Frequency Therapeutics — Hearing Loss Regeneration
- Thread starter RB2014
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Street Novelist
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- Apr 2, 2018
- 290
- Tinnitus Since
- February 2018
- Cause of Tinnitus
- Listening to loud music through headphones
I wish people would stop saying this. It's not going to take years. Frequency Therapeutics is moving very fast, tacking on another trial which is running concurrently with this one.
I can't see Frequency Therapeutics slowing down things if the trials turn out successful. Seems that they are very keen to progress through the trials in the most effective but quickest manner they are able to.
Not to mention that other companies like Otonomy are also actually proceeding with their trials totally fast as well. We can see that this tends to be a sign that they not only want to provide treatments quickly but also help people quickly. At this stage I think that all these companies know they can obtain Breakthrough Therapy status, I think that the real win is that they want to proceed pretty promptly getting treatments out.
It is interesting that FX-322 clinical trial Phase 1b-112 and 113, which adds a much broader range of individuals to the study, is being rather condensed in an expeditious manner. Conceivably in doing so, it lessens the appeal or need of continuing with a lengthy, full-blown Phase III clinical trial.
Unlike most other pharmaceutical and cellular clinical trials , FX-322 methodology inscribes itself only within the tiny world of the human ear with virtually zero effects on the physiology of the body as a whole. FX-322 has sent researchers a signal that in and of itself indicates a precious breakthrough in restoring clarity and normal hearing which could also eradicate tinnitus in many individuals.
My heart wants to believe that FX-322 means March, 2022 - introduction to world markets, and perhaps it is true it was an original goal on their behalf to aim for. Yet, in reality, the conclusive study from Frequency Therapeutics should begin to pay off sometime in 2023, in my opinion. That is still good news.
I agree that in an ideal world it would be 2022, but 2023 would still be a big win.
TrevorSanders
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- Oct 8, 2020
- 85
- Tinnitus Since
- 09/2020
- Cause of Tinnitus
- Noise Exposure/Ototoxic Medication
Why would they reformulate a drug that works? And the current trials underway use varying doses.
Just to make it more potent. So that it works stronger / quicker / lasts longer in the cochlea to reach more frequencies.
TrevorSanders
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- Oct 8, 2020
- 85
- Tinnitus Since
- 09/2020
- Cause of Tinnitus
- Noise Exposure/Ototoxic Medication
I'd assume they'd release the regular formula to the market first and then tweak it later on.
The below quote is what is much more likely to happen.
Having FX-322 reformulated now would mean more trials because they are going to need to take the new dose through things like the safety trials first with FDA.
From what we know so far, we don't know whether the current dosing method for FX-322 will work to treat the normal audiogram frequencies (aside from 8000 Hz). Frequency Therapeutics therefore might be waiting to see what the outcome of multiple intratympanic injections are first before being interested in or willing to work with redosing FX-322.
Don't forget that there is still a massive benefit and massive market for FX-322 even if it is only hypothetically say going to treat up to 8000 Hz and therefore it would be beneficial to both Frequency Therapeutics shareholders and those who would want to buy FX-322 to have it released in its current format.
The thing is Frequency Therapeutics is reactionary in the way which it operates with a lot of things (see how they added different testing after phase 1/2) but this is in a way good because they use evidence to determine what action to take next. Thus this tends to suggest that Frequency Therapeutics won't outlay money on funding drug dosing matters until they have actually got proof that the method used now doesn't work effectively enough to treat the whole hearing range. Therefore I think that this might get addressed after the current trials have finished as dosing outcomes using the current dosing method is clearly one of their aims.
It is worth commenting that there's research which states that utilising multiple intratympanic injections is likely to lead to deeper and also better dosing.
This research on the benefits of multiple intratympanic injections is very consistent with Frequency Therapeutics' hypothesis on how FX-322 works when it is injected because:
- FX-322 targets only the hair cells which are busted. Therefore hair cells which are good or not broken won't get touched then.
- FX-322 only gets consumed and used up when it reaches busted hair cells. Consequently this means that each additional dose of FX-322 will theoretically work with lower frequencies. This is because FX-322 won't start treating hair cells until it reaches busted hair cells and should therefore bypass the first lot of newly treated hair cells. This means that each additional dosing of FX-322 should work with lower frequencies each time.
- This process should theoretically continue with every injection until the whole ear has gotten treated. The issue presently unknown is whether this method of multiple intratympanic injections is in fact ineffective for treatment or whether there is something that stops FX-322 from travelling deeper into the ear as it actually should.
- We know at present that there theoretically should not be anything wrong with FX-322 itself as it is proven to work with all frequencies and provide full regrowth in the lab trials.
- Thus this trial will likely indicate to us what potential problems might arise with FX-322 in its current form and also any problems with the dosing techniques.
The thing that we know so far is that one shot is probably not enough to help with all areas.
Yeah you can't reformulate something before it hits the market first, without going into trials again from scratch, but they can release it and then tweak it later on going thru express route.
I think in the future they will have to focus on the delivery process and develop a way to get it deeper into the cochlea. It's not the formula, it's the depth of reaches.
Street Novelist
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- Apr 2, 2018
- 290
- Tinnitus Since
- February 2018
- Cause of Tinnitus
- Listening to loud music through headphones
I don't know why some of you keep saying it's going to take 2-3 years before it hits the market. In 2017 they injected it into people who were receiving cochlear implants to test for side effects. There weren't any.
In 2018 they used 1 injection and placebos on people in San Antonio to see if the drug actually worked. It must have worked because in October 2019 they used 4 injections.
When the results come out in May 2021, the only reason to have a Phase 3 would be to increase the amount of people who get 4 injections as opposed to a placebo. It's not like they would learn anything new.
That's why May 2021 is the big date. When they release the results, then we will truly know if the drug can restore full hearing. Having more trials wouldn't prove anything.
And if the drug works (as we all know it does), that changes everything. There would be no more waiting.
I don't know what is so hard to understand.
Why are some people on this board so pessimistic? 2022? 2023? Get the fuck out of here with that shit.
In 2018 they used 1 injection and placebos on people in San Antonio to see if the drug actually worked. It must have worked because in October 2019 they used 4 injections.
When the results come out in May 2021, the only reason to have a Phase 3 would be to increase the amount of people who get 4 injections as opposed to a placebo. It's not like they would learn anything new.
That's why May 2021 is the big date. When they release the results, then we will truly know if the drug can restore full hearing. Having more trials wouldn't prove anything.
And if the drug works (as we all know it does), that changes everything. There would be no more waiting.
I don't know what is so hard to understand.
Why are some people on this board so pessimistic? 2022? 2023? Get the fuck out of here with that shit.
I don't think 2-3 years is pessimistic, though? It's rather optimistic, actually.
Rather than trying to guesstimate when FX-322 will be released to market, I'm just happy there's a continued stream of positive news.
Most of the ENTs and audiologists I've spoken to don't believe there'll ever be any cure or relief at all, so the fact that FX-322 exists at all gives me a lot of hope.
In the meantime, I'm just trying to cope the best I can. And this thread certainly helps to keep me motivated.
- Feb 14, 2020
- 1,630
- Tinnitus Since
- 1-2019
- Cause of Tinnitus
- 20+ Years of Live Music, Motorcycles, and Power Tools
Frequency Therapeutics dosed their first patient with FX-322 in a clinical trial in 2017. Based on research I shared a few pages back, the average expectation of a drug gaining final FDA approval from first dosing is 9 years.
Which would mean 2026.
FX-332 received Fast Track, which lowers the estimate to 7 years: 2024.
IF Breakthrough Designation, they may get it to 5 years, or 2022.
Based on the plans disclosed thus far by Frequency Therapeutics to end 3 trials in 2021, and speculation that a pivotal trial may take place in 2022; it's likely they are beating the average Fast Track duration, with an FDA approval possible in 2023.
Why a pivotal Phase 2b/3 might be needed for FX-322 in 2022/2023:
- To get approved for mild-severe SNHL/NIHL
- To get approved for Age-Related hearing loss
- Off-label treatment for subjective tinnitus
- Assess side effects of the drug from a wider range of patients. So far, about 150 patients will have been injected with the drug by Q3 2021. That's not enough to gauge significant side effects.
Koz
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- Dec 15, 2013
- 153
- Tinnitus Since
- 2009
- Cause of Tinnitus
- Unilateral sensorineural hearing loss
Does anyone know when the severe hearing loss trial results will be out? It can't be long after May 2021 if they're starting on it now I imagine?
Can you elaborate on express route?
That's because ENTs and audiologists are stuck in the 1990s when Jastreboff reigned.
TrevorSanders
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- Oct 8, 2020
- 85
- Tinnitus Since
- 09/2020
- Cause of Tinnitus
- Noise Exposure/Ototoxic Medication
ENTs don't want a cure. They want you repeatedly coming back to them to line their pockets. A couple of injections brings them in a lot less money than selling you hearing aids and bullshit TRT protocols. Healthy people don't make doctors money.
Michael01
Member
I don't think all ENTs think that way, or I'd hope not. Seeing a lot of the ones I've seen seem to have tinnitus themselves, surely they'd want a cure if only for themselves?
Most/many ENTs and audiologists actually still think that it is not possible to get medicine into the cochlea or you cannot regrow the hair cells consequently which is incredibly indicative of how not up to date they are with what companies are doing. This has already been proven to be possible so it demonstrates their claims are not necessarily accurate. Furthermore a lot of this has got to do with the fact that there has been something worked out which has never been done before so I think some in the industry are being critical for no other reason than maintaining the status quo.
There are actually also some audiologists and ENTs who think that there will be a treatment for this sort of stuff and are interested in it and will want to work with this stuff which is a positive sign. Still this is what gives me a lot of reassurance right now as if the treatments are successful then I hope that those willing to treat this stuff benefit because people flood their place wanting their assistance.
This is partially true though I think the audiologists are actually the ones who don't want these treatments. The thing is that even if hypothetically FX-322 restored only the very high frequencies it is going to mean a big reduction in the type and the volume of hearing aids which could potentially be sold. This is why I think there have been examples of audiologists criticising medicines and also making unsupported or incorrect claims about why the medicine won't work because there are some who simply don't want it to work.
Street Novelist
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- Apr 2, 2018
- 290
- Tinnitus Since
- February 2018
- Cause of Tinnitus
- Listening to loud music through headphones
If they do have a Phase 3 trial, I hope they do it in 2021 and not make us wait a year. I don't know how much more waiting I can do. And I'm sure there are others who feel the same.
I am with you on this. There are three things that we know when it comes to moving forward with the clinical trials:
1. The current phase 1b and phase 2a trials should be done by mid-2021. The results need to be submitted to the FDA and there also is a lag time which the FDA has to respond.
2. Phase 3 trials could theoretically start next year, although it is very dependent on how much ground work Frequency Therapeutics has laid to get this happening. We do know Frequency Therapeutics won't delay the trials though without good reason as it is extremely evident that they are focused on delivering outcomes which will benefit people quickly.
3. COVID-19 has adversely affected the progression of this clinical trial, though only by 6 months. Even though this is agonising, I think it is amazing that we are even this near to a treatment for something that has never been treated before.
I certainly think that Frequency Therapeutics will work hard and get things done quickly. It is very clear that they are fully focused on this and we should have confidence that they are not going to be pedestrians either. Essentially I think the same can be said for most companies within this area as Otonomy is also just as willing to move quickly hence how they want to progress with their tinnitus medicine trials immediately after the FDA allows them to do so.
Waiting is a real pain, however I think that things will get done and it is incredibly clear that these firms want to get things done.
Rubenslash
Member
I created my account here 3 days after this thread was started, it has been a dream since then. Good thing is, when I started reading about hair cell regeneration early 2016, they were still saying it's "decades away", unbelievable the progress that has been made since then.
Koz
Member
- Dec 15, 2013
- 153
- Tinnitus Since
- 2009
- Cause of Tinnitus
- Unilateral sensorineural hearing loss
Forgive me for asking but phase 1b is the FX-322 trial for severe hearing loss, right? I have my eyes on that one now as I'm mostly in the severe range. I hope the efficacy results of that are also out in 2021 and not far from the May one.
I can't seem to find the Clinical Trials page for it, hence why I ask.
Edit: Nevermind, seems like that's age related. I need more info on the severe hearing loss one.
ENTs dont sell hearing aids and TRT protocols - audiologists do.
ENTs dont like the word "tinnitus", they like words like ear infection, tonsils, adenoids, deviated septum, pharynx, larynx stuff like that.
There are actually a few ENTs I have come across who support treatment. There tends to be a few who are playing it very safe though by not saying anything in public because it is incredibly likely that they are going to inflame debate and also actually create rifts with those who they have to work productively with now.
In my country it is really certain that ENTs would jump on this treatment because it is a high return for little effort procedure. I'm pretty positive most people wouldn't whinge about getting to charge $120 to do an injection in the ear and also a small amount of consulting too before they administer the medicine. Most importantly it is illegal for ENTs to get kickbacks for pushing specific hearing aids or sending people to get certain medicines/treatments and as a result I can't see any of this compromising the ability to get treatment.
Koz
Member
- Dec 15, 2013
- 153
- Tinnitus Since
- 2009
- Cause of Tinnitus
- Unilateral sensorineural hearing loss
I'm sorry to keep asking the same question but can someone please answer me?
Where have they stated they are now also looking to test FX-322 on severe hearing loss patients and is that a separate trial to their current one? I can't find any info on this.
Where have they stated they are now also looking to test FX-322 on severe hearing loss patients and is that a separate trial to their current one? I can't find any info on this.