Frequency Therapeutics — Hearing Loss Regeneration

I clearly see that hope has moved from Lenire to FX-322...

But, is there any proof or data that really shows FX-322 would be effective on long lasting tinnitus and not only on hearing loss?

Hearing loss (or hidden hearing loss) is probably the major factor behind tinnitus but can't it be that once the tinnitus is old and deeply registered into your brain, even restoring hearing loss will not make the tinnitus go away?
 
I clearly see that hope has moved from Lenire to FX-322...

But, is there any proof or data that really shows FX-322 would be effective on long lasting tinnitus and not only on hearing loss?

Hearing loss (or hidden hearing loss) is probably the major factor behind tinnitus but can't it be that once the tinnitus is old and deeply registered into your brain, even restoring hearing loss will not make the tinnitus go away?
Carl LeBel said that ENTs have said unprovoked that people in the trials saw a reduction in their tinnitus.
 
I find it hard to believe the brain would somehow 'remember' the tinnitus. It's a symptom of something, not a thing on its own - usually it's a symptom of hearing loss or damage. In theory that means fixing the damage means the tinnitus should go away.

This is already evident in cases of blockages being resolved and hearing aids helping people. Besides, there's a lot of stories of people who had tinnitus for years and it still went away.
 
Carl LeBel said that ENTs have said unprovoked that people in the trials saw a reduction in their tinnitus.
He made it quite clear that tinnitus sufferers are a group he wants (and expects) FX-322 to help. Hopefully that will translate into more dedicated trials that actually "quantitate" (his wording) improvement.
 
Carl LeBel said that ENTs have said unprovoked that people in the trials saw a reduction in their tinnitus.
Exactly, it wasn't part of the phase 1 trial but the patient testimonials for tinnitus were at least compelling enough for the ENTs to mention this to Frequency Therapeutics as Dr. LeBel alluded to in the Tinnitus Talk Podcast.

Also, @Darktale, if you look at cochlear implant tinnitus studies (which are crude in terms of sound quality and do not treat all frequencies but even they have an effect on a good percentage of people), you can see that the "tinnitus is stuck in the brain" theory is nonsense.

Not to mention Meniere's,where the tinnitus fluctuates with the underlying cochlear pathology (hydrops) until the end stage when hair cells are destroyed. Or any of the other treatable causes of tinnitus (e.g.. TMJ).

To think it's "stuck in the brain" is to think neuroplasticity only works one way, which it doesn't. If you restore normal input, the brain will readjust to the restored input. It's not a switch stuck in one position, that wouldn't make biological sense because it would imply the brain prefers tinnitus and the brain doesn't have those kinds of preferences.
 
I clearly see that hope has moved from Lenire to FX-322...

But, is there any proof or data that really shows FX-322 would be effective on long lasting tinnitus and not only on hearing loss?

Hearing loss (or hidden hearing loss) is probably the major factor behind tinnitus but can't it be that once the tinnitus is old and deeply registered into your brain, even restoring hearing loss will not make the tinnitus go away?
I don't think there would be a 'time limit' on neuroplasticity where tinnitus would fail to resolve even if it's been long-standing. If you fix the underlying pathology of hearing loss then the tinnitus should improve along with it.

@FGG is well-versed on these kinds of questions. Interestingly, I came across a paper on neuroplasticity with regards to pain and it gives the example of osteoarthritis patients experiencing relief with hip replacement, no matter how long the pain has persisted. Perhaps that's slightly different but that to me suggests that 'phantom pains' like tinnitus wouldn't become irreversibly ingrained after a certain time period and would potentially improve upon restoring input.

https://www.mja.com.au/journal/2013/198/4/neuroplasticity-and-pain-what-does-it-all-mean
 
The strategy is... let's not say or do anything that will get our fragile, cash-strapped, negative-profit-producing, single-drug, high-risk company fined to death by the SEC and sued into an early grave by our stockholders / investors.
I absolute agree with this comment. It is obviously as clear as day to anyone that this is exactly what we shall keep seeing from Frequency both with FX-322 and their other projects like MS etc that are inevitably going to be developed.

I think that there are many times where Frequency Therapeutics will say something in either an indirect or also a very cryptic manner. Therefore they are giving us information in regards to their operations, however indirectly so they avoid trouble.
What frustrates me is that FX-322 will be more safer than a COVID-19 vaccine but it will take FX-322 longer to come out. This is not fair at all. There will most likely be more side effects with a COVID-19 vaccine than a FX-322 shot.

FX-322 has already shown to be safe and effective with no side effects. I just want them to release it now.
The reality is that the treatments for both COVID-19 and FX-322 are actually still required to go through the same trial procedures anyway. I agree that we will all want this to come out sooner, however I feel that the delay is necessary to ensure the robustness of FX-322. Furthermore I feel that this will actually be beneficial in terms of treatment.
A lot to unpack here.

First of all, the release of FX-322 has already been delayed because of COVID-19. The phase 2a data was supposed to be released next month and is now being released next year, so it's not BS, that's one hell of a delay. If they were to skip phase 3, the drug would probably be coming early next year if not for COVID-19. It has delayed things and it can delay them again.

Second of all, the US economy is not rebounding. Our unemployment rate is still higher than during the Great Recession, millions are at risk of eviction, millions of people are food insecure and millions have lost their health insurance. Just because the wealthy are doing well does not mean the economy is doing well.

That all said, I'm very optimistic for FX-322 and personally believe we'll see it by 2022. That doesn't mean COVID-19 wasn't very unhelpful in this process and nothing I said was BS. I agree though that help is on the way!
The economic evaluation is fair, however the other aspect that needs to be considered is that the economy is also artificially worsened in multiple areas by COVID-19. Currently many businesses have had to shut down until this passes and as a result there is a flow-on effect which will reduce economic performance in other areas of the economy. For example in my home country travel to other states is currently banned, meaning the tourism sector is essentially non existent. Then there's the shutdowns on businesses which mean people cannot do things like going to the movies or dining in at restaurants.

While we are not seeing signs that the economy might rebound in the short term, there is likely to be a fairly positive and quick upturn post COVID-19 crisis. This is because all those activities which people cannot do now will be allowed to recommence. This will mean more people can work and will also mean more people can therefore now spend on other stuff as well. There are a whole heap of people here receiving government income who won't even spend that at the moment. This is due to them being limited in what they can spend on and also not needing to spend on regular stuff like gas because you can't go anywhere more than 5 kilometers or 3 miles from your residence.

We know that this recovery is going to be highly contingent on a vaccine being produced. However the fact that firms are now up to conducting the trials where people get injected with the vaccine and then the COVID-19 virus is indicative of the fact that there could be something available in 6 months if this is successful. It seems, to date, that there are actually multiple positive vaccines and thus I can see them being released rather rapidly if they will work.

I also agree (and know) that the FX-322 trial's delay is a result of COVID-19. However, I also am aware that there have been other trials delayed by similar numbers of months too. Thus I don't think that this delay is neither significant nor major.
I clearly see that hope has moved from Lenire to FX-322...

But, is there any proof or data that really shows FX-322 would be effective on long lasting tinnitus and not only on hearing loss?

Hearing loss (or hidden hearing loss) is probably the major factor behind tinnitus but can't it be that once the tinnitus is old and deeply registered into your brain, even restoring hearing loss will not make the tinnitus go away?
Reduction of tinnitus is highly likely looking at the information obtained to date. I do think that it will be interesting if work is done to determine the effects of very high frequency hearing recovery on tinnitus.
Yes. Frequency Therapeutics was offered this information from the ENTs without it being part of the study.
I was well aware of those reports and thought that this is what he meant. I just wanted to clarify that this is what the poster actually was referring to by using the adjective unprovoked :D.
 
A lot to unpack here.

First of all, the release of FX-322 has already been delayed because of COVID-19. The phase 2a data was supposed to be released next month and is now being released next year, so it's not BS, that's one hell of a delay. If they were to skip phase 3, the drug would probably be coming early next year if not for COVID-19. It has delayed things and it can delay them again.

Second of all, the US economy is not rebounding. Our unemployment rate is still higher than during the Great Recession, millions are at risk of eviction, millions of people are food insecure and millions have lost their health insurance. Just because the wealthy are doing well does not mean the economy is doing well.

That all said, I'm very optimistic for FX-322 and personally believe we'll see it by 2022. That doesn't mean COVID-19 wasn't very unhelpful in this process and nothing I said was BS. I agree though that help is on the way!
It is my understanding that September 30, 2020 is the estimated study completion date and primary completion date, whereas the last participant in the clinical trial is examined or treated before the data compilation begins.

"The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "estimated" study completion date is the date that the researchers think will be the study completion date."​

As well, the primary completion date for Phase 2a is also September 30, 2020 and is as follows.

"The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "estimated" primary completion date is the date that the researchers think will be the primary completion date for the study."​

This date has never changed despite COVID-19 and Frequency Therapeutics has indicated that the Phase 2a completion date will be early October. The presentation of this data for Phase 2a will come after the results are studied thoroughly in order to reach a valid conclusion of the effectiveness of FX-322 in regard to the 96 participants. This presentation of data is next Spring of 2021.
 
I don't see a big difference between hearing aids and FX-322. Both relieve tinnitus by improving hearing. The people who had an improvement in tinnitus with FX-322, it's unclear whether they experience the same type of improvement as one would with hearing aids.
 
I don't see a big difference between hearing aids and FX-322. Both relieve tinnitus by improving hearing. The people who had an improvement in tinnitus with FX-322, it's unclear whether they experience the same type of improvement as one would with hearing aids.
Hearing aids just amplify sound, they don't improve hearing otherwise. Without going into the details, there is much more to hearing than loudness though improving loudness does help.
 
Hearing aids just amplify sound, they don't improve hearing otherwise. Without going into the details, there is much more to hearing than loudness though improving loudness does help.
Hey so I'm too drunk to answer right now, but, is the comment from @Billy_Shears to me accurate? I thought they said, before COVID-19, that we were supposed to get data this September?

Also I just wanted to say, I really enjoy reading your comments. You are very smart.
 
I thought they said, before COVID-19, that we were supposed to get data this September?
They're still recruiting. LeBel gave out the number to ring just a few days ago, which implies to me that there are quite a few places to fill. They've been recruiting for a long time now, so it's not a quick process. It's 210 days from the date the last participant gets their first injection to when all the data is in. Then they compile it, analyse it, ring their brokers (joking), make graphs, and decide at length what they say and do next. Then we might get top-line results.

September this year is just not going to happen.
 
Hey so I'm too drunk to answer right now, but, is the comment from @Billy_Shears to me accurate? I thought they said, before COVID-19, that we were supposed to get data this September?

Also I just wanted to say, I really enjoy reading your comments. You are very smart.
Hey, thanks :).

Unfortunately, yes, there is a delay. They have said more recently they expect to have results in Q2/2021.

The delay does not seem to be solely a data readout delay though as they are still recruiting at the moment.
 
I'm going into my cryogenic chamber until then. Someone come get me when it is Q2/2021.
Add me to that list too. It's a shame how the criteria was really strict in terms of who they would recruit for the FX-322 trials. I feel like they could have filled up 96 participants easily if more people knew about the clinical trials.
 
Add me to that list too. It's a shame how the criteria was really strict in terms of who they would recruit for the FX-322 trials. I feel like they could have filled up 96 participants easily if more people knew about the clinical trials.
Agreed. I applied last week for the trial at their Fresno test site but was rejected as my hearing loss wasn't bad enough (60 dB at 6 kHz and on). I get that they want to test efficacy on the worst cases but still...
 
Agreed. I applied last week for the trial at their Fresno test site but was rejected as my hearing loss wasn't bad enough (60 dB at 6 kHz and on). I get that they want to test efficacy on the worst cases but still...
Was your hearing normal below 6 kHz? One of the parameters is pure tone average so if you have excellent hearing in the lower frequencies, this could be a factor in making your average better.

Get an extended audiogram if you haven't already. It may give you more data points to skew the average into their range (you will need 2, six months apart but that could get you into the next trial).
 
Was your hearing normal below 6 kHz? One of the parameters is pure tone average so if you have excellent hearing in the lower frequencies, this could be a factor in making your average better.

Get an extended audiogram if you haven't already. It may give you more data points to skew the average into their range (you will need 2, six months apart but that could get you into the next trial).
My hearing is fine at low frequencies but then dips down starting at 2 kHz. My PTA was around 35 dB which I believe meets their inclusion criteria.

In hindsight, it might be better to wait for the next trial anyways since there's the chance of getting the placebo. I do wonder how long it'll take them to complete recruitment though.
 
The delay does not seem to be solely a data readout delay though as they are still recruiting at the moment.
Hi there - so is this thought to be bad news from a development perspective (independent of timelines)? Is there scope for them to modify a trial mid-trial in order to improve results if they don't look good?
 
Screenshot_20200830-194255_Samsung Internet.jpg
 
But, they could also have received placebo.
1 out of 4 chance of getting all placebo shots. More likely they got at least one shot of FX-322.
The 4 shots that he got might have been placebo. The chances of the drug not doing anything is quite low.
Not all improvements are necessarily qualitative. May only be quantifiable by testing (audiograms, speech-in-noise, etc).
 
Facebook posts like that are exactly why people in trials sign NDAs. Just because probability says he likely got at least one shot does not mean he got at least one shot.

A successful trial will include persons who were successfully treated from the drug and persons unsuccessfully treated from the placebo.
 

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