Frequency Therapeutics — Hearing Loss Regeneration

How did they know the synapse count after noise exposure? Probably this were some animals that were tested. As far as I know you can look at the synapses only if you surgically remove the cochlea. But anyhow it might give a hint what happens in humans.
Totally agree with your statement, it's more a hint of what can happen in humans.
 
Since this drug is tested for hearing loss across the 250 Hz - 16000 Hz range, I hardly see any room for off label prescription. They're basically covering everything now, aside from ultra, ultra high frequency hearing loss.
Potential IHC loss (without OHC) as occurs in some ototoxins would be an example. As would people who have more mild loss and notches between measured frequencies without enough widespread loss to show up on tested audiogram frequencies would be another example.

I think it will definitely be used off label in people with "normal" audiograms, even extended ones.
 
How did they know the synapse count after noise exposure? Probably this were some animals that were tested. As far as I know you can look at the synapses only if you surgically remove the cochlea. But anyhow it might give a hint what happens in humans.
They have done autopsy studies in humans too.
 
Just read this article about Hidden Hearing Loss and all will make sense:

https://leader.pubs.asha.org/doi/10.1044/leader.FTR1.22072017.48

Just some quotes from this article:
"You can lose 50 percent of your synapses in minutes after a noise exposure, but it might take you a full lifetime to lose that number with aging."

"And while the causes and extent of HHL in humans and its implications for public health are still up for debate, the notion that it could soon be time for audiologists to expand their standard assessment arsenal beyond pure-tone audiometry in quiet is less controversial."
It is very hard to find an audiologist in Australia who will actually do speech in noise testing. Although it seems that there is more of this being done now.
It sucks that OTO-413 and Hough Pill are so far behind in their trials to help restore synapses. I just hope hyperacusis and tinnitus are caused by OHCs and IHCs rather than synapses so that FX-322 will definitely help everyone with noise damage.
Inevitably I think that we will have a treatment for damaged synapses, although the question is how far away are we from having one.

Otonomy, Hough and also Pipeline are working on synapse related treatments. Hough has predicted an availability of 2025 or before. And I am pretty certain Otonomy and Pipeline are commencing clinical trials either this year or early next year. I still believe we may have a synaptic treatment available prior to Hough's, especially if one of the others turns out to be successful.
 
It is very hard to find an audiologist in Australia who will actually do speech in noise testing. Although it seems that there is more of this being done now.

Inevitably I think that we will have a treatment for damaged synapses, although the question is how far away are we from having one.

Otonomy, Hough and also Pipeline are working on synapse related treatments. Hough has predicted an availability of 2025 or before. And I am pretty certain Otonomy and Pipeline are commencing clinical trials either this year or early next year. I still believe we may have a synaptic treatment available prior to Hough's, especially if one of the others turns out to be successful.
I'm pretty sure we will get a Phase 1/2 readout from Otonomy in Q4/2020.
 
FREQ share price dropped up to 15% today. Any idea if there was a catalyst for it or just good ole nature of biotechs? Can't find anything.
From what I can observe, it is highly probable that this had a lot to do with the sector more than anything. There doesn't seem to be any specific news relating to Frequency Therapeutics or any of the other biotech firms that had price declines.

Just seen reports informing us that Trump has talked about what he is going to do to restrict prescription medicine price increases. It is likely that this would explain why there has been a fall in the sector overall.
 
FREQ share price dropped up to 15% today. Any idea if there was a catalyst for it or just good ole nature of biotechs? Can't find anything.
A lot of biotechs are way down (Arcturus is also down 13% for literally no reason). The IBB is down too.

Per Stat News there was a deadline today for an agreement with pharma companies and that deadline passed. It's the only thing I could find.

https://www.statnews.com/2020/08/21/phrma-scrambles-drug-pricing-ultimatum/
 
From what I can observe, it is highly probable that this had a lot to do with the sector more than anything. There doesn't seem to be any specific news relating to Frequency Therapeutics or any of the other biotech firms that had price declines.

Just seen reports informing us that Trump has talked about what he is going to do to restrict prescription medicine price increases. It is likely that this would explain why there has been a fall in the sector overall.
Didn't see this. You beat me to it and I agree.
 
I have read with interest some references in the forum about Frequency Therapeutics potentially planning research into male baldness in the hopes of producing game-changing treatment.

I have failed to find any news articles of this company addressing this issue.

Anyone else?
 
I have read with interest some references in the forum about Frequency Therapeutics potentially planning research into male baldness in the hopes of producing game-changing treatment.

I have failed to find any news articles of this company addressing this issue.

Anyone else?
Frequency Therapeutics have mentioned before at a conference about treating baldness and cartilage disorders (@FGG said this).

Frequency Therapeutics have also filed patents for hair follicle proliferation to treat baldness:

http://appft.uspto.gov/netacgi/nph-...peutics&FIELD1=&co1=AND&TERM2=&FIELD2=&d=PG01
 
I have read with interest some references in the forum about Frequency Therapeutics potentially planning research into male baldness in the hopes of producing game-changing treatment.

I have failed to find any news articles of this company addressing this issue.

Anyone else?
No. Nothing seems to have been released regarding a proposed baldness treatment.

I think that it will be highly likely that Frequency Therapeutics will work on a baldness treatment. However I also believe that this will not be a priority, especially when compared to other treatments that Frequency Therapeutics are considering. Currently there are numerous treatment options that are available to treat baldness such as hair regrowth treatments and hair transplants.

Therefore I think that Frequency Therapeutics will focus on novel areas of treatment like they are currently doing with Multiple Sclerosis and hearing. These are far more lucrative from a financial perspective from the simple fact that at least for now they will be a monopolised treatment. This will mean that Frequency Therapeutics can charge a higher price for the medicine and also won't need to compete with other entities for market share either.
 
Frequency Therapeutics have mentioned before at a conference about treating baldness and cartilage disorders (@FGG said this).

Frequency Therapeutics have also filed patents for hair follicle proliferation to treat baldness:

http://appft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&p=1&u=/netahtml/PTO/search-bool.html&r=0&f=S&l=50&TERM1=frequency+therapeutics&FIELD1=&co1=AND&TERM2=&FIELD2=&d=PG01
@Billy_Shears, they had a graphic up at one of the earlier conferences where they described both baldness and joint disease as future applications of their PCA platform. They aren't going to have press releases on this because they are still very pre-clinical for these applications at this point. For now, the company is focused on two applications: hearing loss and MS.
 
Frequency posted this on their Twitter - a discussion on what the future of hearing loss treatment could look like and how it might benefit patients, with Carl LeBel. This was from the virtual Hearing Loss Association of America (HLAA) convention earlier this summer.

 
Frequency posted this on their Twitter - a discussion on what the future of hearing loss treatment could look like and how it might benefit patients, with Carl LeBel. This was from the virtual Hearing Loss Association of America (HLAA) convention earlier this summer.
This was a great interview. Tinnitus wasn't specifically asked about but it was interesting to have practicing clinicians on the panel with LaBel.

A few new points:

-There might be benefit even in patients who already have cochlear implants. One ENT or Otologist (can't remember which she was) pointed out that improved hair cell function sends signals to the auditory nerve and would improve auditory nerve function. Really interesting and something I had never heard before.

-Frequency Therapeutics was blinded in the last study until the completion. Since we can assume they are again blinded the same way, stock fluctuations and c-suite trading is probably completely meaningless in terms of the anticipated effectiveness of the drug.

-Hearing aids apparently suck so bad that only about 1 in 6 people use them even when they have bad hearing and even when they are free. Everyone on the panel agreed regenerative medicine will blow them out of the water.

-The clinician on the top left said she thinks people without much clinical hearing loss will benefit from regenerative medicine and she plans to use regenerative drugs in that population too. So for everyone worried doctors won't give them the drug with a normal audiogram, go see her at that point (I'm sure she wouldn't be the only one).

-Dr. LeBel said for sure they expect drug release this decade but wasn't able to say more than that conservative estimate. He did give a hint that people could use to "estimate a better timeline" (since he couldn't come out and give his own estimate) by saying cardiac drugs take 5 years for phase 3 but they are able to enroll hundreds (instead of thousands of patients) because there is zero concern to the FDA that hearing improvements could be placebo. I get that it means (much shorter) but what that means is anyone's guess).

Anything else I miss?
 
FREQ share price dropped up to 15% today. Any idea if there was a catalyst for it or just good ole nature of biotechs? Can't find anything.
This COVID-19/Election Year 2020 mess creates a volatile stock market at times to no culpability placed on Frequency Therapeutics itself or even the bio-tech industry as a whole. FREQ will shine through and in a big way. I am quite confident and have no worries of my investment in this company.
 
Frequency posted this on their Twitter - a discussion on what the future of hearing loss treatment could look like and how it might benefit patients, with Carl LeBel. This was from the virtual Hearing Loss Association of America (HLAA) convention earlier this summer.
I think that it can benefit people positively and I also actually think that it is a positive sign observing Frequency Therapeutics engage with many stakeholders. Still I feel that just like I explain below why doctors might be initially unwilling to treat patients, I also feel that there might be the same sort of apathy also from doctors.
I really hope that FX-322 is the breakthrough they need to give ENTs a reason to actually focus more on the ear, and treat people.
If it is successful (and I think it will be successful), I believe that there will still be problems with convincing many ENTs to treat patients with FX-322 initially. I reckon that there will be a mixture of skepticism and refusal from some. Others however will obviously be willing to treat.

The most likely obstacle patients may face is finding a doctor who would be willing to work with them for the duration of their course of treatment. FX-322 is inevitably going to be a treatment that requires a lot of investigatory and also trial work to get the treatment right, especially in the initial stages. Thus this will not be something that many doctors will want to take on because it will be time consuming and not necessarily simple for them like deciding to do ear tubes. Furthermore it may be less financially beneficial for them when compared to other treatment options they could provide.

Thus I believe that until doctors either

- recognise the benefit in providing FX-322 treatment to people

or

- there are improvements in the ease of delivering FX-322 to patients and these improvements clearly result in the treatment becoming simpler to administer to people

There will be quite a lot of apathy for doctors to administer FX-322 or even learn about it so they can actually administer it.

For example doctors in Australia consistently refuse or resist to learn new procedures until there is a demonstrable benefit to them or some other reason for doing so. I assume this happens in other places also. As a result I feel that until Frequency Therapeutics can lay the ground work and actually convince doctors to treat using FX-322 there will be a barrier for patients to be able to obtain treatment.
 
The timeline of up to 10 years before deployment was depressing for someone my age (just turned 50) but it's better than having nothing to look forward to.
I personally suspect that it could be much less than that - they can't really give away any official timelines and are probably erring on the conservative side for now, but LeBel's made it implicitly clear IMO that they are going to try and get this on the market as fast as possible. It was heartening to hear him say that the Phase 3 trials will probably be on the shorter side and don't require thousands of participants. The fast-track status and breakthrough therapy should also expedite things also I don't think this was mentioned in the interview. Plus, there's the possibility of compassionate use once this next phase is concluded.
 
The timeline of up to 10 years before deployment was depressing for someone my age (just turned 50) but it's better than having nothing to look forward to.
He said that but almost gave a wink that you could use cardiac studies as a comparison to get a better timeline. It seemed like he had to say within a decade to be as conservative as possible without making promises while offering that cardiac study phase 3's take 5 years but theirs would be shorter. That's how I took that anyway.
 
He said that but almost gave a wink that you could use cardiac studies as a comparison to get a better timeline. It seemed like he had to say within a decade to be as conservative as possible without making promises while offering that cardiac study phase 3's take 5 years but theirs would be shorter. That's how I took that anyway.
In 4 years, the pace at which FX-322 has gone from a publication in 2017 (Cell Reports) to a Phase 1 Trial, then a Phase 2 Trial (ending Q2,2021); it's hard to imagine the trials spanning out another 5 years, let alone 10.

LeBel also mentions that a Phase III would likely require "hundreds" instead of "thousands" of participants. So, I would anticipate recruiting being much less of an issue. Not to mention, increased awareness amongst doctors and patients.
 
The timeline of up to 10 years before deployment was depressing for someone my age (just turned 50) but it's better than having nothing to look forward to.
I must have missed that 10 years bit.

Goddamn, I will be 60 if it takes 10 years.

Let's hope it comes within 5. Got to think positive! It's all we've got.
 

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