Frequency Therapeutics — Hearing Loss Regeneration
- Thread starter RB2014
- Start date
MemberYou had me laughing about becoming president and abolishing the FDA lmao.My fingers are crossed for the podcast to be out soon & the drug accessible ASAP... c'mon breakthrough status!
I had a dream last night where I became president and abolished the FDA so people that need drugs which are hung up in trials could access them. It may sound extreme but it shows you how deep in my subconscious this stuff has reached...
I feel like drugs such as these should be able to go to an "early market" where you can go ahead and get your dose if you sign a disclaimer or something.
If people are desperate they should be able to try these drugs out as long as they sign a disclaimer form.
No one really knows for sure but some support cell death should still be okay for this drug to work and since FX-322 doesn't deplete them, it won't contribute to support cell death.
A rival company Audion depletes support cells with their method to regrow hair cells.
From what I have read, people with profound hearing loss regardless of the cause are more likely to have bare/dead spots with significant missing support cells. I suspect this might be a reason why Frequency is not being tested on severe to profound loss (but other companies are looking to address severe to profound loss with drugs in pre-clinical and even clinical drugs in the case of Novartis).
You actually can under compassionate/expanded use. See Frequency's website as to their reasons for not doing that at this time.
They plan to be within the speech range, just not the lower part of it with the first formulation.
High frequency is not synonymous with "Ultra high frequency". Don't get confused by the phase 1 results which tested a small amount and single injection.
If you go to their presentations (e.g. Their JP Morgan Presentation and Q and A is a good place to start) on their website, they go into their expected range.
Not sure but my guess would be it depends on the cause. If it's an error in mitochondria for instance (apparently a common cause of genetic deafness), I'm not sure this would help.
Decibel is working specifically on genetic deafness now, however.
You should really take the time to watch their JP Morgan presentation, it's worth it. They have said they look to address over 3500 Hz.
It even addresses your ascertain that the low frequencies are the important frequencies for speech. Speech is more involved than just tracking letters on the speech banana and Frequency are *doubling* word scores in some cases even with their small, safety dose without getting close to those frequencies you mentioned.
Seriously, watch their JP Morgan presentation on their website, and I think a lot of your questions are answered.
- Feb 19, 2020
- 65
- Tinnitus Since
- 11/2017
- Cause of Tinnitus
- Jet Engines, Concert
Speech contains a high percentage of frequencies above 6000 Hz. Interestingly, most hearing aids top at this frequency which makes them limited with understanding speech clarity.
See link below page 17:
https://investors.frequencytx.com/static-files/6d161090-16f5-49f4-9606-8caceb5a88a1
The presentation, just the slides are not very informative. I am going to try to find out more.
Comments on the slides:
There are very few people on this study, only 23 people.
On slide 23, there is only a 10 dB improvement at 8000 Hz (really, negligible improvement) for only 4 out of 15 people. That's like nothing, not worth pursuing any treatment just for that...
... that's just not true. I have had hearing problems for many years, and my hearing has gotten worse very slowly, progressively, and has gone faster in the last 3 years. Well, at the outset, with minor hearing loss at and above 6000 Hz (-25 dB), one can hear almost perfectly. Those frequencies are not important for speech recognition, and this is something accepted by most ENTs.
The important frequencies are in the low range, and in my case this is the big change I noticed, when 500 - 2000 Hz fall from 0 dB to -15 dB or -20 dB there is a difference in speech recognition in noise. And that's specific for that frequency range, for the low frequencies.
This. If safety is established, especially in regenerative technology, there needs to be a way to bypass further efficacy trials. If the biggest gamble is that it doesn't work, at least we don't waste another 2-3 years of our lives chasing waterfalls.
For the record, I don't think FX-322 is a waterfall. I really think this is going to be a major revolution for some 50-90% of us, depending on a few questions that I need answered in the postponed Tinnitus Talk Podcast interview.
- Apr 6, 2020
- 1,031
- Tinnitus Since
- 2016
- Cause of Tinnitus
- 2016: headphones, 2020: worsened thanks to Rammstein
Gee thanks for answering @AtlasFainted. It would certainly be better if it goes straight to the market. I just saw this article (https://www.businesswire.com/news/h...utics-Business-Updates-Reports-Fourth-Quarter). In this article, they mentioned about a 2B and possibly a 3rd trial in Asia and Europe. Maybe we have different systems (as I live in the Netherlands) that determine the release date of medicines, but I do hope that the US and Europe are on the same line when it comes to putting FX-322 on the market ASAP.
- Aug 28, 2019
- 1,496
- Tinnitus Since
- -
- Cause of Tinnitus
- -
WickedCarnival
Member
- Aug 16, 2018
- 68
- Tinnitus Since
- Late Autumn 2016
- Cause of Tinnitus
- Unsure between azithromycin or viral infection
There is a lot of reasons to fix that.
1. Energy in ultra-high frequencies is important for clarity especially in social environments and rooms that contain echo and reverb:
https://journals.lww.com/thehearing...=2017&issue=03000&article=00008&type=Fulltext
http://canadianaudiologist.ca/issue/volume-5-issue-2-2018/hidden-versus-not-so-hidden-hearing-loss/
2. Many tinnitus suffers also show loss in frequencies higher than the edge of their tinnitus frequency:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4438350/
Although the conclusion of this particular research project said that the exact (or close approximation) frequency of tinnitus wasn't significantly correlated with the edge of the high-frequency loss, it was reported that patients had tinnitus frequencies that were higher than the edge of the hearing loss on the audiograms. This shows that we can at least get some useful information through extended high-frequency audiometry.
WickedCarnival
Member
- Aug 16, 2018
- 68
- Tinnitus Since
- Late Autumn 2016
- Cause of Tinnitus
- Unsure between azithromycin or viral infection
Just a question for any Canadians that are familiar with drug approval process. Would the fact that FX-322 is fast tracked by the FDA hold any weight in getting it to Canada within a few years? I would hope the safety data and efficacy evidence would be enough but I heard each country has to run its own trials.
Here are the links to their Cowen and JP Morgan presentations:
https://investors.frequencytx.com/events-and-presentations
- Sep 21, 2016
- 1,051
- Tinnitus Since
- 2011 - T, 2016- H, relapsed 2019
- Cause of Tinnitus
- noise-induced
Yeah agreed I think this drug has the potential to bode really well
Remember this was just a safety dose with one injection so it's entirely viable that further administration should yield more substantial improvements.
The graphic did but that likely more to do with the SEC rules on predictive statements which the graphic could be seen as one. Their phase 1 data only proved efficacy at that range so technically they can't show it going further than that until after phase 2. Put it another way, nothing has changed between phase 1 and now and it is a quadruple blinded study so the stats wouldn't have been analyzed yet. The "change" has to be for SEC reasons because it could be considered unduly influential on stock price.
They have said in their presentations they believe it will be effective above 3500Hz though.
- Aug 28, 2019
- 1,496
- Tinnitus Since
- -
- Cause of Tinnitus
- -
Ah that would be awesome, for some reason Hungary seems to be a favored destination for these types of clinical trials, we also had the AM-101 trial (in fact I got Google Ads asking if I'd be interested in trying out a drug for acute tinnitus). Catch me camping outside the recruitment office at 4AM if this happens for FX-322!
- Feb 14, 2020
- 1,630
- Tinnitus Since
- 1-2019
- Cause of Tinnitus
- 20+ Years of Live Music, Motorcycles, and Power Tools
Thoughts on a 10 dB improvement being "no big deal." I offer the following:
As it relates to the discussion 10dB increase at 8kHz in 4/15 patients; keep in mind with real numbers, a ceiling effect applies. If there is no damage to repair/regenerate, then FX-322 probably didn't cause an improvement.
Let's look at the numbers in the presentation, which IMHO, are revealing: Page 19.
So the 9/15 patients were classified with Mild Hearing loss and received FX-322. It's possible there wasn't 10dB in improvement to be had at 8kHz.
Whereas, the 6/15 patients with Moderate to Moderately Severe Hearing loss had more room for improvement.
Frequency reminds us in the presentation numerous times that "4 of the 6" Moderate to Moderately Severe participants showed statistically significant improvements.
So, I find it interesting that 4 also showed an improvement of 10 dB at 8kHz.
Is this significant? My non-scientific assessment below:
As it relates to hearing level, it might be considered clinically significant for a patient to improve in hearing level.
Assuming the 4 were in the class with a "room for improvement" this tells me that a 10dB improvement might mean an improvement from a Moderately-Severe classification to Moderate, or Moderate to Mild.
Would it be a big deal to have your hearing classification upgraded from Moderate to Mild after a visit to the ENT?
As it relates to the discussion 10dB increase at 8kHz in 4/15 patients; keep in mind with real numbers, a ceiling effect applies. If there is no damage to repair/regenerate, then FX-322 probably didn't cause an improvement.
Let's look at the numbers in the presentation, which IMHO, are revealing: Page 19.
So the 9/15 patients were classified with Mild Hearing loss and received FX-322. It's possible there wasn't 10dB in improvement to be had at 8kHz.
Whereas, the 6/15 patients with Moderate to Moderately Severe Hearing loss had more room for improvement.
Frequency reminds us in the presentation numerous times that "4 of the 6" Moderate to Moderately Severe participants showed statistically significant improvements.
So, I find it interesting that 4 also showed an improvement of 10 dB at 8kHz.
Is this significant? My non-scientific assessment below:
As it relates to hearing level, it might be considered clinically significant for a patient to improve in hearing level.
Assuming the 4 were in the class with a "room for improvement" this tells me that a 10dB improvement might mean an improvement from a Moderately-Severe classification to Moderate, or Moderate to Mild.
Would it be a big deal to have your hearing classification upgraded from Moderate to Mild after a visit to the ENT?
- Mar 14, 2020
- 180
- Tinnitus Since
- 12/19
- Cause of Tinnitus
- Noise Exposure + Viral Infection
Lots of veterans are still coming back from tours with hearing damage. Gunshots & bomb blasts are deafening, and sometimes you don't have the time to dawn hearing protection when you're being attacked.
Ear plugs and batteries for earmuffs are also often lost in the field.
Tinnitus for one. Most people with tinnitus don't have serious damage at speech frequencies, they have damage at (> 8kHz)
The higher frequencies are also important for clarity, detail, and hearing speech in noise. Also what about other sounds? Like music or birds chirping? This stuff all goes into the higher frequencies.
I also think FX-322 will reach the lower frequencies, either increased dosing or a better delivery vehicle is required. Both of these things are trivial compared to developing the drug to begin with.
You might find this study interesting:
https://www.researchgate.net/public..._Unusually_Good_Speech_in_the_Profoundly_Deaf
It turns out the high and the low frequencies both help with speech clarity, so in your case you were able to compensate for the higher losses with good low frequency hearing.
This is also why audiologists worry about that range, it's what hearing aids can cover and as long as they have that base covered, speech is relatively easy. Hearing aids don't do much for higher frequencies because of the high sampling rate that is required and the limitations of current technology. So while there is more speech information at the lower frequencies, profoundly deaf people with normal ultra high frequency hearing (rare but does occur) have "unusually good speech."
- Mar 14, 2020
- 180
- Tinnitus Since
- 12/19
- Cause of Tinnitus
- Noise Exposure + Viral Infection
Yeah I agree. I don't want to get into politics, but I've never agreed with the fact that it's illegal for a buyer & seller to have a consenting transaction until years & tens of millions of dollars are spent in FDA trials.
Just look at what happened with the Hough Pill. It was just sitting there, for far too long, because they didn't have the funding for trials.
I do think drugs should be vetted by the FDA or other organizations (hell, let them compete and become more efficient), I just don't think it should be illegal to buy or try things that aren't vetted yet. Let individuals and their healthcare provider decide if it's worth trying something unvetted.
There's so many horror stories of families having to smuggle unapproved drugs into the country for their loved ones.
It really is not comforting to me that the government has a total monopoly on who can get what treatments.
There's presently so many promising therapies that we could be getting in months, not years (FX-322 included), if they didn't have to go through the behemoth hurdle of the FDA.
Having an alternative for vetting would also help smaller biotech companies keep from being bought out by big pharma, who is known to shelf or delay drugs if it favors their business model.
I could go on, but I'll stop here.
- Mar 14, 2020
- 180
- Tinnitus Since
- 12/19
- Cause of Tinnitus
- Noise Exposure + Viral Infection
It's not likely that Europe will get it as soon as the US does. FX-322 will likely have to go through each European country's drug approval agency, the way it went through the FDA here. Lots of Europeans have discussed flying over here and getting the treatment when it comes out.
However, a 10 dB deviation (improvement or worsening) is within the error range of an audiometric test. I mean, sometimes one finds differences of up to 20 dB in different audiograms, performed with the same audiometer and they dont mean anything in the long run. The differences can be due to congestion, blocked eustachian tube, and many other things.
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