Frequency Therapeutics to Host Investor Event on the Potential for Restorative Treatments for Acquired Sensorineural Hearing Loss
Event to be Held
Phase 2a Day-90 Readout for FX-322, Frequency’s Lead Product Candidate, for Acquired Sensorineural Hearing Loss Anticipated in Late Q1 2021; End of Study Readout in Late Q2 2021
Leading researchers and clinicians, along with Company executives, will discuss current interventions for the treatment of acquired sensorineural hearing loss (SNHL), unmet medical needs for hearing loss patients and the potential of FX-322 to transform the current standard of care.
Presenters to include:
Robert S. Langer, Sc.D., Scientific Co-Founder; Member of Frequency’s Board of Directors; David H. Koch Institute Professor, Massachusetts Institute of Technology Lawrence R. Lustig, M.D., Chair, Department of Otolaryngology– Head and Neck Surgery, Columbia University René H. Gifford, Ph.D., Professor, Hearing and Speech Sciences, Director, Cochlear Implant Program, Vanderbilt University Frank Lin, M.D., Ph.D., Director, Cochlear Center for Hearing and Public Health, Johns Hopkins Bloomberg School of Public Health
FX-322 is being evaluated in an ongoing double-blind, placebo-controlled, single and repeat dose Phase 2a study in patients aged 18 to 65 with mild to moderately severe acquired SNHL. Frequency expects to share day-90 results from the study in late Q1 2021 and end of study results in late Q2 2021. Acquired SNHL is the primary cause of more than 90 percent of all hearing loss, impacting more than 40 million people in the US alone. Efficacy measures for the Phase 2a study include speech intelligibility (clarity), as measured by standard, validated word recognition (WR) and words-in-noise (WIN) testing. Exploratory efficacy measures include pure tone audiometry at extended high frequencies (up to 16kHz) that are known to contribute to speech intelligibility, as well as assessments of tinnitus and quality of life measures.
The Company is also conducting two Phase 1b clinical studies to evaluate the potential of FX-322 to provide benefit to additional patient groups, including patients with age-related hearing loss, and individuals with severe SNHL. Clinical study results are also expected in Q2 2021 for a Phase 1b study of FX-322 in patients with age-related hearing loss and in Q3 2021 for the Phase 1b study in patients with severe SNHL.
To join the webcast and live Q&A 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 Phase 2a clinical trial, the Phase 1b study of age-related hearing loss, the Phase 1b study of severe SNHL, design, pace and timing of enrollment for the Phase 1b studies in age-related hearing loss and severe SNHL, the timing and completeness of data readouts from the Phase 2a clinical trial and the Phase 1b studies in age-related hearing loss and severe SNHL, the impact of COVID-19 on the Company’s on-going and planned clinical trials and business, estimates of the size of the hearing loss population and population at risk for hearing loss, the Company’s ability to advance its hearing program and further diversify its portfolio 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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