Frequency Therapeutics — Hearing Loss Regeneration
- Thread starter RB2014
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sensualmosquito
Member
- Jul 11, 2020
- 81
- Tinnitus Since
- June 2020
- Cause of Tinnitus
- 6-8 khz HL, T and H from gunshots
The Phase 1 was only for safety, however it did also show what Frequency Therapeutics is calling a "hearing signal" i.e. a pure tone improvement at 8 kHz with 4/15 subjects, and improvements in word recognition scores. Phase 2 is designed to further establish the potential of this hearing signal, while also monitoring adverse reactions and safety concerns. This time they are using several doses of the drug to see if this provides further improvement.
Member- Apr 23, 2019
- 364
- Tinnitus Since
- 04/2019
- Cause of Tinnitus
- Slap to the ear / Leading to more issues after ear surgery
FGG... So I have a quick question for you. If you have noise induced hearing loss, for instance a V knotch at 4,000 Hz (-40 dB) and your conductive tests are the same as your PTA tests (-40 dB), is it your opinion that FX-322 could increase both if the drug actually works?
Every ENT has told me my V notch (both ears) is noise induced (nightclubs, ear buds etc) AKA nerve loss. Could FX-322 raise both, your conductive audiogram as well as PTA test results? I'm a little confused on this issue...
I'm very optimistic too. When you say they know if it works, what do you mean? I think we need the trials to figure that out.
- Feb 14, 2020
- 1,630
- Tinnitus Since
- 1-2019
- Cause of Tinnitus
- 20+ Years of Live Music, Motorcycles, and Power Tools
Without question, ENT offices will be overloaded with wait lists the first few years. In the US, there simply are not enough offices to handle even 10% of potential market attempting to schedule appointments. Many assumed that having an established ENT will help get you an appointment. It's highly possible that we see more practices spring up that specifically focus on hearing regeneration; or that Audiologist practices begin seeking some type of certification/education on intratympanic injections to treat patients with FX-322 without referral.
As for production... Astellas is ONLY the manufacturer for FX-322 to be manufactured, distributed, and sold in NON-US locations. Frequency Therapeutics plans to use a US-Based Contract Manufacturer for US-ONLY distribution. These same type of contract manufacturers are used for mass-producing the COVID-19 vaccine by Moderna and Pfizer in the US. Frequency Therapeutics has not yet announced which manufacturer they will select for US-ONLY manufacturing and distribution of FX-322, this will be a priority of their new Chief Manufacturing Officer hired in January.
From what we know, and what Frequency Therapeutics has routinely said in investor webinars is that since FX-322 is a two-molecule drug, they persist that it should be "cost-effective and simple" to manufacture in mass quantities. We know that 1 molecule in FX-322 is Sodium Valproate; which has been manufactured for a better part of a century and is relatively cheap. The other proprietary molecule, which I cannot recall right now, is more expensive to obtain from a lab, but not prohibitively more expensive. It seems that separately, the molecules are readily available, which is promising.
What we don't know yet that may affect final distribution are things like: Storage requirements (does a doctor's office need a special fridge?), how the doses will be sold (do you have to buy them in a set of two doses?), down-line supply challenges (how much Sodium Valproate and the other molecule are available to ramp up millions of doses worldwide)?
I'm sure once they know the stuff works, they will want it out as quick as possible. Gotta make that money while they have a patent.
I actually meant word recognition scores. Anyway, that's not going to help any of us. We are looking for audiogram improvements. While I think it is going to work, to say it works for sure is not true.
Koz
Member
- Dec 15, 2013
- 153
- Tinnitus Since
- 2009
- Cause of Tinnitus
- Unilateral sensorineural hearing loss
Just hoping to ask if anyone knows the answer as I'm a bit at my wits' end (and at the point of just giving up on hearing restoration at all for my bad ear), seeing as FX-322 works on support cells potentially up to severe damage... now for those with a severe to profound hearing loss - would the support cells in the severe range activated by FX-322 also be able to regrow dead hair cells in the profound range/frequencies or are those gone for good? (i.e - FX-322 only acts on fixing the severe range hair cells/frequencies?). I've read others state that profound cases could be resolved way down the line but was wondering if that's only for full profound hearing loss.
I ask because I'm at the severe to profound range (4 frequencies at severe and 4 at profound) with my bad ear now and don't know if there's even any point in trying to prevent further damage in that ear. Doctor says it's more so genetic rather than strictly noise induced (even with loud noise playing a factor), although this was acquired in a progressive manner in my adult years rather than sudden or since birth.
I think I once read there was a drug in development for severe to profound hearing loss, name beats me though. I was hoping FX-322 was all I was going to need up until this latest worsening :/
I ask because I'm at the severe to profound range (4 frequencies at severe and 4 at profound) with my bad ear now and don't know if there's even any point in trying to prevent further damage in that ear. Doctor says it's more so genetic rather than strictly noise induced (even with loud noise playing a factor), although this was acquired in a progressive manner in my adult years rather than sudden or since birth.
I think I once read there was a drug in development for severe to profound hearing loss, name beats me though. I was hoping FX-322 was all I was going to need up until this latest worsening :/
I guess you mean specifically for tinnitus/hyperacusis-related ailments? I think we are talking passed each other.
The bottom line is; the drug does work in terms of repairing hair cells, but whether that will help everyone with tinnitus/hyperacusis "for sure" is not true, correct.
- Feb 14, 2020
- 1,630
- Tinnitus Since
- 1-2019
- Cause of Tinnitus
- 20+ Years of Live Music, Motorcycles, and Power Tools
Word score improvements (WR & WIN) indicate that the brain is receiving more detailed signal from new hair cells (IHC and OHC), and is therefore able to distinguish the fine differences between syllables in words. In particular, consonants. If you agree that tinnitus is perhaps a symptom of the absence of hair cells, this may be the first indicator that hairs are filling back in areas where there previously was tinnitus present.
There were audiogram improvements seen at 8 kHz (and presumably above). Audiogram fails to tells us anything about IHC performance, only OHC. The audiogram isn't detailed enough to give us a perfect measurement of how deep the improvements went. Which makes it not a great measuring device. For example, of those that saw improvements at 8 kHz, we have no idea at what specific frequency the improvements stopped until the 4 kHz marker on the audiogram. Could have been 6 kHz, 7 kHz, or even 4.1 kHz.
Street Novelist
Member
- Apr 2, 2018
- 290
- Tinnitus Since
- February 2018
- Cause of Tinnitus
- Listening to loud music through headphones
What do you mean by that? Do you know something we don't? They said they will release the results at the end of Quarter 1. March is the last month in Quarter 1.
There seems to be a fundamental misunderstanding in much of this thread.
Post after post says "when FX-322 is approved…" and "since we know it's safe…" and "since we know it works…."
We don't.
Clinical trials are literal experiments and no one, including Frequency Therapeutics, knows the ultimate results. Positive early stage trials, limited in scope, move the process forward, but hardly prove "it works, it's safe, it will be approved." In fact, many drugs advance through limited early-stage trials only to flame out in larger later-stage trials.
I desperately hope, like everyone here, that it works, it's safe, and it will be approved – ending our suffering. And there's a growing pile of positive tea leaves to suggest that will happen.
Furthermore, and perhaps why this thread isn't like any other thread in the forum, FX-322 isn't like any other treatment discussed in the forum (at least one this far along). Most seem to be some form of Band-Aid, wonderful, for sure, if they work, but Band-Aids. FX-322, by comparison, would be an actual cure. It's the promise of regenerative medicine, the holy grail of tinnitus and many other vexing conditions, and fires our imagination and hope unlike anything else…
… if it works, if it's safe, if it's approved.
Hopefully, hopefully, it's all three, and as fast as goddamn possible, but we just don't know that yet. No one does.
Rinri Therapeutics is developing a treatment using pluripotent stem cells and converting them into functional hair cells. I reached out to them last week and they stated that their treatment would be effective for severe and profound hearing loss as the treatment does not utilize support cells. They also said they are anticipating going into clinical trials 2-3 years from now (bummer I know). They presented at a webinar sponsored by Hearing Medicines Discovery Syndicate that I found very informative and can be found here:
The Emerging Hearing Medicines Landscape Webinar Series – Webinar 4: The Challenges and Opportunities for Emerging Cell and Gene Therapy Approaches to Address Hearing Loss
I think most of us are aware there is a likelihood this drug may not work. We remain hopeful it does, and if it doesn't work we will still remain hopeful that something else will. Personally, having hope helps keep me going.
Why wouldn't they know at 6 kHz? Every hearing test I've had they checked that frequency. I've had them done at six different places.
Keith Handy
Member
- Jan 5, 2021
- 302
- Tinnitus Since
- 11/2020
- Cause of Tinnitus
- Stress + sleep deprivation + noise
0.25 Hz? Are we supposed to feel irregularities in the earth's rotation or something?
Does anyone have any thoughts on when they think Frequency Therapeutics got (or will get) the Day-90 data and how long it will take to do their analysis?
They announced they had completed enrollment on September 22nd. 90 days from that date is December 21. My feeling is that means they would probably have gotten the data in early January. From there it'd probably take them around 6 weeks to analyze the data and put together a presentation. So that would mean we would see something at the beginning of March.
Am I missing something? The more I think about this, if my timeline is correct, they technically could put out something in mid-to-late February too.
They announced they had completed enrollment on September 22nd. 90 days from that date is December 21. My feeling is that means they would probably have gotten the data in early January. From there it'd probably take them around 6 weeks to analyze the data and put together a presentation. So that would mean we would see something at the beginning of March.
Am I missing something? The more I think about this, if my timeline is correct, they technically could put out something in mid-to-late February too.
- Feb 14, 2020
- 1,630
- Tinnitus Since
- 1-2019
- Cause of Tinnitus
- 20+ Years of Live Music, Motorcycles, and Power Tools
- May 27, 2020
- 556
- Tinnitus Since
- 2007
- Cause of Tinnitus
- Loud music/headphones/concerts - Hyperacusis from motorbike
It's so they know whether we can now hear the murmuring of our doctors when they say there's nothing wrong with us.
- Feb 14, 2020
- 1,630
- Tinnitus Since
- 1-2019
- Cause of Tinnitus
- 20+ Years of Live Music, Motorcycles, and Power Tools
You didn't figure for the 4 doses that takes place after completing enrollment. So it was probably more like:
September 22: Last patient enrolled
1 week later: Dose 1
2 weeks later: Dose 2
3 weeks later: Dose 3
4 weeks later: Dose 4
8 weeks: 30-day assessment
By my assessment, they probably got the raw interim data this past Friday. If not, this week. I'd put it all at mid-March tbh. The Cohen Healthcare conference would be a good event to reveal the data.
You're right, I knew I had to be overlooking something. Yeah, the data is probably due to arrive in early February, so they either just got it or they'll get it soon. Mid to late March is probably the most realistic time to expect results.
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