Frequency Therapeutics — Hearing Loss Regeneration
- Thread starter RB2014
- Start date
This drug is not about regeneration. It's about protecting your hair cells before they become damaged.
It's for acute cases (less than 96 hours). It prevents permanent damage, it does not regrow hair cells. Probably not relevant for anyone on this forum, unfortunately.
Although, could be good for re-injuries or subsequent noise exposure if used right away.
MemberIf you look at the "actual study completion date" for STR001 it was Feb 6th. That predates the current state of affairs with the coronavirus. Fauci is saying we could see millions of US infections and 200k deaths. So I don't think we've seen the worst of the situation yet.
It's great news but I'm not sure this drug will work at all for chronic hearing loss. It looks to be intended for sudden sensorineural hearing loss (SSNHL), rescuing acutely damaged structures in the cochlea before they die. Not regrowing brand new hair cells like FX-322.
Strekin drug will only have use for those who have significant hearing loss from noise trauma all at once or SSHL, because nobody with sustained minor damage that eventually leads to problems will go to the emergency room go get the Strekin drug. Hell, most new to tinnitus don't get prednisone within 48-96 hours after trauma before cell apoptosis starts.
- Dec 21, 2019
- 319
- Tinnitus Since
- 2014, 10/2019
- Cause of Tinnitus
- School Band, Noxious Car Radio
Saying the Strekin drug regenerates hair cells is like saying fire extinguishers reconstruct burnt buildings. It's a different class of drug, still wonderful to have it added to the arsenal of medical professionals though!
My impression is that the Strekin drug is prednisone that really does work, where with prednisone we're still at "might work, might do nothing, might give you nasty side effects." Just by its existence it might help classifying acoustic traumas more as an emergency because there is meaning in treating it as an emergency (no need if you probably can't really do anything about it). I'm curious about the upcoming results of the phase 3 trial.
Frequency Therapeutics updated the slides to their corporate presentation. One meaningful change I noticed is on slide 15. The diagram now shows the concentration of FX-322 only reaching shy of 6000Hz, whereas before, this same diagram illustrated it as reaching past 4000Hz.
Source:
https://investors.frequencytx.com/static-files/6d161090-16f5-49f4-9606-8caceb5a88a1
Source:
https://investors.frequencytx.com/static-files/6d161090-16f5-49f4-9606-8caceb5a88a1
The wording is also different on that slide. They said "highest concentration" and showed above 6000Hz. Previously they said "effective concentrations" over 3500Hz or something to that effect.
I think they should be asked about the distinction and why it was changed.
- Dec 21, 2019
- 319
- Tinnitus Since
- 2014, 10/2019
- Cause of Tinnitus
- School Band, Noxious Car Radio
I agree! That is how I understand it as well. An effective drug to stop apoptosis in the cochlea is very exciting. I would have loved to have an option like this when I had my acoustic trauma, I didn't even get offered prednisone.
So, this thread has been going for 257 pages now and I don't really have the time to go through it all, so I just want to ask:
With what we currently know, does it seem that FX-322 is worth it?
Asking because they're doing trials in my city and I could be eligible to take part.
A part of me wants to do it. Even if I don't get better, I'd end up being a small part of medical history which is pretty cool, and I could get some money for participating.
But another part of me feels that it's not worth the risk. The examinations include tympanometries, which many people on this site have had bad luck with. This assuming that I get the drug and not the placebo.
Should I risk it?
With what we currently know, does it seem that FX-322 is worth it?
Asking because they're doing trials in my city and I could be eligible to take part.
A part of me wants to do it. Even if I don't get better, I'd end up being a small part of medical history which is pretty cool, and I could get some money for participating.
But another part of me feels that it's not worth the risk. The examinations include tympanometries, which many people on this site have had bad luck with. This assuming that I get the drug and not the placebo.
Should I risk it?
- Feb 14, 2020
- 1,630
- Tinnitus Since
- 1-2019
- Cause of Tinnitus
- 20+ Years of Live Music, Motorcycles, and Power Tools
I noticed that as well. They also fixed the location of the "Hz" labels on the cochlea. It's probably that they want the presentation to represent the Phase 1/2 findings as accurately as possible. The SEC interprets these presentations as 'advertising,' so an honest effort has to be made to be accurate, factual, and transparent; without too much promissory language or speculation.
It may be that the designer of the presentation didn't know, or there was some optimistic usage of the gradient. Or perhaps the reviewer was optimistic.
If future data shows that the drug reaches further into the cochlea, it will be revised.
I'll explain myself a bit more, we are actually a step forward in adding this coating layer in the cochlea in order to trick the brain that the hair cells still there and are intact, so tinnitus would stop.
Using your example, like spraying foam extinguisher to that burnt building and then the only thing we could see is the extinguisher foam, thinking the building still intact. That could be the trick...
I don't see how it could if the study was really quadruple blinded as it is still ongoing.
That's a super good point that I hope doesn't get lost in this thread. Per SEC rules, you can't advertise anticipated results as fact (even if you expect them to be) so it would have to show *only* information already established by prior results.
No one can answer that but you.
I tried to get in the trial but was rejected so I clearly believe in the drug. I'm suffering a lot though so, to me, it was a no-brainer but my hearing issues are not noise induced so I wasn't as worried about the noisiness of the testing. There is no wrong answer. Do what you feel is right for you.
Unless I misunderstood what you were saying, Strekin's drug is an anti-oxidant that prevents inflammation from causing permanent damage. It's not a coating that modifies brain perception of hair cells.
Is it the one that's out in the market now or the one that's in the study? I contacted them and got an answer saying that one device is out. Which one do you mean?
I agree, if we can ask about this in the upcoming Tinnitus Talk Podcast with Frequency Therapeutics that would be amazing.
I might be reaching here, but they put labels at the bottom of the slide directly referring to Phase I/II studies, so based on the results we observed, this is consistent through the lens of Phase I/II.
It's still disheartening to see this though. I haven't been around this thread for a while, but I hope there's a question in the list for the interviewers to ask about how far in terms of kHz a maximum therapeutic dose of FX-322 can reach.
What are your thoughts on this slide?
My audiologist said I have a normal audiogram. If I don't have hearing loss then would this help me?
- Sep 21, 2016
- 1,051
- Tinnitus Since
- 2011 - T, 2016- H, relapsed 2019
- Cause of Tinnitus
- noise-induced
The lower the Hz number, the farther the drug has to travel. In the example above, 3500Hz is a considerably longer distance FX-322 has to go to reach than 6000Hz.
The updated slide is a bad thing as it stands now, but more clarity on the information is needed to provide better context.
- Dec 21, 2019
- 319
- Tinnitus Since
- 2014, 10/2019
- Cause of Tinnitus
- School Band, Noxious Car Radio
That is a very personal decision. There are some risks to transtympanic injection, but I don't think severe complications are common. If you go over to the center they will run over risks with you. As far as tympanometry goes, I have personally had it performed twice with no apparent effect. Others have had life altering consequences. Also, if you partake you will pretty much be barred from using Tinnitus Talk, as it's (almost) entirely dedicated to discussing our symptoms.
As far as "does it work?" goes, FX-322 looks very promising (seemingly does what it claims) and has been reported to be safe.
Matters of health like this are best made by yourself and not internet strangers. Have you considered writing out a pros and cons list to decide if its worth it for you?
No one really knows if FX-322 is worth it.
All 257 (now 258!) pages of this thread are speculation.
We just don't know yet, so it's impossible for any of us to evaluate the risk from your perspective.
That said, the drug has generated a lot of enthusiasm, there's an impressive team behind it, they've raised buckets of money, and it's passed phase I safety trials. So if it were me, yes please, I would enroll in the trial.
My thoughts are similar to what @Diesel alluded to. This seems like an SEC thing rather than new clinical information as the trial is still ongoing.
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