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.My deafness is in the left ear 4000 Hz, 40 dB.
The tinnitus is also in the left ear.
FX-322 treats frequencines from 8000 Hz upwards.
I'm disappointed.
Is it not possible to increase the concentration of this gel?
Is it possible to quadruple the concentration?
Phase1/2 is 0.05ml, 0.2ml.
The amount of medicine was four times.
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?@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.
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.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.
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.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.
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.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 it's that most tests only go up to 16 kHz, even extended tests.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.
To echo everyone's sentiments here, I also really enjoyed the podcast - it was really well done and thorough
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.
What a fantastic podcast!! I'm very grateful to this site.
Just finished listening to the Tinnitus Talk Podcast. Your input was incisive and really helpful. Thank you.
Just finished the Tinnitus Talk Podcast. It was very well done. It's sad that Carl only had an hour (I could probably have listened for several), but it was nice to hear him offer up to come back after Phase 2a. The interview and analysis was also very good.
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 appreciatedThe interview was excellent. Everyone did a great job with it.
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.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.
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
It could clearly be multiple frequencies. I do have that issue.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.
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!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?
Thanks!!!Thanks very much again. It was well done.
When could FX-322 realistically be available to patients in either the USA or elsewhere?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!
Depends. If they go the compassionate use route, they might have it available for some cases at the start of 2021.When could FX-322 realistically be available to patients in either the USA or elsewhere?
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.When could FX-322 realistically be available to patients in either the USA or elsewhere?
Did you have permanent reduction in your tinnitus from LumoMed or do you think it was temporary or placebo?When could FX-322 realistically be available to patients in either the USA or elsewhere?
Who knows? It could be a high frequency hearing loss or it could be another cause.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.
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.When could FX-322 realistically be available to patients in either the USA or elsewhere?
I bet my tinnitus that the year FX-322 becomes available is 2026.When could FX-322 realistically be available to patients in either the USA or elsewhere?
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?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.
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 (?).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?
Is what you describe as phase 4 a release into the market or is it another trial?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.
Both of those things are two different things.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?
Is XEN-496 the Trobalt reformulation? What phase is that now in?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.
It's Trobalt but with different delivery size suited for children. They expect Phase 3 to start this year.Is XEN-496 the Trobalt reformulation? What phase is that now in?