I think it's very likely that effective treatment for hearing loss and tinnitus will entail a combination of treatments, just like most complex diseases.
Frequency Therapeutics — Hearing Loss Regeneration
- Thread starter RB2014
- Start date
I think they explicitly stated recently that the dosage they are using is exactly the same as the dosage in phase 1b. It may have been in their press statement after the Germany trial.
Edit:
Ok: "In the study, seven subjects received a single dose of FX-322 at the same dose level given in the Company's Phase 1/2 study and its ongoing Phase 2a study."
https://www.businesswire.com/news/h...eutics-Shares-Clinical-Data-Exploratory-Study
To quote their press release of the Hannover study:
"In the study, seven subjects received a single dose of FX-322 at the same dose level given in the Company's Phase 1/2 study and its ongoing Phase 2a study."
https://investors.frequencytx.com/n...eutics-shares-clinical-data-exploratory-study
In other words, Phase 2a uses the same dose per injection as the Phase 1/2 study.
https://investors.frequencytx.com/n...eutics-shares-clinical-data-exploratory-study
In the study, seven subjects received a single dose of FX-322 at the same dose level given in the Company's Phase 1/2 study and its ongoing Phase 2a study.
This sounds like its same dose.
Sure. Hopefully OTO-413 will work. I think they said in their recent presentation that the results of the efficacy study will be published in Q4 this year.
My interviewer told me they were using a higher dose when I applied for the trial.
That was the dose used for the perilymph study, not 2A.
The perilymph study is separate. The current 2A uses a different dose.
Member- Sep 21, 2016
- 1,051
- Tinnitus Since
- 2011 - T, 2016- H, relapsed 2019
- Cause of Tinnitus
- noise-induced
10 dB is very perceptible by our hearing apparatus.
Whether that is enough for our doctors to qualify it as "hearing loss" is orthogonal to our ability to perceive it. I'd love to have 10 dB improvements to my hearing (anywhere).
Can you point me to where they said it's the same phase 1 dose 4 times. I have not seen that reported anywhere apart from the Pharmocokinetics study they just did with the phase 1 dose in Germany on the cochlear implant patients.
I did, not much new information. Here are some things I found interesting that Carl LeBel said, I'm paraphrasing here.
"We're either close to a breakthrough or there."
"Hearing drug trials have the advantage of patients not being subjective to improvement."
"Approval is still a few years away, but a therapeutic will be released this decade."
"We're thinking of hundreds instead of thousands of patients participating in the entire trial process."
Where does it say they use a different dose? C'mon now, it's in their own press release from just a few weeks ago.
- Feb 14, 2020
- 1,630
- Tinnitus Since
- 1-2019
- Cause of Tinnitus
- 20+ Years of Live Music, Motorcycles, and Power Tools
It was mentioned in the Goldman Fireside chat. Carl LeBel mentioned that the Phase 2A was using the same dose as the Phase 1/2, except 1x 2x 4x delivered. He also reiterated that they are hoping to see the similar results from single-dose patients in the Phase 2A as they did in the Phase 1/2.
- Feb 14, 2020
- 1,630
- Tinnitus Since
- 1-2019
- Cause of Tinnitus
- 20+ Years of Live Music, Motorcycles, and Power Tools
Notes from the HLAA discussion:
Generally not too much new... some key take-aways:
Bringing Regenerative Medicine into Practice
Who benefits the most?
What is needed to bring FX-322 into practice
Generally not too much new... some key take-aways:
Bringing Regenerative Medicine into Practice
Who benefits the most?
- Anyone can benefit
- Mild hearing loss to profound
- As long as hearing signal can be turned on through regeneration
- Regenerating structures of the ear also means helping cochlea stay healthy
What is needed to bring FX-322 into practice
- Clinical trials reviewed and approved by FDA
- Experts to help shape policy and practice guidelines
- Working with patient groups
- By the time the drug is approved, everybody is ready to get to work.
- Will happen in this decade, available in several years.
- Phase 3
- Most likely on the "Shorter end of the Phase 3 spectrum"
- Likely require hundreds of patients, not thousands
HootOwl
Member
I was pretty astounded by this exact thing when my audiologist tested me for word recognition in quiet.
He started at 15 dB and then dropped to 10 dB and finally to 5 dB. The difference between 15 dB and 5 dB was extremely noticeable, despite only being 10 decibels apart which kind of shocked me.
I could barely hear 5 dB but could easily make out and understand the words at 15 dB.
I intented to but I only caught the end :/
My brother graduated today so I got caught up.
Coleoptere
Member
At least the placebo dose is the same. 
It is very interesting that they may inject a higher dose than dring the 1/2 phase. Did not consider that the FDA allowed a dose higher than the safety one.
It is very interesting that they may inject a higher dose than dring the 1/2 phase. Did not consider that the FDA allowed a dose higher than the safety one.
They don't. It's the same dose as in Phase 1/2. The notion it's a higher dose seems to be something that just won't die.At least the placebo dose is the same.
It is very interesting that they may inject a higher dose than dring the 1/2 phase. Did not consider that the FDA allowed a dose higher than the safety one.
That's really strange because the investigator during my trial interview *specifically* told me higher dose and multiple dosing.
The investigator could have just misspoken. It wouldn't make any sense to do a safety Phase 1/2 trial for a dose and then up the dose for Phase 2. What's the point of the safety study then?
Plus, Frequency is publicly traded now and still recruiting patients. You can't just announce incorrect information with regards to such a key component as dosage and not get in trouble.
I see no reason to assume that the Phase 2 dosage is higher per injection.
I have been told by my audiologist that the research at present suggests that they can fix it although the two impediments at the moment are that the treatment needs to do what it is wanted to do and that they can deliver it in the area effectively. As a rule for the first part he suggests that you cannot use a treatment that results in cells continuously multiplying because that is actually cancer so they need to get it to just regrow damaged cells. It's also almost absolutely certain that tinnitus is caused by a loss in hearing as a lot of information suggests that noise enhancing devices like headphones or hearing aids reduces tinnitus. Of course you can link the two.
- Feb 14, 2020
- 1,630
- Tinnitus Since
- 1-2019
- Cause of Tinnitus
- 20+ Years of Live Music, Motorcycles, and Power Tools
It's interesting you mention the cells multiplying. In an interview with one of the founders he mentioned that it was observed that after the cell population reaches a certain density, the progenitors stop responding to the drug. So, there's something in the biology of the cells that keeps them from over multiplying.
Also, in a JP Morgan session late last year, they claimed specifically that FX-322 would only activate progenitors where cells are damaged or missing; not where healthy cells exist.
I also tend to believe that if FX-322 was causing some amped-up over-population of hair cells in the cochlea, like you might see with stem cell therapy, it would have failed the safety trial. This is the same reason why some stem-cell treatments have failed safety trials, because there is no way to "switch them off" or its easy to over-do it.
It really doesn't seem to matter what Frequency themselves say about this on their website. They obviously don't know what's going on in their own trials.
Probably not based on any news but it's funny how everyone gets worried with a sell off but kind of ignores the jumps.
It's logical considering FX-322 basically just activates the body's innate ability to regenerate. And since there's a process that regulates this regeneration and (mostly) keeps it from becoming cancerous in the rest of the body, the process should be able to do the same in the inner ear.
However,in this thread John says that oral ingestion of gamma secretase inhibitors (like FX-322) lead to cancerious growths in the whole body.
Why would something lead to cancer if it's administered orally but not if it's administered over the middle ear?
Or is FX-322 different from other gamma secretase inhibitors?
This article highlights the difference with Frequency's approach:
https://www.genengnews.com/news/ast...peutics-partner-to-develop-hearing-loss-drug/
Relevant section here:
"Langer discussed how Frequency's PCA technology compared with a competing approach under study by University College London's (UCL's) Ear Institute that entered clinical trials at about the same time as Frequency Therapeutics' program. UCL's approach, which incorporates a gamma-secretase inhibitor, forces stem cells to convert directly into other types of cells.
"We, however, engage a different part of the signaling pathway. Rather than force cells to become something different, we're causing precursor cells to behave in a native manner, mimicking the biology that humans experience during development," Langer explained."
The gamma secretase inhibitors fed to mice led to severe problems in their stomach and gullet. I recall reading the paper that it burned off their gullet and most died off of diarrhoea, those that survived also developed other problems but I don't remember what... so in the end this sort of killed the way of oral ingestion
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