Frequency Therapeutics Holds Virtual R&D Event Highlighting Clinical Advancement of FX-322, a New Potential Restorative Treatment for Hearing Loss and In Vivo Data for Its Remyelination Program in Multiple Sclerosis
Management and Leading KOLs will Provide Detailed Review of Completed FX-322 Clinical Data in Subjects with Sensorineural Hearing Loss (SNHL), Supporting Design of FX-322-208 Phase 2b Study
New Hearing Restoration Program Advances Toward Clinical Studies Providing Broader Cochlear Exposure with the Potential to Address Expanded SNHL Patient Populations
Novel Remyelinating Agent Against a New Biological Target Being Advanced for Multiple Sclerosis (MS); In Vivo Data Show Substantially Greater Activity than Biologic or Small Molecule Comparators
“We look forward to highlighting the extensive data supporting our Phase 2b study (FX-322-208) in patients with sensorineural hearing loss (SNHL), where we have seen clear clinical improvements in speech perception in patient groups that include millions of individuals in the US alone. We have alignment with the FDA on speech perception as the primary efficacy endpoint and will detail the importance of this measure for patients. Our Phase 2b study is enrolling subjects who we believe fit squarely in the range where we have seen clinically meaningful hearing improvements, and we will detail the design of this study,” said
- Clinical data review from four completed FX-322 clinical studies, including 169 subjects with a range of hearing loss severities and SNHL etiologies (sudden, noise-induced, age-related).
- Analysis of statistically significant and clinically meaningful patient responses following a single FX-322 administration, establishing the range of severity and etiologies that will be explored in the upcoming FX-322-208 study.
- Review of design of ongoing FX-322-208 study, including use of multiple lead-in hearing measures implemented to reduce study bias and baseline variability.
Alignment with the
U.S. Food and Drug Administrationaround speech perception measures as a primary efficacy endpoint and the importance of speech perception as the key unmet need for individuals with SNHL.
- Introduction of new SNHL investigational therapeutic program, including a more potent GSK3 inhibitor designed to achieve broader exposure of the cochlea.
- Preclinical pharmacokinetic measures and human modeling data, indicating that therapeutically active FX-345 drug levels will be reached in areas of the cochlea corresponding to a wider range of hearing frequencies.
- Potential to benefit an expanded SNHL patient population.
- IND anticipated in Q2 2022.
Remyelination in Multiple Sclerosis
- Identified novel therapeutic target that drives oligodendrocyte progenitor cell differentiation and myelination.
- FREQ-162, preclinical stage lead compound, induces substantially more remyelination than published, comparator approaches.
- FREQ-162 being advanced in preclinical safety studies toward the initiation of clinical development.
Event Details and Agenda:
The webcast event will be held today,
To register for the event, please visit: https://investors.frequencytx.com/2021_Virtual_R-D_Event. An archived replay will be available for at least 30 days following the presentation.
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 2 trial of FX-322, including the type of SNHL that the enrolled patients will have and the ability of design features to reduce bias, the interpretation and implications of the results and learnings of other FX-322 clinical studies, the acceptance by the FDA of particular endpoints in the Company’s trials, the treatment potential of FX-322, FX-345, and the novel approach for remyelination in multiple sclerosis, the timing and progress of the FX-345 and remyelination programs, the speakers, timing of and topics to be discussed during the R&D event, 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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