Frequency Therapeutics — Hearing Loss Regeneration
- Thread starter RB2014
- Start date
Pink Noise
Member
- Dec 2, 2019
- 81
- Tinnitus Since
- 09/2019
- Cause of Tinnitus
- Probably headphones (Overear) coupled with age (sigh)
I wonder if treating above 8 kHz will have a side effect of bringing the perception of the lower frequencies up ever so slightly. I have no scientific basis for that though, but I do wonder.
Member- Feb 14, 2020
- 1,630
- Tinnitus Since
- 1-2019
- Cause of Tinnitus
- 20+ Years of Live Music, Motorcycles, and Power Tools
@Hazel, @Markku, @Autumnly, @mrbrightside614, @FGG.
Awesome work on the podcast. The discussion was really helpful and provided insight on many of the ongoing discussions on this thread. Easily one of the most informative interviews I have seen since starting to follow the company.
It is really reassuring to hear of their commitment to helping people with hearing loss quickly.
Looking forward to the next interview with Frequency.
Awesome work on the podcast. The discussion was really helpful and provided insight on many of the ongoing discussions on this thread. Easily one of the most informative interviews I have seen since starting to follow the company.
It is really reassuring to hear of their commitment to helping people with hearing loss quickly.
Looking forward to the next interview with Frequency.
Has a clear indication been given as to when Tinnitus Talk will next interview Frequency Therapeutics, or is it a matter of just whenever the phase 2 trials finish and can be reported back, as I know this might be a bit variable with the delays?
I do wish they were testing a bit higher than 16 kHz as well, like 17 kHz, 18 kHz. Granted, we'll get an idea of what it can do with the audiograms if there's improvement. If someone comes out of the 4 doses hearing 20 kHz, then there's hope that this can help everyone, as it means it spurs the ear to go back to a developmental mode, repairing the previous losses.
At the very least it would make the study of tinnitus easier if it repairs the ear and yet the tinnitus is still present. That would make it clearer that the issue would be either hidden hearing loss, or in the audio circuit itself. Which also has investigations in the pipeline.
At the very least it would make the study of tinnitus easier if it repairs the ear and yet the tinnitus is still present. That would make it clearer that the issue would be either hidden hearing loss, or in the audio circuit itself. Which also has investigations in the pipeline.
Theoretically there's the possibility that they might extend it to this later on, however I would cautiously assume that there is a reason that they test only up to 16 kHz.
- Sep 21, 2016
- 1,051
- Tinnitus Since
- 2011 - T, 2016- H, relapsed 2019
- Cause of Tinnitus
- noise-induced
To echo everyone's sentiments here, I also really enjoyed the podcast - it was really well done and thorough (technically, I read the transcript haha). I particularly appreciated the discussion about how stringently the trials were controlled and the placebo phenomenon etc. The fact that we're seeing results that have never before been seen in human ears is very exciting - I truly think Frequency has cracked this nut. I also liked the more technical discussion of the drug's mechanism of action - to me, Frequency's technique and PCA platform seems very 'elegant' and refined - this really highlighted the advantages of this approach compared to, say, Audion's where your depleting your source of support cells etc.
I found their comments on hidden hearing loss quite intriguing and whether this is more an issue that's found in the extended high frequencies? I'm very heartened at the pace of this work and that they are not ruling out compassionate use once we have further data.
I found their comments on hidden hearing loss quite intriguing and whether this is more an issue that's found in the extended high frequencies? I'm very heartened at the pace of this work and that they are not ruling out compassionate use once we have further data.
- Feb 14, 2020
- 1,630
- Tinnitus Since
- 1-2019
- Cause of Tinnitus
- 20+ Years of Live Music, Motorcycles, and Power Tools
It would stand to reason if gains are seen 8 kHz - 16kHz, gains are present even higher. The other issue is, some people simply are not able to hear much above 16 kHz from a genetic standpoint. They don't have the sensory cells even at birth. The entry point in the round window of the cochlea is adjacent to everyone's highest range of hearing where concentration of FX-332 will be the highest.
It would make the study of tinnitus as a symptom of hearing loss "easier" if those who had their IHC/OHC restored from FX-322 experience a reduction in their tinnitus symptom. Finally, tinnitus researchers could check the hearing loss box, move on from a lot of wasted resources, and focus on treating other causes that FX-322 can't treat.
Also, for those who have tinnitus in ranges below whatever FX-322 can reach, (right now, 8 kHz) it's really a matter of time; and R&D can focus on bolstering the delivery agent.
I think that there is a chance that they will be able to get the drug down further in. I feel that the issue is now that they need to see if they can get it working robustly first and then focus on reforming the delivery method.
I am certain that they neither have any idea if administering more doses has had benefit or not yet either. Furthermore, there is the possibility that part of the drug reformulation process may be a slower dissolve product.
I am just hopeful we will see success and also really reassured that there is good research being done into the performance of the drug. Definitely seems that they will do all they can and as quickly as they can to resolve this.
I think it's that most tests only go up to 16 kHz, even extended tests.
https://www.researchgate.net/public...-young-adult-amateur-musician-recorded-in.ppm
Director- Oct 24, 2017
- 849
- Tinnitus Since
- 10/2017
- Cause of Tinnitus
- one-sided hearing loss (of unknown origin)
Hi there, we just want to thank everyone for their kind responses and compliments about the quality of the podcast. We worked hard, so it's super nice to be appreciated
- Apr 15, 2017
- 1,419
- Tinnitus Since
- 2008
- Cause of Tinnitus
- Noise
You know your hearing loss where it is in the frequency range on an audiogram - that is supposed to be reflected by the kHz you hear in your tinnitus so if you have a 40 dB dip at 8 kHz you'll hear a tinnitus frequency of 8 kHz... What about those with normal audiograms and tinnitus frequencies they struggle to put a kHz on? This has caused concern for me as when I tried DIY ACRN I had no clue what frequencies for it to be around. It varies slightly, hissing, screeching, both, one louder than the other for a few weeks, then the other one might take over...
Anyway, relating to Frequency Therapeutics, I even wonder If people in my situation (normal audiograms yet still have tinnitus) would even be a candidate...
P.S. Two audiograms were normal, but the third one said I had a slight hearing loss in my non tinnitus ear which was bizarre and normal hearing in my tinnitus ear.
I'm just wondering what Frequency Therapeutics' answer to cases similar to mine is.
Also, I am fully aware that is a drug first and foremost for hearing loss and if it turned out to be a tinnitus cure that would just be well, amazing.
Anyway, relating to Frequency Therapeutics, I even wonder If people in my situation (normal audiograms yet still have tinnitus) would even be a candidate...
P.S. Two audiograms were normal, but the third one said I had a slight hearing loss in my non tinnitus ear which was bizarre and normal hearing in my tinnitus ear.
I'm just wondering what Frequency Therapeutics' answer to cases similar to mine is.
Also, I am fully aware that is a drug first and foremost for hearing loss and if it turned out to be a tinnitus cure that would just be well, amazing.
Were these standard or extended audiograms? Lots of people with hearing loss have normal standard audiograms. I would get an extended one if you haven't already.
Do you have any information in regards to when another interview with Frequency Therapeutics might be done? Or is that still up in the air, also due to the fact that the FX-322 trials are a bit all over the place at the moment?Hi there, we just want to thank everyone for their kind responses and compliments about the quality of the podcast. We worked hard, so it's super nice to be appreciated
Thanks very much again. It was well done.
- Jan 17, 2020
- 372
- Tinnitus Since
- 01/2020
- Cause of Tinnitus
- Probably noise, stress and a neck injury.
I'm actually wondering... if your tinnitus isn't a (constant) tone at a certain frequency, what would that mean in terms of hearing loss/damage? Obviously there's some as none of us have avoided it completely, but I cannot match my tinnitus to any frequency because it changes so often and the baseline has no real tonal quality to it. At its lowest it's more of a ''sensation'' of noise.
I expect I do have hearing damage like everyone in the world, but - not having pure tonal tinnitus makes it hard to guess at what frequency it is, and where to expect any hearing damage.
I expect I do have hearing damage like everyone in the world, but - not having pure tonal tinnitus makes it hard to guess at what frequency it is, and where to expect any hearing damage.
- Oct 24, 2017
- 849
- Tinnitus Since
- 10/2017
- Cause of Tinnitus
- one-sided hearing loss (of unknown origin)
No date yet for the follow-up interview, but we plan to get back to them as soon as their Phase 2 results are out!
Thanks!!!
- Apr 23, 2019
- 364
- Tinnitus Since
- 04/2019
- Cause of Tinnitus
- Slap to the ear / Leading to more issues after ear surgery
When could FX-322 realistically be available to patients in either the USA or elsewhere?
Depends. If they go the compassionate use route, they might have it available for some cases at the start of 2021.
Most likely, they're going to limit that, and it would be sometime around 2022 or 2023.
The Tinnitus Talk Podcast interview stated that the possibility of reexamining the idea of a compassionate use allowance (off the table now) actually might get made post phase 2a depending on what happens and what the results are. If so this will mean potentially a year away at a minimum. My understanding is they have a phase 2b trial planned so this will take at least 8 months plus reporting to do. This is based upon the current trial times that were released.
In the other parts of the world we know Europe and Asia/Japan are running trials next year managed by Astellas. This is likely to not only be a requirement before they are allowed to release anyway but also is a payment trigger from Astellas. As since Frequency Therapeutics are a startup company cash is a huge but scarce asset, and those trials are going to be conducted.
So since we don't know what post phase 2 completion means; may mean including the foreign trials I will guess it is going to be early 2022 at a bare minimum.
In Australia (my home) it is possible that they won't need to do a subsequent clinical trial as they consider the results of certain countries' trials as being valid here. So basically when the US releases it after completing the correct amount of trials Australia can do so too.
- Jan 25, 2013
- 3,598
- Tinnitus Since
- 2008
- Cause of Tinnitus
- TMJ disorder, airplane barotrauma, noise exposure.
Did you have permanent reduction in your tinnitus from LumoMed or do you think it was temporary or placebo?
I assume it was unsatisfactory if you are looking at FX-322.
Who knows? It could be a high frequency hearing loss or it could be another cause.
I commenced a new trial today of hearing aids that I have never used and at this stage so far I have barely noticed or had any symptoms of tinnitus whatsoever. I can recognise the higher frequency tinnitus when in a quiet setting but the lower frequency tinnitus has gone away. I would highly assume that the additional audio stimulation has helped me with this thus far.
Hence I would suggest that if your tinnitus is stimulated possibly by a very high frequency hearing loss and if you were to restore this then I would hazard a guess that the increased audio stimulation would eliminate it... I'd dare say that this would be how FX-322 would help you.
- Oct 24, 2017
- 849
- Tinnitus Since
- 10/2017
- Cause of Tinnitus
- one-sided hearing loss (of unknown origin)
No one can really answer this question, folks. Even at Frequency Therapeutics, no one could tell you this (even in confidence), because there are still too many unknowns.
It might be helpful, for those of you not familiar with the drug approval process, to learn more about this. Here's how it's described on the FDA's website. (If you scroll down, you'll see the rough timelines and average success rate per phase.)
FX-322 has currently passed Phase 1, so there's still Phase 2 and Phase 3 left before they can launch the drug (Phase 4 is post-launch). At least, this is what the regular approval process looks like... But as discussed in the podcast, they might (with emphasis on 'might') be able to skip Phase 3 since they got fast track designation. However, even then it will still be at least a couple more years and realistically speaking — if we go by statistical averages — a fair chance of failure still... unfortunately.
UHPTS
Member
- Jan 28, 2020
- 196
- Tinnitus Since
- 10/2019
- Cause of Tinnitus
- Taking drugs on penile fracture
What about Breakthrough Therapy status? If they might be able to skip Phase 3 with Fast Track designation, what does it mean if they get Breakthrough Therapy status as well?
UHPTS
Member
- Jan 28, 2020
- 196
- Tinnitus Since
- 10/2019
- Cause of Tinnitus
- Taking drugs on penile fracture
Based on FDA statistics, the chances that FX-322 will be approved is about 10%. If they are super successful and receive Fast Track status than maybe it could be available in 2023 (?).
My bet for what hits the market in a reasonable time is XEN-496, although it's in a completely different category of drugs and is also very risky due to side effects.
Is what you describe as phase 4 a release into the market or is it another trial?
Alas as always it might fail which I hope it does not. Now having said that there does seem to be a lot of promise from the drug thus far however.
Both of those things are two different things.
I believe Breakthrough Status means that the drug is for a significant condition which no available medication exists. Essentially they have to prove that they have performance results which are statistically significant according to the criteria.
They're nowhere near there yet, however if the positive progress continues and they obtain similar and better outcomes to what they got behind them now then they will surely satisfy this outcome.
UHPTS
Member
- Jan 28, 2020
- 196
- Tinnitus Since
- 10/2019
- Cause of Tinnitus
- Taking drugs on penile fracture
It's Trobalt but with different delivery size suited for children. They expect Phase 3 to start this year.
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