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FDA Grants Hearing Loss Drug, FX-322, Fast Track Designation

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Biotech startup Frequency Therapeutics today announced9 that dosing has commenced in a Phase 2a clinical study of FX-322, a locally administered investigational drug candidate designed to regenerate auditory hair cells and restore hearing function. The objectives of the Phase 2a study are to further establish the positive hearing signal observed in Frequency’s Phase 1/2 study of FX-322, as well as continue to evaluate safety and define the potential dosing regimen. FX-322 is being developed for the treatment of sensorineural hearing loss (), the most common type of hearing loss.

FDA Grants Hearing Loss Drug, FX-322, Fast Track Designation

FX-322 is a locally administered investigational drug candidate designed to regenerate auditory hair cells and restore hearing function.

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I participated in fx-322 trial. it did improve my tones higher then 4k frequencies so I think its impressive that it actually does help. the only issue is that it didn’t help in lower frequencies where i need help.

now they are starting fx-345 trial which should help in lower frequencies.

Wow. After countless discussions on FX I get to meet an actual participant!

If you don’t mind… Have you kept all your gains? Has it helped you in real life with speech understanding? Tinnitus before or after? Do you know actual numbers? Was this the failed trial with the multiple dosing?

Honestly, lately I’ve been doubting if anyone was really helped at all, so thanks for letting us know.

Finally someone who participated in the trial!

Could you post your before and after ? Did you get a real improvement in dialogue recognition especially in noisy situations?
Thank you

That’s one way to look at it. Another, is that the graphically depicted information you requested, may not be simple to provide.

very sorry…I did not notice all this response until now. it was 2 years ago and from my email I have my final results only. I have asked team to send me before and after again to me. I will also then ask them if I am authorized to share. but like I said the gains were above 4k range and i think it was 5 to 10 db gain.

@aliakhtar said:

the gains were above 4k range and i think it was 5 to 10 db gain.

Sounds about right. I posed this question back in 2020:

@d_Wooluf said:

Two separate quotes from experts. Which one is right?

A 10-decibel improvement is really a tripling in the ability to hear a tone at that particular pitch,” said Frequency Chief Development Officer Carl LeBel, Ph.D.

An improvement of 10 decibels at 8000 hertz is also almost a negligible gain, adds University of Iowa’s Gantz, “within test, retest variability of an audiogram,” he says.

I think the second one is more accurate. I think the first is talking about energy levels and not perceived loudness.

That was @Neville’s opinion too. It was like the first quote was almost an outlandish thing to say. That’s FX though. The science might be great for all I know but their relentless self-promotion makes me skeptical.

@aliakhtar said:

fx-345 trial

They just started the trial for the newer version (FX-345) in Dec. Supposed to penetrate deeper into the cochlea to address lower frequencies. I’d happily take an extra 10 db across the board.

Jordan

https://www.businesswire.com/news/home/20221215005106/en/Frequency-Therapeutics-Announces-First-Patient-Dosed-in-Phase-1b-Study-of-FX-345-the-Company’s-Second-Therapeutic-Candidate-for-Sensorineural-Hearing-Loss2

In reply to @ssa

@ssa said:

correct, It could be the person having a bad day or a good day that could make a different… 10 db is not going to make a different…

But test-retest variability diminishes in importance with enough trial participants and enough tests per participant, right?

Depends on definition of “importance.” 10dB may be statistically significant, ie a “real,” repeatable difference, but 10dB is still not going to make much difference to somebody with a 90dB loss.

@MDB said:

10dB is still not going to make much difference to somebody with a 90dB loss.

Would you say that someone with an 80dB loss shouldn’t care if they lose another 10dB? That’s logically the same thing.

I don’t know about “not caring,” but I don’t think it’s going to make much difference.

“In general, as reported by biotech news site Evaluate, the FX-322 trial results1 have largely been lackluster. In fact, Bloomberg Law reported in summer 2021 that investors have filed suit against the company for making false claims about the clinical trials.”

Hearing loss drug FX-322 fails to show benefit in clinical trials8

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

I figured this would be the case. They never answered my email asking if they were able to treat profound hearing loss yet and what kind of numbers they achieved. No email answers to a detail request is usually a bad sign.

FX changed gears when the audiometry scores were lacklustre. It’s all about word recognition scores now. I haven’t seen an explanation that makes sense to me why minimal changes in thresholds would lead to significant improvement in ‘clarity’. If I were going to have someone inject something into my ear, I’d like to think that they knew why.

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