurements used in the study, the interpretation and implications of the results and learnings of other FX-322 clinical studies, including the FX-322-111, FX-322-201 and FX-322-113 studies, the acceptance by the FDA of particular endpoints in the Company’s trials, the treatment potential of FX-322, the timing of and topics to be discussed during the R&D event, our program to develop a product candidate for the treatment of multiple sclerosis, the ability of our technology platform to provide patient benefit, the ability to continue to develop our Progenitor Cell Activation (PCA) platform and identify additional product candidates, and the potential application of the PCA platform to other diseases.
These forward-looking statements are based on management’s current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: the impact of COVID-19 on the Company’s ongoing and planned clinical trials; research and development and manufacturing activities, the relocation of the Company’s offices and laboratory facilities, the Company’s business and financial markets; the Company has incurred and will continue to incur significant losses and is not and may never be profitable; the Company’s need for additional funding to complete development and commercialization of any product candidate; the Company’s dependence on the development of FX-322; the unproven approach of the PCA platform; the lengthy, expensive and uncertain process of clinical drug development and regulatory approval; limited experience successfully obtaining marketing approval for and commercializing product candidates; the results of earlier clinical trials not being indicative of the results from later clinical trials; differences between preliminary or interim data and final data; adverse events or undesirable side effects; disruptions at the FDA and other regulatory agencies; failure to identify additional product candidates; new or changed legislation; failure to maintain Fast Track designation for FX-322 and such designation failing to result in faster development or regulatory review or approval; costly and damaging litigation, including related to product liability or intellectual property or brought by stockholders; dependence on Astellas Pharma Inc. for the development and commercialization of FX-322 outside of
These and other important factors discussed under the caption “Risk factors” in the Company’s Form 10-Q filed with the
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