Frequency Therapeutics — Hearing Loss Regeneration

#16,922
Jaysterk said:
Ok so I've been in and out of here since Frequency Therapeutics posted their trial results. I understand the results were less than favorable.

So for the not so bright like me, are they going to continue with their research? Is one shot potentially more beneficial perhaps if it penetrates deeper into the cochlea... or are we all going to die with tinnitus and hyperacusis? Timelines?
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They will be continuing with their single dose trials as it has shown to be more effective than weekly doses of FX-322. In the future they may try multi-dosing again but spreading it more apart e.g., monthly. The Phase 1b age-related hearing loss trial results will be out in Q2 and Phase 1b severe hearing loss trial results will be out in Q3.

If these two trials have positive outcomes, me and a few others have stated that the FDA may accept these results and the previous Phase 1b trials as enough efficacy for them to go to the pivotal phase but most have been saying that might not be the case and they will need to repeat a Phase 2a. I'm really hoping for a positive outcome which doesn't delay the trials.
 
#16,923
Jaysterk said:
Ok so I've been in and out of here since Frequency Therapeutics posted their trial results. I understand the results were less than favorable.

So for the not so bright like me, are they going to continue with their research? Is one shot potentially more beneficial perhaps if it penetrates deeper into the cochlea... or are we all going to die with tinnitus and hyperacusis? Timelines?
Click to expand...
The past few pages of this thread contain speculations that address your questions.

Concerning one vs. numerous doses, certainly no one knows for sure, though it does seem like there was a consensus here that multiple doses might have caused the trial's failure.

I think @Zugzug provided a nicely reasoned estimate of a potential timeline a couple of pages back... around 15-20 years, I believe. Others suggested less time. Just two weeks ago, I was hopeful we were looking at 2-5 years tops, but now I'll play this like The Price is Right and suggest 21 years. If it's less, that'll be a nice surprise.

Edit: just realized that @Lucifer got to your question more quickly (and accurately) than I. Cheers.
 
#16,924
Street Novelist said:
Can someone explain what cochlear pumping is? I Googled it but couldn't get a definition.
Click to expand...
In a nutshell (from the pre-print at the posted link):

"low-frequency air pressure oscillations applied to the ear canal at 4 Hz, which caused large amplitude (~ 80 µm peak-to-peak) stapes displacement"​

Unlike the other paper I posted a link to, the CP one is pretty readable.
 
#16,925
I have no knowledge.

I have a frank question.

Is it terribly difficult to develop a good sustained-release gel?

Do you think the current FX-322 gel is inferior?
If inferior, I think the improvement is more likely.
 
#16,926
Zugzug said:
It's going to suck if a repeat of Phase 2 approaches and I legitimately start believing in its success again. Right now, it's super easy to be a bear. I'm like a band wagon bear.

When things eventually start succeeding with hearing regeneration (who knows how long that will be?), I'm going to be against the world.

"Zugzug, how do you explain that that none of the placebos improved and 85% of the treated group has clinically meaningful improvements in WR, WIN, and PTA?"

I'll have to come back over if I am check mated and literally can't come up with a bear argument. I don't see this happening anytime soon though.
Click to expand...
We get it bro, you're a bear.
 
#16,929
just1morething said:
I think you mean Frequency Therapeutics scientists fix it.
Click to expand...
Well yeah, no shit. What did you think I meant? That Diesel, Zugzug, FGG, and Aaron91 would be concocting makeshift FX-322 out in a random back shed in the middle of Nowhere, Nevada because Frequency Therapeutics has no desire to improve their drug formulations?

I̶ w̶o̶u̶l̶d̶ w̶a̶t̶c̶h̶ t̶h̶i̶s̶ a̶s̶ a̶n̶ H̶B̶O̶ m̶i̶n̶i̶ s̶e̶r̶i̶e̶s̶ t̶h̶o̶u̶g̶h̶.
 
#16,930
#16,931
This is a good summary on why tinnitus can arise from OHC damage, IHC damage, synaptopathy or basilar membrane displacement (as in Meniere's):

Pathophysiology of Subjective Tinnitus: Triggers and Maintenance

So, if the drug prefers IHCs (especially first pass), it still may be very effective for tinnitus in some people, depending on what is causing it (just like a synaptopathy drug would help tinnitus caused by synaptopathy).

There is no study supporting that tinnitus just arises from one structure (e.g., OHCs).

Though, I see the drug having more potential for OHCs with repeat dosing but at much higher intervals (I think they should continue with single dosing for now though). But, as far as tinnitus assessment goes for the single dose studies, the people with the lowest genuine word scores should see the most improvement.
 
#16,932
HootOwl said:
Well yeah, no shit. What did you think I meant? That Diesel, Zugzug, FGG, and Aaron91 would be concocting makeshift FX-322 out in a random back shed in the middle of Nowhere, Nevada because Frequency Therapeutics has no desire to improve their drug formulations?

I̶ w̶o̶u̶l̶d̶ w̶a̶t̶c̶h̶ t̶h̶i̶s̶ a̶s̶ a̶n̶ H̶B̶O̶ m̶i̶n̶i̶ s̶e̶r̶i̶e̶s̶ t̶h̶o̶u̶g̶h̶.
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Yeah I thought that's what you meant. ;) I thought they would take over for Frequency Therapeutics' scientists. Btw, I like your new avatar better than the clown. I always disliked that one.
 
#16,933
#16,934
Good morning. I am only posting here once, because I feel I owe this message of hope to those that also suffer from sudden hearing loss. I too woke up and had something taken for granted taken away one day without warning and replaced instead with robotic sounds and not being able to hear where sounds were coming from.

If you are suffering also, you were probably told by your otologist you had hearing loss, it happens all the time, and you will adjust.

My story is I was put on a low dose of steroids and told I would get better in two weeks. The problem is it never did. Two university hospitals later and a dozen audiograms indicated my hearing was not recovering and I had permanent moderate/severe hearing loss. You like me were probably basically told medical intervention was 20 years off, but the "good news" is life will go on. What bothered me the most hearing the message is it was from someone that has no life experience to relate to us, but rather a textbook that says we can't cure it. Added to the devastation was being told a hearing aid will not help you and a cochlear implant on one side doesn't always work or is covered by insurance.

I am posting this for those that are hanging on because I somehow found this thread way back in the beginning when it was first started and while searching for answers in life concerning why this happened to me. It gave me hope each day while I tried to make the best out of a life I somehow didn't deserve that was much more like a prison cell in isolation. The scientists and doctors dedicating their lives to helping people like us instead of just dismissing us deserve far much better than the negativity this thread has become.

As for me, let's just leave my story where one day I woke up and my hearing became better.

For those that follow this thread for hope, I truly posted this for you. I owed you all to let you know how the thread kept me going at one time. "Hope" is truly all we have. Please remember my words of advice and take care. :)
 
#16,935
GBB said:
? - can we not invoke medical professionals as if they actually have any useful insight here - you might as well cite your astrology symbol. I've been to 6 or 7 Columbia and NYU doctors and the extent of their knowledge is farcical. They focus on the small fiefdom of medicine that overlaps between treatable, lucrative, and common, anything else you might as well ask a Rabbi, an imaginary friend, or your pet.
Click to expand...
I'm of the opposite mindset, as I believe a formulation of opinion should come from many sources, not just ones to appease confirmation bias. Do you believe that you have more useful insight on the matter? Or are you merely taking a jab at my opinion because it counters your own?

BTW I did ask my pugs, they say they're cooking something up in their skunkworks, yet all I smell when I walk by is kibble and canned meat concoction. I think it's just a scam to receive my grant money. We'll see when they release their Phase 1 results.
 
#16,936
HootOwl said:
Well yeah, no shit. What did you think I meant? That Diesel, Zugzug, FGG, and Aaron91 would be concocting makeshift FX-322 out in a random back shed in the middle of Nowhere, Nevada because Frequency Therapeutics has no desire to improve their drug formulations?

I̶ w̶o̶u̶l̶d̶ w̶a̶t̶c̶h̶ t̶h̶i̶s̶ a̶s̶ a̶n̶ H̶B̶O̶ m̶i̶n̶i̶ s̶e̶r̶i̶e̶s̶ t̶h̶o̶u̶g̶h̶.
Click to expand...
Only if we could do it out of a 1986 Fleetwood Bounder RV in the New Mexico desert.
 
#16,937
HootOwl said:
Well yeah, no shit. What did you think I meant? That Diesel, Zugzug, FGG, and Aaron91 would be concocting makeshift FX-322 out in a random back shed in the middle of Nowhere, Nevada because Frequency Therapeutics has no desire to improve their drug formulations?

I̶ w̶o̶u̶l̶d̶ w̶a̶t̶c̶h̶ t̶h̶i̶s̶ a̶s̶ a̶n̶ H̶B̶O̶ m̶i̶n̶i̶ s̶e̶r̶i̶e̶s̶ t̶h̶o̶u̶g̶h̶.
Click to expand...
I'm planning on beating Robert Langer to improving the delivery method -- the same guy who was smarter than me during naptime when he was 2 years old than I am right now.

Don't tell me what I can and can't do. Anyone can be anything they want if they just put their mind to it. That's what momma bear has always taught me.
 
#16,940
Zugzug said:
I'm planning on beating Robert Langer to improving the delivery method -- the same guy who was smarter than me during naptime when he was 2 years old than I am right now.

Don't tell me what I can and can't do. Anyone can be anything they want if they just put their mind to it. That's what momma bear has always taught me.
Click to expand...
I believe in you Zugzug. I also found leaked footage of you and Diesel purchasing that RV.

FB9EED57-3185-4EBB-8427-357F0883B224.gif
 
#16,941
Auricle said:
In a nutshell (from the pre-print at the posted link):

"low-frequency air pressure oscillations applied to the ear canal at 4 Hz, which caused large amplitude (~ 80 µm peak-to-peak) stapes displacement"​

Unlike the other paper I posted a link to, the CP one is pretty readable.
Click to expand...
So, they blow air into your ear to make the drug go further down the cochlea?
 
#16,942
There has been soooooooo much going on here the past week and despite my best efforts I feel a bit out of the loop. Can someone please confirm that I'm up to date? As far as I can tell:

-Phase 2a was a big flop, but there is still faith in the drug. The study design was very flawed but it can at least be used for safety data.

-There are more Phase 1b studies coming out (severe hearing loss and presbycusis) that are using a single dose delivery. These are a big deal because going forward Frequency Therapeutics plans to develop this drug as a single shot treatment.

-The big hurdles for the drug as we can tell now are that the delivery needs to be improved (hard to get in that lil snail) and the "ideal" patient population needs to be determined (bad word score? Bad audiogram? Something else?).

-The stock price crashed hard with the Phase 2a news, but the company still has the backing needed to go forward.

Thanks for helping me get up to speed on this roller coaster :thankyousign:
 
#16,943
I decided to open Robinhood app and buy more FREQ stocks at these lower prices and average down, I didn't sell my losses. I think these bad Phase 2a results will be good for FX-322 in the long term because they are just working out the kinks and finding out what will not work. Now they know you can only have a single dose and future trials are likely to have better results.
 
#16,944
MrCrybaby said:
There has been soooooooo much going on here the past week and despite my best efforts I feel a bit out of the loop. Can someone please confirm that I'm up to date? As far as I can tell:

-Phase 2a was a big flop, but there is still faith in the drug. The study design was very flawed but it can at least be used for safety data.

-There are more Phase 1b studies coming out (severe hearing loss and presbycusis) that are using a single dose delivery. These are a big deal because going forward Frequency Therapeutics plans to develop this drug as a single shot treatment.

-The big hurdles for the drug as we can tell now are that the delivery needs to be improved (hard to get in that lil snail) and the "ideal" patient population needs to be determined (bad word score? Bad audiogram? Something else?).

-The stock price crashed hard with the Phase 2a news, but the company still has the backing needed to go forward.

Thanks for helping me get up to speed on this roller coaster :thankyousign:
Click to expand...
You're close enough. A lot of the rest is speculation. Everyone agrees that Phase 2a failed, but there's varying degrees of how much we think it flopped from the drug versus trial design. The two remaining Phase 1b trials will probably sway people one way or another emotionally. Either way, a Phase 2 will need to be redone with one injection.
 
#16,945
MrCrybaby said:
There has been soooooooo much going on here the past week and despite my best efforts I feel a bit out of the loop. Can someone please confirm that I'm up to date? As far as I can tell:

-Phase 2a was a big flop, but there is still faith in the drug. The study design was very flawed but it can at least be used for safety data.

-There are more Phase 1b studies coming out (severe hearing loss and presbycusis) that are using a single dose delivery. These are a big deal because going forward Frequency Therapeutics plans to develop this drug as a single shot treatment.

-The big hurdles for the drug as we can tell now are that the delivery needs to be improved (hard to get in that lil snail) and the "ideal" patient population needs to be determined (bad word score? Bad audiogram? Something else?).

-The stock price crashed hard with the Phase 2a news, but the company still has the backing needed to go forward.

Thanks for helping me get up to speed on this roller coaster :thankyousign:
Click to expand...
It depends on who you ask, but how I have looked at these results was the same as Dr. Cliff in the video that @Keith Handy posted, which is the drug seems to prefer IHCs vs OHCs.

IHCs are difficult to test for because you have to lose a lot of them before it shows up. Just like OHCs, it is a cause of tinnitus (there isn't just one structural cause) in individuals who have IHC loss (which you would only suspect if you have lost a lot of them).

I still very much believe the drug grows OHCs too (pre-clinical explant studies show this) but IHCs are preferred first pass and rapid multi-dosing produces worse results. I contend that we therefore cannot conclude what it does for OHCs without multi-dosing at much longer intervals.

Anyway, the problems Frequency Therapeutics has attributed to Phase 2a failure are:

-- Rapid multi-dosing worsening outcomes (which is not that uncommon just based on the fact that more isn't always better for efficacy, e.g., SPI-1005 did worse for efficacy at 600 mg vs 400 mg), even if they don't exactly yet know why (could be anything from overdosing to fluid overload, e.g., inducing temporary mild Meniere's type environment, interfering with signaling, multi factorial?).

-- "Inconsistencies" in word scores that Frequency Therapeutics said they found in medical records vs the baselines. I.e. people worsened their word scores to be selected.

There has been some back and forth about how many people that could possibly be, however, widespread IHC destruction much more commonly happens with severe hearing loss (there are exceptions but it's not the norm) and Frequency Therapeutics selected Phase 2a participants based on excluding people with Severe PTAs (they were put in the severe trial instead) while making low word scores a requirement. They were essentially giving a huge preference to people who would lie about their word scores inadvertently.

There is still a delivery problem below some unknown range between 6 kHz and 8 kHz based on pharmacokinetic data they had released earlier but, ironically, if they are delayed 2 years due to redoing Phase 2 with a different trial design, they may be able to piggy back a better delivery technology (Otomagnetics, less destructive surgery, etc.).

Some people think the Phase 1 and Phase 1b word score results were fraud (I don't at this point) or placebo (I don't believe the placebo effect applies to things that have historically not been possible).
 
#16,946
RingingBrother said:
I decided to open Robinhood app and buy more FREQ stocks at these lower prices and average down, I didn't sell my losses. I think these bad Phase 2a results will be good for FX-322 in the long term because they are just working out the kinks and finding out what will not work. Now they know you can only have a single dose and future trials are likely to have better results.
Click to expand...
Same. I have about €5000 on FREQ stocks (my average is around €53 or so), haven't sold a single one after the Phase 2a flop, and thinking about adding some more.
 
#16,947
Is this all like a coping mechanism for you guys? Like if it's coming, it's gonna take a long time to do so still. Being hard of hearing on top of having hyperacusis I was hyped as fuck on this but now I'm just done.
 
#16,949
Suppose the June results prove that the drug works, what are they going to do about the new Phase 2?

Will there be a new formulation of the gel or other method? An improvement compared to the single Phase 1 injection?

If it's the same injection on a larger cohort, it sucks. Phase 2 is a failure, now's a good time to go back and improve delivery, right?
 
#16,950
In the Phase 1b trials that had positive outcomes did they ever mention if there were audiogram improvements or just improvement in word scores only?
 

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