The CURE for Hearing Loss: Part 2 | FX-322 Drug. Dr. Cliff Olson, Audiologist and founder of Applied Hearing Solutions in Phoenix Arizona, discusses the progress of the first possible Cure for Sensorineural hearing loss – FX322.
The First Cure for Hearing Loss: Part 1 – https://youtu.be/L9TpruwH1r0
Frequency Therapeutics: https://www.frequencytx.com/
FX 322 Clinical Trials: https://clinicaltrials.gov/ct2/show/NCT04120116?term=fx+322&draw=2&rank=2
About 6 months ago I made a video about an exciting new Drug that may be able to actually REVERSE Sensorineural hearing loss called FX 322. However, there have been some new developments in testing the long-term effectiveness of the drug as well as the start of Phase 2a FDA Clinical Trials.
To provide some background, the Drug FX 322 was developed by Frequency Therapeutics as a way of regrowing or regenerating Inner and/or Outer Hair Cells inside of the Cochlea. If successful, it could result in hearing improvement for individuals with Sensorineural Hearing Loss (SNHL), which is the most common form of hearing loss.
During Phase 1a Clinical Trials, FX 322 was proven to be safe to use, and resulted in statistically significant word recognition scores and slight improvements in Hearing Thresholds at 8,000 Hz. This suggests the drug’s ability to restore some Inner and Outer Hair Cell function with a single dose injected through the eardrum onto the Round Window of the Cochlea. This has created a lot of excitement in the Hard of Hearing Community because of the potential promise of restoring the natural function of the Cochlea.
So what has Frequency Therapeutics been up to since the completion of the Phase 1a Clinical Trials? First, they retested the original subjects from the first clinical trials, 13-21 months after the completion, to see if they maintained improvement. They identified that 4 of the 5 maintained the benefit of FX 322, and 3 of those 4 has statistically significant improvement. This suggests that even with a single dose of FX 322, individuals were able to maintain their level of improvement for up to 21 months.
The Phase 2a clinic trial recruitment of 95 subjects was also completed. This is expected to take a total of 7 months to complete with the final subject expected to complete the trial sometime in April of 2021.
The subjects will be placed into one of four groups:
Group 1: 1 dose of FX 322 & 3 Placebo doses
Group 2: 2 doses of FX 322 & 2 Placebo doses
Group 3: 4 doses of FX 322 & No Placebo doses
Group 4 (control group): No doses of FX 322 & No Placebo doses
Each group will receive 1 injection, 1 week apart and will be monitored for 6 months following the completion of dosing. This will allow Frequency therapeutics to identify if increased dosage has a larger impact on restoring cochlear function.
Frequency therapeutics will also be using Standardized Outcome Questionnaires to determine if there is subjective improvement using the Hearing Handicap Inventory for Adults (HHIA) and the Tinnitus Functional Index (TFI). If positive results are achieved during Phase 2a Clinical Trials, expect Frequency Therapeutics to apply for “Breakthrough Designation” from the FDA which could speed-up round 3 of Clinical Trials.
Overall, this is pretty exciting news for individuals with hearing loss and give promise that we could see a therapeutic drug treatment for sensorineural hearing loss in the next decade. Of course, until that time arrives for individuals with sensorineural hearing loss (SNHL), the best thing you can do is to utilize hearing aid technology to stimulate the auditory centers of your brain. Not only will this help you communicate better now, it may even lead to a more positive outcome if/when FX 322 becomes available.