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Frequency Therapeutics — Hearing Loss Regeneration
- Thread starter RB2014
- Start date
MemberIf an effective treatment for tinnitus ever emerges, the entire world will know about it in very short order. It will be all over the 10 o'clock news.
The medical profession will be full of it.
In the meantime I'll avoid all the furore, and the unnecessary excitement - I do so hate wetting my pants - and carry on just as before.
I'll get excited when there is some evidence based proof of successful results.
I'm a pragmatist.
Jazzer
The medical profession will be full of it.
In the meantime I'll avoid all the furore, and the unnecessary excitement - I do so hate wetting my pants - and carry on just as before.
I'll get excited when there is some evidence based proof of successful results.
I'm a pragmatist.
Jazzer
- Aug 5, 2019
- 1,852
- Tinnitus Since
- 05/2019
- Cause of Tinnitus
- Autoimmune hyperacusis from Sjogren's Syndrome
Regarding trial design, I'm really curious if anyone has any good rebuttals to my bear thesis on the game theory from the perspective of the "cheater." I think I make pretty good arguments as to (a) why the cheating wouldn't help the placebo group more and (b) in the cases where it does, it's a bad reflection of the drug.
No one said it would help the placebo group *more* unless i missed something. It would just explain why some cheaters got placebo but actually improved.
Both the inconsistencies and the multi dose dampening effect have to be true to explain the results.
The way I understood the results is as follows:
All groups improved wordscores, even placebo groups (bc cheaters) but all drug groups had a dampening effect as well. The individual data would help with this.
Hey, I just came by after the Phase 2a results to say I told you so, but I really had no idea.
Listening to interviews with medical researchers, scientists, doctors, etc... does nothing for me.
Hearing about the 'nitty-gritty' of their research programme does nothing to ease the experience of tinnitus.
Yes - of course I am pleased that research goes on because we clearly need a treatment, but as yet there is no prize to report on, or get excited about.
I don't need a detailed report on what the mechanic intends to do to try to fix my car.
Just let me know when the bloody thing is going again.
Hearing about the 'nitty-gritty' of their research programme does nothing to ease the experience of tinnitus.
Yes - of course I am pleased that research goes on because we clearly need a treatment, but as yet there is no prize to report on, or get excited about.
I don't need a detailed report on what the mechanic intends to do to try to fix my car.
Just let me know when the bloody thing is going again.
- Apr 15, 2017
- 1,419
- Tinnitus Since
- 2008
- Cause of Tinnitus
- Noise
Buying biotech stock is supporting research. Without the investors on board taking the huge risks, research wouldn't advance and clinical trials wouldn't happen. Biotechs have a high failure rate.
I do both. So do many members here who hold stock and contribute to this community. The members here who invest their time supporting others and discussing research are investing their time here.
The people on stock boards looking to just to make cash probably have little interest, apart from financial motivation, for it to succeed. That's what makes the world go round after all.
Even though I lost most of my investment and pulled out as I have lost confidence in FREQ, I still contribute to Tinnitus Talk and will continue to do so as I can afford it.
Everybody who uses Tinnitus Talk especially for the discussion of research should be contributing if they can afford to do so. It also beats sending money to a charity that I have no idea what they do with it; or who in the past have been promoting shit like TRT.
ajc
Member
- Feb 6, 2018
- 1,170
- Tinnitus Since
- 11/2002; spike 2009; worse 2017-18
- Cause of Tinnitus
- Loud music - noise damage
I'm curious why you post in this thread then. You've now said twice in 24 hours how this doesn't interest you, everyone knows it now. Others here, in the meanwhile, want to stay informed about research. To each his own.
Keith Handy
Member
- Jan 5, 2021
- 302
- Tinnitus Since
- 11/2020
- Cause of Tinnitus
- Stress + sleep deprivation + noise
Question: do any of the ongoing single-dose trials have EHF audiograms as an experimental outcome? I'd like to see that given another shot (no pun intended) without the apparently detrimental multi-dosing effect.
Yes, both ongoing studies got them as Secondary Outcome Measure. Point No. 4.
Adults With Severe SHL:
https://www.clinicaltrials.gov/ct2/show/NCT04629664
Adults With Age-Related SHL:
https://www.clinicaltrials.gov/ct2/show/NCT04601909
Keith Handy
Member
- Jan 5, 2021
- 302
- Tinnitus Since
- 11/2020
- Cause of Tinnitus
- Stress + sleep deprivation + noise
OK, good to know that (and TFI) will continue to be looked at in ongoing and presumably forthcoming trials. The Phase 2a report was so discouraging that I feel like it can only get a little better from here. I wish all of us some comfort and maybe some reasonably modest life improvements in the meantime, as we wait for science to do its glacially-paced work.
Because they already saw improvements in WR and Audimetry by day 90 from previous Phase 1/2 study.
Because they are primarily safety studies in new treatment populations with some measures that could be used to evaluate safety and efficacy.
Phase 2a was the efficacy trial. A redo of Phase 2 would be a longer monitoring period with different trial design and dosing. So if tinnitus takes time, that wouldn't be known before that point unless they go back later and interview Phase 1b participants.
Keith Handy
Member
- Jan 5, 2021
- 302
- Tinnitus Since
- 11/2020
- Cause of Tinnitus
- Stress + sleep deprivation + noise
Maybe they will report it as "long term follow up" separate from the trial like they did with the Phase 1 results.
Firstly, buying biotech stock is support only if you take part in IPO or during capital raise. If you buy FREQ after that, it is not support at all.
Secondly, I appreciate the time and effort of many people here. But unfortunately, it doesn't bring diagnostics or treatments much closer. More action is needed.
Can you show me where I talked about a charity? I also don't send money to them because if they sponsor things like CBT, then I can throw money out of the window and the effect will be the same.
There was a very interesting Tinnitus Talk Podcast episode in February with Dr. Shoushtarian from the Bionics Institute. She mentioned several times that progress is subject to financing. Meanwhile, their donation page looks like this:
No need to mention that some people here lost more than $100,000 USD by their investment in FREQ. Money that could help tinnitus research was successfully wasted. Congratulations :-(
- Feb 14, 2020
- 1,630
- Tinnitus Since
- 1-2019
- Cause of Tinnitus
- 20+ Years of Live Music, Motorcycles, and Power Tools
Err... not exactly. And you should know this if you're commenting on it.
Several different financial activities can take place to fund the firm depending on stock price / market cap / shares outstanding. Including:
- The issuing of a new shelf of shares to raise capital to extend the business at the new higher market price. Yes, it dilutes the current shareholder, but this isn't favorable if the stock is too cheap, underbought, or below IPO.
- The sale of retained shares by the company to raise cash. Frequency Therapeutics owns a certain amount of its own shares when they are issued in the IPO.
- Raising debt capital. Currently, the firm has $0 in debt (because they have a TON of cash), but could leverage it if needed.
- Utilizing retained shares to make acquisitions. IE: Issue FREQ shares to some revolutionary delivery company stakeholders in order to acquire their method.
- Ability to resist a takeover. (Which would SLOW progress on FX-322 wayy down). When the stock price put them at a cap of about $1.5B, takeover was not likely. Now that they're hovering around a third of that, the risk is higher.
Frequency Therapeutics Releases New Data from Two FX-322 Clinical Studies; Plans to Advance Single-Dose Regimen
"At day 90 following dosing, thirty-four percent (34%) of subjects achieved a ten percent (10%) or greater absolute improvement in WR scores in the treated ear, which was clinically meaningful and statistically significant compared to the untreated ear (p <0.05) ... This included a subset of subjects that more than doubled their WR scores."
10% "or more".
Some patients have "doubled".
On page 17 of the next presentation, it says "Exceeding Absolute 10%".
Perhaps the criteria they consider to be "statistically significant" is 10% or more and below.
Also, if you read page 16 carefully, you will see that the nuances are a little different.
Page 17 is about Phase 1b-111 and page 16 is about Phase 2a.
https://investors.frequencytx.com/static-files/4a540e6b-b160-4e35-b487-5c82d264103b
• FX-322 continues to have a favorable safety profile
(• No treatment related SAEs reported)
(• Comparable AEs in placebo and FX-322 groups)
• Treatment regimen using four weekly injections was unfavorable
(• Creates an environment within the ear diminishing ability to effectively demonstrate hearing signal)
• Study design led to hearing increases in placebo group that exceed our other studies and published standards
(• Requiring subjects to have a word recognition deficit suppressed scores at baseline (pre-treatment)
• No discernible hearing improvement over placebo observed
(• "Incidence higher across all groups than in single dose studies")
• Company plans to advance single injection regimen moving forward
(• Developing plans to mitigate bias in future studies)
So far, these are their official announcements.
tarmaced
Member
- Mar 23, 2019
- 79
- Tinnitus Since
- 2004 (mild) 2018 (not so mild)
- Cause of Tinnitus
- Ear infections, compounded by noise exposure
So the incidence rate of 10% or more improvement rose with multiple doses?
Although the rate of larger scale gains decreased?
Or am I wrong?
I suppose the subjects that more than doubled their WR score will be the same who faked their WR score in recruitment the most.
- Aug 5, 2019
- 1,852
- Tinnitus Since
- 05/2019
- Cause of Tinnitus
- Autoimmune hyperacusis from Sjogren's Syndrome
I must say, I find it surprising that they say this (attached) so boldly.
That's an awful lot of confidence without individual data.
I'm starting to get kind of irritated at the notion that this problem is unique to Frequency Therapeutics. Literally every placebo-controlled medical study has the same basis:
- A problem is being treated that is inherently challenging to have objective measures for
- Person wants to get into the study in order to have a chance at early treatment
- The participants have a bias to be the best to show off the drug
I get what you are saying but there is something very unique about this trial that I feel not enough weight is put on it.
A person with low word scores but who has below severe audiogram changes is a very unusual patient.
They are selecting from a low pool of genuine patients.
And in doing so, selection pressure *greatly* favors the word score depressors in Phase 2a, where it was a requirement.
This greatly affects the degree in which this kind of skews results.
I should add @Zugzug that social media plays a role and there likely have been way more "trial design failures" in recent years based on this but, in particular, when an extremely narrow patient is recruited.
- Aug 5, 2019
- 1,852
- Tinnitus Since
- 05/2019
- Cause of Tinnitus
- Autoimmune hyperacusis from Sjogren's Syndrome
I get what you're saying about genuine challenges in obtaining this specific patient class.
But here's why I still don't feel sympathetic. I would think if recruiting was so difficult (and we can now assume it was), they would prioritize clarity over PTA. In other words, just give up on this perfect patient. Just grab someone with IHC loss who probably has OHC loss (like the severe trial).
Now, of course, if the severe trial is a flop, I'll play Monday morning quarterback and change positions, saying something like "You thought the first hearing regeneration drug would work on people with the worst hearing loss?!?"
I'm just so confused. The only out I can give them is that they are working against investors that aren't sympathetic to these recruiting nuances and just want to see audiogram gains.
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