Resources for patients, families and caregivers living with hearing loss
Frequency works with patients to better understand the nature of their hearing loss and how their condition affects their everyday lives. We also partner with a diverse group of organizations both inside and outside the hearing loss space to raise overall awareness of hearing health as a key part of overall health.
What is FX-322 designed to treat?
Frequency’s lead product candidate, FX-322, is designed to regenerate auditory sensory hair cells in the cochlea and help restore hearing in patients with sensorineural hearing loss (SNHL) by improving speech perception. Three clinical studies in which a single dose of FX-322 was administered have shown statistically significant and clinically meaningful improvements in speech perception. In addition, FX-322 was observed to be well-tolerated with no serious adverse effects. We continue to study FX-322 across a broad range of etiologies and populations so we can better understand the individuals our therapeutic candidate may treat.
How can I learn if I am eligible for a clinical trial of FX-322?
Frequency is currently enrolling subjects for a Phase 2b study of FX-322 in patients with noise-induced and sudden sensorineural hearing loss. Those who may be interested in participating may visit this link.
For information regarding ongoing clinical trials evaluating our drug candidates, please refer to http://www.clinicaltrials.gov and follow up with your health care provider. You may search by disease, location of clinical trials, or by the name of the company sponsoring the clinical trials. You may also email [email protected].
When will clinical trials of FX-322 be available in other countries?
Frequency has a strategic agreement with Astellas Pharma, which is responsible for FX-322 development and commercialization programs outside of the United States. Astellas will determine timing for these studies.
When will FX-322 become commercially available?
To stay informed on the status of our clinical studies, please reference our latest press releases and public filings on the Investors & Media section of our website.
Is FX-322 being studied as a potential treatment for tinnitus?
FX-322 is being developed for improvement in speech perception in patients with acquired sensorineural hearing loss. Frequency plans to continue to evaluate tinnitus as an exploratory measure in future clinical trials of FX-322, using the Tinnitus Functional Index (TFI).
Can I get access to FX-322 through expanded access or compassionate use?
Frequency Therapeutics understands that there may be patients interested in obtaining access to our investigational products for treatment under an Expanded Access program. However, at this stage of the development of our products there is insufficient clinical data to support expanded access use and we are unable to manufacture our investigational drugs in the quantities that may be needed for expanded access purposes. Therefore, to ensure availability of materials for clinical trial research and the safety of potential patients, Frequency Therapeutics does not provide access to our investigational products through expanded access currently. For more on this, please refer to our Expanded Access Policy.
When will you release more information on FX-322?
You can reference the latest press releases and public filings available on the Investors & Media section of our website for information regarding upcoming or ongoing clinical trials. If you would like to stay informed about Frequency Therapeutics and any ongoing clinical trials evaluating our drug candidates, please refer to www.clinicaltrials.gov.