Frequency Therapeutics Virtual R&D Event to Detail FX-322 Clinical Advances, a New Program for Hearing Restoration and In Vivo Data from its MS Remyelination Program
Company to Introduce a Second Hearing Restoration Program with a Differentiated Biological Profile and Greater Coverage into the Cochlea, Providing Potential to Expand Addressable SNHL Patient Populations
Key Research Findings for a Novel Remyelinating Agent Being Advanced for Multiple Sclerosis (MS) also to be Presented
At the event, Frequency’s clinical leaders will provide a detailed review of data from nearly 170 subjects dosed with FX-322. A rigorous statistical analysis of these clinical data uncovered the patient populations most likely to benefit from FX-322 and these patients are now being recruited in the Company’s recently initiated FX-322 Phase 2b study (FX-322-208). Key opinion leaders in auditory science and clinical study design will provide insights on FX-322 clinical results and the strategy supporting the new FX-322-208 trial.
The FX-322-208 study is designed to demonstrate improved speech perception in an enriched population of individuals with SNHL where statistically significant and clinically meaningful hearing improvements in speech perception were observed in prior trials. The
In addition to discussing clinical development advances, the company will unveil two new advanced research programs:
- A new candidate to treat sensorineural hearing loss that delivers a regenerative therapeutic that may provide greater coverage and increased potency at the site of action within the inner ear, that may enable the treatment of different SNHL patient populations at varying dose levels and;
- A novel approach for remyelination in multiple sclerosis, including in vivo findings showing potent biological activity and a comparison of this program to other leading approaches.
Event Details and Agenda:
The webcast event is scheduled for
David L. Lucchino, Chief Executive Officer: Strategic Companyoverview.
Robert S. Langer, ScD, a Frequency Therapeuticsscientific co-founder and MIT Institute Professor: Pioneering a new category in regenerative medicine.
Carl LeBel, PhD, Chief Development Officer: FX-322 hearing restoration program and the clinical development path.
Sumit Dhar, PhD, Hugh Knowles Professorof Hearing Science and Associate Provost for Faculty at Northwestern University: Cochlear pathology and the impact of high frequencies on speech perception.
Kevin Franck, PhD, SVP, Strategic Marketing and New Product Planning: FX-322 clinical data and review of responders.
Steven D. Targum, MD, Scientific Director, Signant Health: Best-practice approaches for addressing placebo response in clinical trials.
Christopher Loose, PhD, Chief Scientific Officer: Continued progenitor cell activation (PCA) research, drug delivery advances and overview of a new regenerative hearing program.
Sanjay Magavi, PhD, VP, Myelination Research: In Vivo data for a novel pre-clinical program for remyelination in multiple sclerosis.
To register for the virtual event and watch a live webcast of the presentation, please visit the Investor’s & Media section of the
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, 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 as well as the novel approach for remyelination in multiple sclerosis and our new candidate to treat SNHL, 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