WOBURN, Mass.--(BUSINESS WIRE)--Frequency Therapeutics, Inc. (Nasdaq: FREQ), a clinical-stage biotechnology company focused on harnessing the bodys innate biology to repair or reverse damage caused by a broad range of degenerative diseases, today presented clinical results from a longer-term durability study of FX-322, showing that some patients with chronic sensorineural hearing loss had significant improvement in key measures of hearing that were sustained for up to 21 months.
These new data build upon Phase 1/2 study results previously detailed at the 2019 AAO-HNS conference that showed, for the first time, statistically significant improvements in word recognition (WR) scores in patients with chronic moderate to moderately severe SNHL. These patients had received a single intratympanic dose of FX-322 in a double-blind, placebo-controlled study, and had been evaluated for 90 days. Subsequent testing of a subset of these patients between 13 and 21 months after initial dosing, showed sustained improvements in measures of speech intelligibility (clarity), and in some patients, increased audibility (volume) threshold values at a higher frequency. Susan King, M.D., FACS, the lead investigator on both studies, detailed results today at the AAO-HNSF 2020 Virtual Annual Meeting & OTO Experience.
Historically, patients with acquired chronic SNHL do not regain their lost hearing. The FX-322 Phase 1/2 study has provided promising evidence of clinically meaningful improvements in word recognition, and based on the recent longer-term follow-up data, we believe that this benefit may be sustained for many months following a single dose of this investigational treatment, said Dr. King, co-founder of the Ear Medical Group in San Antonio and Clinical Professor, Department of Otolaryngology, Head and Neck Surgery, The University of Texas Health Science Center at San Antonio. It is exciting to see sustained clinical benefits in these individuals, and while still early, also to see the potential for a therapeutic that may provide sustained speech intelligibility improvement, which remains an unmet need for hearing loss patients.
Four of the patients that were observed to have statistically significant WR scores during the Phase 1/2 study had maintained those improvements in the follow up assessment. Three of these patients remained at statistically significant levels, maintaining an average increase of 87 percent in WR scores from their original baseline levels. The other patient maintained a 71 percent increase from their initial baseline, though that sustained improvement fell outside the range of statistical significance. An additional patient who did not achieve statistically significant change in WR during the Phase 1/2 study was also retested, and it was observed that their WR score had returned to baseline.
Moreover, three of the patients that maintained statistically significant WR scores also showed 10-15dB improvements at 8000Hz compared to their original threshold values at this frequency. The safety profile observed in the FX-322 Phase 1/2 study was favorable and no additional safety findings were observed in the follow-up period. Together, these longer-term clinical data demonstrate the potential for FX-322 to have a durable positive impact both on measures of hearing clarity and volume.
Todays announcement is another important building block as we further our understanding of FX-322s drug potential and the patient populations we hope to treat. In addition to a favorable safety profile, we have generated compelling cochlear drug delivery data, and these newly presented results show that the FX-322 benefit to hearing loss may provide individuals with a long-lasting clinical benefit, said David L. Lucchino, Frequencys chief executive officer. Furthermore, we believe this provides additional evidence supporting the regenerative mechanism of our novel therapeutic approach and a potentially disease modifying treatment. We look forward to sharing data from our ongoing Phase 2a study and to a better understanding of the impact of FX-322 on sound clarity and word recognition that is so critical to hearing health and overall health.
About FX-322 and Sensorineural Hearing Loss
FX-322 is Frequencys lead product candidate for the treatment of acquired SNHL. SNHL impacts more than 40 million people in the U.S. and hundreds of millions of people globally and is the primary cause of more than 90 percent of all hearing loss. Acquired SNHL typically results from damage to the hair cells of the inner ear into signals that are sent to the brain. These auditory sensory hair cells may be lost due to chronic noise exposure, aging, certain viral infections or exposure to drugs that are toxic to the ear. FX-322 is designed to activate progenitor cells (pre-programmed stem cells) and regenerate auditory hair cells in the inner ear (cochlea) to restore hearing function.
FX-322 is currently being evaluated in a Phase 2a study. The FX-322 Phase 2a study is a randomized, double blind, placebo-controlled, single- and repeat-dose study in which the Company plans to enroll up to 96 patients aged 18 to 65 with SNHL. The objectives of the Phase 2a study are to further establish the hearing signal observed in the completed Phase 1/2 study, evaluate the impact of multiple doses and provide deeper insights on endpoints and the appropriate patient population for future studies. FX-322 Phase 2a study subjects are randomized to receive either FX-322 or placebo in one ear, with the untreated ear acting as an additional measure of control. The study is using validated measures of hearing function including word recognition (WR), words-in-noise and pure tone audiometry. Tinnitus and quality-of-life measures will also be evaluated using the Tinnitus Functional Index and the Hearing Handicap Inventory for Adults, respectively. The Phase 2a study has four dose cohorts, and hearing function will be regularly tested over the course of seven months following the first dosing.
The FX-322 Phase 2a study remains ongoing and the Company is expected to report study data in the second quarter of 2021.
About Frequency Therapeutics
Frequency Therapeutics is a leader in the development of medicines designed to activate progenitor cells within the body to treat degenerative diseases. The Companys progenitor cell activation (PCA) approach stimulates progenitor cells to create functional tissue with the aim of developing disease modifying therapies. The Companys lead product candidate, FX-322, is designed to regenerate auditory hair cells to restore hearing function. In a FX-322 Phase 1/2 study, statistically significant and clinically meaningful improvements in key measures of hearing function in patients with sensorineural hearing loss were observed. FX-322 is being evaluated in an ongoing Phase 2a clinical study in patients with sensorineural hearing loss. The Company also is evaluating additional diseases where its PCA approach could create functional tissue, including a discovery program in multiple sclerosis.
Headquartered in Woburn, Mass., Frequency has a license and collaboration agreement with Astellas Pharma Inc. for FX-322, for which it retains U.S. rights, as well as additional collaboration and licensing agreements with academic and nonprofit research organizations including The Scripps Research Institute, Massachusetts Eye and Ear, Mass General Brigham and the Massachusetts Institute of Technology. For more information, visit http://www.frequencytx.com and follow Frequency on Twitter @Frequencytx.
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, pace and timing of enrollment for the Phase 2a clinical trial, the timing of top-line data from the Phase 2a clinical trial, the results and implications of the Phase 1/2 durability of response data, the ability of our technology platform to provide patient benefit, the impact of COVID-19 on the Companys on-going and planned clinical trials and business, increases in headcount, future milestone and royalty payments under the license and collaboration agreement with Astellas, estimates of the size of the hearing loss population and population at risk for hearing loss, the Companys 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 managements 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 Companys ongoing and planned clinical trials, research and development and manufacturing activities, the relocation of the Companys offices and laboratory facilities, the Companys business and financial markets; the Company has incurred and will continue to incur significant losses and is not and may never be profitable; the Companys need for additional funding to complete development and commercialization of any product candidate; the Companys 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 the United States; misconduct by employees or independent contractors; reliance on third parties, including to conduct clinical trials and manufacture product candidates; compliance with laws and regulations, including healthcare and environmental, health, and safety laws and regulations; failure to obtain, maintain and enforce protection of patents and other intellectual property; security breaches or failure to protect private personal information; attracting and retaining key personnel; and ability to manage growth.
These and other important factors discussed under the caption Risk factors in the Companys Form 10-Q filed with the Securities and Exchange Commission (SEC) on August 12, 2020 and its other reports filed with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent managements estimates as of the date of this press release. While the Company may elect to update such forward-looking statements at some point in the future, it disclaims any obligation to do so, even if subsequent events cause its views to change. These forward-looking statements should not be relied upon as representing the Companys views as of any date subsequent to the date of this press release.
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