FX-322 for Hearing Loss

No longer recruiting at 27 trial locations

Overseen By Clinical Trials Information Desk

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Frequency Therapeutics

Must not be taking: Platinum chemotherapy, Aminoglycosides

Disqualifiers: Tympanic disorders, Conductive hearing loss, Middle ear disease, Auditory neuropathy, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 91

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called FX-322 for individuals with acquired sensorineural hearing loss, often caused by loud noise exposure or sudden hearing issues. The researchers aim to determine if FX-322, administered as an injection into the ear, can improve hearing compared to a placebo (a harmless substance used for comparison). It is suitable for adults who have had hearing loss confirmed by a hearing test at least 6 months ago and who experience difficulty hearing everyday sounds. Participants should not have certain ear conditions or have received recent ear injections. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that FX-322 has been generally well-tolerated in past studies. Data from earlier trials indicated that injecting FX-322 into the ear was safe. Participants in these studies did not experience significant side effects compared to those who received a placebo.

Although the treatment has not demonstrated a major improvement in hearing compared to a placebo, its safety and tolerability have remained consistently positive. No serious safety issues emerged in these trials, suggesting that FX-322 could be a safe option for people with hearing loss. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

FX-322 is unique because it aims to regenerate hair cells in the inner ear, a novel approach compared to standard treatments like hearing aids or cochlear implants, which only amplify sound or bypass damaged cells. Researchers are excited about FX-322 because it uses small molecules to target progenitor cells, potentially restoring natural hearing function. This treatment could revolutionize how we address sensorineural hearing loss by treating the root cause rather than just alleviating symptoms.

What evidence suggests that FX-322 might be an effective treatment for sensorineural hearing loss?

Research has shown that FX-322, a treatment under study in this trial, can improve speech understanding in individuals with hearing loss when applied to a specific part of the inner ear. Some studies have found that it enhances speech clarity in those with stable sensorineural hearing loss (SNHL). However, other trials have yielded mixed results, with FX-322 not consistently demonstrating clear benefits for hearing improvement. Despite these challenges, the treatment aims to regenerate inner ear cells to help restore hearing. Overall, the evidence is still developing, but early signs suggest that FX-322 could benefit some individuals with hearing loss. ^{1 2 4 6 7}

Who Is on the Research Team?

Carl LeBel, PhD

Principal Investigator

Frequency Therapeutics

Are You a Good Fit for This Trial?

Inclusion Criteria

The subject has read and agreed to the terms of the Informed Consent Form, answering any questions they may have about the study

Female subjects must either not be able to have children or must use two methods of contraception, like hormonal contraception and a condom, or they must remain abstinent

The subject seems to be able to communicate effectively with the researcher and is willing to comply with all the study procedures.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single intratympanic injection of FX-322 or placebo

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

Multiple visits (in-person) through Day 90

What Are the Treatments Tested in This Trial?

Interventions

• FX-322
• Placebo

How Is the Trial Designed?

Group I: FX-322 Active Control 1 Intervention

FX-322, 1 dose

Group II: Placebo Placebo Group 1 Intervention

Placebo, 1 dose

Who Is Running the Clinical Trial?

Frequency Therapeutics

Lead Sponsor

Trials

7

Recruited

340+

Published Research Related to This Trial

The study analyzed adverse event (AE) data from six randomized controlled trials involving schizophrenia treatments, highlighting that the absolute prevalence and expected duration of AEs provide a more comprehensive understanding of a drug's safety compared to just incidence rates.

Using a new metric to assess the drug-placebo difference in AE prevalence, the research found that some AEs not listed in the standard drug label significantly impacted drug tolerability, suggesting that including these metrics in drug labels could enhance safety signal detection and inform better treatment choices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Novel Method for Deriving Adverse Event Prevalence in Randomized Controlled Trials: Potential for Improved Understanding of Benefit-Risk Ratio and Application to Drug Labels. Piacentino, D., Ogirala, A., Lew, R., et al.[2023]

In a review of 109 clinical studies with 1228 healthy volunteers, 19% reported adverse events during placebo administration, highlighting that even without active treatment, participants can experience side effects.

Adverse events were more common with repeated dosing (28%) and among elderly participants (26%), with headaches, drowsiness, and asthenia being the most frequently reported issues, indicating that placebo effects can significantly influence safety evaluations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The placebo effect in healthy volunteers: influence of experimental conditions on the adverse events profile during phase I studies. Rosenzweig, P., Brohier, S., Zipfel, A.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8279894/

Improved Speech Intelligibility in Subjects With Stable ... Delivery of FX-322 to the extended high-frequency region of the cochlea is well tolerated and enhances speech recognition performance in multiple subjects with ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05086276

FX-322 in Adults With Acquired Sensorineural Hearing Loss This is a Phase 2, prospective, randomized, double-blind, placebo-controlled, single-dose, multicenter study to evaluate the efficacy of FX-322, ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04629664

FX-322 in Adults With Severe Sensorineural Hearing Loss This is a Phase 1b placebo-controlled, double-blind, single-dose safety study of intratympanic FX-322 dosed in subjects with severe sensorineural hearing ...

4. healthyhearing.com healthyhearing.com/report/52745-New-drug-cocktail-may-be-future-treatment-for-sensorineural-hearing-loss

Hearing loss drug FX-322 fails to show benefit in clinical trial Frequency Therapeutics halted its clinical trial for the experimental hearing loss drug FX-322 due to disappointing clinical trials results.

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33617194/

Improved Speech Intelligibility in Subjects With Stable ... Delivery of FX-322 to the extended high-frequency region of the cochlea is well tolerated and enhances speech recognition performance in multiple subjects with ...

6. biospace.com biospace.com/frequency-therapeutics-releases-new-data-from-two-fx-322-clinical-studies-plans-to-advance-single-dose-regimen/

Frequency Therapeutics Releases New Data from Two FX-322 ... The single dose had a favorable safety profile and was well tolerated. These latest results are supportive of the data reported in the prior single dose Phase 1 ...

7. hearingreview.com hearingreview.com/inside-hearing/industry-news/frequency-therapeutics-updates-progress-on-hearing-loss-treatments

Frequency Therapeutics Updates Progress on ... While the treatment effect was not significant compared to placebo, results from the FX-322-112 study showed a favorable safety and tolerability profile; no ...