Frequency Therapeutics Shares Clinical Data From Exploratory Study Confirming Delivery of FX-322 to the Cochlea
Top-Line Results Show Consistent Drug Entry in All Patients
FX-322 is Frequency’s lead product candidate, designed to regenerate auditory sensory hair cells in the cochlea and improve hearing in patients with sensorineural hearing loss (SNHL). A Phase 1/2 study of FX-322 previously demonstrated statistically significant and clinically meaningful improvements in key measures of hearing function in patients with SNHL.
The exploratory study, initiated late in 2019, was conducted at the
“When we consider these new findings, together with the hearing signal observed in our earlier Phase 1/2 study, we believe we have developed the first known evidence of a pharmacokinetic/pharmacodynamic effect of a potential hearing restoration therapeutic. Through this study we have gained critical insight into the delivery properties of FX-322 and clinical confirmation that it reached the site of action in all study patients,” said
In the study, seven subjects received a single dose of FX-322 at the same dose level given in the Company’s Phase 1/2 study and its ongoing Phase 2a study. Levels of both molecules that make up FX-322 were measured in all patients. The presence of round window membrane mucosal folds in certain subjects did not prevent the entry of FX-322 into the cochlea. Both agents that make up FX-322 were also predicted to achieve therapeutically active drug levels in the high frequency range of the cochlea, based on computer models. Study subjects were followed for approximately 30 days after the procedure and no serious treatment related adverse events were observed.
“Studying perilymph samples from all our cochlear implant patients has helped us to better understand the connection between certain proteins and their association with inner ear disorders. This study has now shown us for the first time that concentrations of a hearing restoration therapeutic candidate can be quantified in perilymph after intratympanic injection, and we believe this novel approach can help accelerate the understanding of therapeutics for the inner ear,” said Prof.
Frequency intends to present the results from this study at an upcoming medical conference.
About Sensorineural Hearing Loss
Sensorineural hearing loss is the most common form of hearing loss, typically resulting from damage to the hair cells in the inner ear that convert sound waves from the inner ear to the brain, impacting millions of individuals in 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 novelty of the exploratory study in
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 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-K filed with the
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