Frequency Therapeutics — Hearing Loss Regeneration

Not usually to be honest. You can check it yourself. You just need a connection to a Bloomberg terminal and very low latency.

If you look at stock prices after some big news, the price almost always moves right on the second the news is published and no sooner.

Of course there are some instances where insiders trade early but it doesn't usually happen or is just not noticeable.

 

I think the original IP that they started the company with is actually licensed to them by MIT. Any subsequent IP would be sold to someone else. So, not gone.

 

It may or may not need a Phase 3. Depends on if Phase 2b meets endpoints, and FDA says a Phase 3 is needed. By now, almost 300 patients have received FX-322. That's enough safety and adverse effect data for the FDA to decide if one is needed.

Note: They're still on-track for a Breakthrough Therapy Designation. If that were to be applied by the FDA, they'll likely skip the Phase 3.

 

I do agree that even if the effects were slight (even this would be an improvement), they should push it to the market to keep things going forward which of course depends on the FDA and study results.

I bet there are a lot of other drugs in the market that have very minor effects, if any at all, and also drugs that are not even safe!

 

Frequency Therapeutics Announces Topline Results for its Phase 2b Study of FX-322 for the Treatment of Sensorineural Hearing Loss

"FX-322-208 Study Fails to Meet Primary Endpoint, Showing No Significant Separation in Speech Perception Between FX-322 and Placebo

Company Will Now Focus on Advancing its Program in Remyelination for Multiple Sclerosis (MS)"​

FX-345 is also discontinued.

 

The news is out. Looks like it's bad.

"The study, which enrolled 142 people with either sudden or noise-induced sensorineural hearing loss, failed to achieve its primary efficacy endpoint of an improvement in speech perception. Data showed no statistically meaningful difference at day 90 between those administered FX-322 versus those receiving placebo in the proportion of individuals that demonstrated an improvement in speech perception. There were also no measurable improvements observed in any of the study’s secondary endpoints."​

 

So this means it is pretty much the end of the hearing regeneration for the company.

"The Company will immediately reduce headcount as part of an overall restructuring, downsizing personnel by approximately 55 percent."​

 

Stay strong everybody, this is horrible news.

 

Very bad to read about this, but we must face the facts. Frequency Therapeutics already removed everything about "hearing" from their website. Maybe this makes it easier to accept and focus our hopes on something new.

 

What will you focus your hopes on now?

 

@Zugzug was right all along.

 

How sad. But a lot to be learned from this episode.

 

Nothing specific, but there is more research going on out there. I know, everything is years away, but still going on.

 

This has been an absolute nightmare with nothing but letdowns.

I wish they gave more details about the clinical trial. Otonomy also just said their clinical trial failed and that’s it.

Well, hopefully Dr. Susan Shore helps people with tinnitus.

The long-term noxacusis people are pretty much screwed. I’ll be living in a room the rest of my life.

Is it really this hard to restore hearing? Why do we deserve this? For every other disease there’s hope and treatments. This ear stuff, hahahah, we’re completely doomed. And still all we have is TRT, CBT, positive thinking, and gaslighting from mild cases.

You guys all know how it is. Every person here who has it bad has been gaslighted in some way. All of you have definitely heard mild tinnitus people say "omg, my tinnitus is so severe I have to mask it with a fan!", or "my hyperacusis is so severe that I have to wear earplugs at the club!", or "I have severe hyperacusis but I can shoot guns!" Then these positivity preachers say how we need to push through it and expose to sound because it helps them. It’s an absolute joke on every level. Every single person here feels the same.

Tinnitus and hyperacusis will never have good treatment because it’s taken as a joke by everybody; even people who have it mildly but who say they have it severe. We will never have anything because of the people who apparently have severe hyperacusis, who still shoot guns, and who suggest not to wear earplugs because it makes the hyperacusis worse, and to expose to sound and retrain your brain. Hahahah. That’s all we get. Failed clinical trials, and no hope.

I’ve been a part of this community for a very long time. Everybody here should be worried. I have always been positive saying there’s a lot out there, lots of research, lots of hope, but really, it has all failed.

Now I have to say nobody is going to save us. There’s not going to be some magic injection that restores hearing. We will only get lucky if powerful people with enough funding try to fix these issues. It’s not looking too good folks. I hope Dr. Shore’s device helps. My tinnitus is pretty bad but not at an unlivable level yet, so I can wait, but I hope it helps all you guys really struggling from tinnitus. I’m just baffled how there’s so much traffic on these websites; there has to be very wealthy people looking to make a difference to fund more research. There has to be somebody with hundreds of millions of dollars who is affected by tinnitus or hyperacusis. I’m ranting, I know, but you all feel my pain, of hopelessness and despair.

 

Around 2 weeks ago, David Lucchino, the CEO of Frequency Therapeutics, made 2 retweets which I thought were odd and with hindsight seem even stranger.

Retweet #1:

Retweet #2:

I wonder, at the time he made these, did he know the results or have an idea of what they might be? It seems like he's choosing the path of "failing test" by shutting down FX-345 too. Maybe he did these right before he was given the results, and had mapped out paths to take upon failure or success. Still, these were strange tweet to make at the time. I think a lot of people read these tweets an indicator that things would be positive rather than negative.

 

Well, perhaps we can stop the hysteria now.

As a scientist, I always said I saw next to nothing in the results, describing it as limping around from failure to pass to failure.

20,000 comments on what I always considered fool's gold. Yes, I wanted it to succeed but the case was never there.

Slick PR is all they ever had. Thank god we are put out of our misery with this hyperbole nonsense!

 

Brian, I have read your posts and truly feel sorry for you. But I feel like noxacusis (I joined the club last Friday unfortunately, I'm still devastated about it) will be solved earlier than complete removal of tinnitus.

Pain management is an extremely important research area in big pharma. The 'holy grail' of Nav1.7 modulators to permanently switch off pain is extensively researched and has so much more momentum than noxacusis. It wouldn't cure your condition but it would certainly take the pain away. That research isn't taking place in the ear field but of course in the (neuropathic) pain management area. You are well educated in the topic, but switching off tinnitus or stopping hearing loss seems to be more difficult than stopping pain.

On topic: I don't want to throw salt on open wounds, but this failure was unfortunately to be expected.

 

But it's understandable that, for many of us, it provided some hope at least.

Now, we definitely know.

 

@tomytl, yes, but I don't like suffering people given false hope on the back of no solid foundation. The results from previous clinical trials didn't look good 'to me' at any stage. I don't know what others saw.

 

Sad news, but it was expected with the BS they fabricated about the first trial with the "faulty" design.

 

This followed the same footsteps as Otonomy, multiple dosing one week after the next, whereas Otonomy tripled the amount of gel/BDNF. I still wish they'd release the best responders and give insight into their diet, exercise routine, and other 'odd' tidbits of their lifestyle, like if they blindfolded themselves for a week (there was a Tinnitus Talk thread on this).

Bad news after bad news - I feel like there will be a big recession coming up and we won't find a treatment until the next decade to say the least. And a cure (i.e. total hearing restoration and/or complete tinnitus silencing) not in our lifetimes.

 

I genuinely don't believe that. I think there are a few people on here who should be paid much more attention to though. People like @Juan for instance, who has very good real world time-served firsthand knowledge of how a condition like hyperacusis, and by implication noxacusis, can change for a person over the years. Swapping quality of hearing for a little less pain for example. And finding our way.

I'm a lot politer than you (and most here) when it comes to things like the above so please excuse my language. I'm sick to fucking death of the gaslighting from mild cases.

I've said it many times before, but our whole approach to tinnitus, including how we interact online has to be stratified. I've seen too many cases now where some catastrophising new member with tinnitus 'since yesterday' spams the forum, screeches and rants, even joins clinical trials, screeches and rants about that, but then suddenly disappears having 'made peace' with their condition. There was even one individual who claimed praying to god had helped.

It drives me fucking nuts. So much so that I spend less time here, and don't tend to interact with people unless they have at least 2 years experience of tinnitus under their belt. Most new members won't be here within 12-24 months.

Hamid Djalilian received a very handsome sum and spoke about it on here. But my attempt to further research his work only returns stories about some online sound app à la the same old shite that every man and his dog is trying to upload to a mobile phone. I've been able to find practically nothing about his, wire in the cochlear, tinnitus device.

Tinnitus research is in a very strange place unfortunately. Perhaps it's always been like this, it's just that the Internet has highlighted the glaring issue. For example, I'm originally from an engineering background. Not withstanding the fact FX-322 was not a tinnitus drug, the thought of assembling a group of engineers to solve a problem they can't actually define because they can't actually measure it, is so ludicrous it almost defies words. But that's where we still are with tinnitus research; much of it playing on people's desperation.

I know I'm the broken record of this site, but in my view we should halt all curative tinnitus research until the puzzle of objective tinnitus measurement has not only been solved, but can be used at clinical point of care. Then and only then, when we can hold the feet of these so-called researchers to the fire and demand objective results, should we move forward with trying to solve the rest of the puzzle. Until that time we continue to go round in circles.

Rant over. Sorry, Brian. Obviously none of this was directed at you.

 

The idea behind FX-322, and FX-345 for that matter, is good in concept, as many things are.

However, I think if we're being honest, the fact that it's based on the idea of birds being able to regenerate stem cells and mammals not being able to, and trying to tackle the difference between the two by blocking or intercepting whatever inhibits the regeneration isn't the most reliable jump-off point.

Gene Therapy, targeting the specific genes that either block hair cell regeneration or activating ones that kick off hair cell regeneration makes a lot more sense to me.

Unfortunately, FX-322 and FX-345 are dead and this approach will hopefully not waste time and money any longer.

 

Going to make my final point about this whole sorry affair. For fuck's sake PLEASE stop conflating trading stocks, ticker price and ticks of movement, from the academic chitchat doing the rounds on here. The two are NOT the same.

Unless you're willing to throw money down the shitter, PLEASE at least try and learn to read a price chart. Tinnitus research has screwed so many of us over the years, don't let the tinnitus stock market screw us too.

PS - sorry about the language but I became extremely concerned the moment people on here began punting buying choices this time 2 years ago just before the previous monumental crash. THAT'S how long I've been holding onto this outburst. Apologies again.

 

Is this about a better treatment/cure, or financial gain?

The CDC demands it!

 

@Chad Lawton, are you selling now? What a shame!!!

 

@Brian Newman, I'm sorry and I understand. I just saw two outcomes and always tried to temper expectations down a bit. For me it was either today's outcome or a marginal signal of significance that would have no chance in a large Phase 3 group, just prolonging the agony. It's better this way, as it doesn't work. They even narrowed the parameters so much that it wouldn't have helped most anyway.

So, let's focus on The Shore Lab, the two trials for tinnitus completing this year, and in the next 5-10 years the electrical stimulation/implants technology.

Be restrained and don't emotionally (or financially) invest outside our remit with good prior evidence.

Temper down the enthusiasm for these epilepsy trials too. It's only theory and the companies seem uninterested in trialling them for tinnitus.

Some of us are very vulnerable and I'm glad this was put to the sword finally.

 

They released this news earlier than I expected.

Probably better it failed now rather than dragging on and failing at Phase 3.

Disappointing news all the same. At least it may help future researchers avoid this type of treatment.

Well well well, look at that. Bots win out yet again. My idea would have actually worked very well if someone had the technical know how.

We'll get the next one.

Its only use is a tax write-off at this stage, in my opinion.

 

Yeah, the problem is I’ve tried many things now, and everything I try along with pain meds change the way your brain senses pain. It doesn’t get to the root of the problem. And what I’ve noticed with my case, my ears only get worse when my brain is hiding the pain from all the stuff I’m taking. Then when the drug or whatever I’m taking stops working to full effect and my body gets used to it, the permanently worse pain creeps up more and more until I have to take something else. That is why noxacusis is so misunderstood because no matter what the drug is, the pain I have will always get more severe than the benefits of the drug I’m taking. That’s the case with every single pain drug in existence. All they do is mask the pain until your body gets used to the drug or the condition worsens. The only way people get relief from trigeminal neuralgia and other painful conditions is surgery. That is why all these people with chronic pain never get better because their specific conditions don’t have treatment, just drugs to mask the pain.

Then if you want to take into account 90% of medications can cause more hearing damage, that’s even more of a crap show. So yeah, you’re right if they can permanently switch off pain, then I’m cured. That’s if they can 100% switch it off which won’t happen for another 10-20 years anyways.

Sorry you just joined the club. This stuff is not fun. I hate to break it to you but trust me, there is way more hope for tinnitus than noxacusis. If you go to doctors, they will know what it is at least, nobody has heard of noxacusis. Hyperacusis is so rare, let alone noxacusis. Tinnitus has way more clinical trials and research. There are 2 million people with severe tinnitus in the US alone. Hyperacusis is 1 in 50,000 - that’s including the mild people. 90 percent of hyperacusis people can live somewhat decent lives. Noxacusis is more like 1 in 200,000 and most people improve to live a better life. 10 percent of those people never get better, and have to remain home most of the time. I’ve been on every single page that ever existed on the internet, I’ve read every success story, every horror story. I consider myself more knowledgeable than any doctor when it comes to noxacusis. There’s a few people on these forums that share this knowledge with me.

I have lived and experienced every single level of hearing conditions. I’ve experienced mild, moderate and severe loudness hyperacusis. I’ve experienced mild, moderate, and severe tinnitus. I’ve experienced mild through severe distortions, or dysacusis. I’ve experienced mild through catastrophic noxacusis. Remember I’m not some new case who’s panicking and saying there’s no hope, we’re screwed. I’m the “worst” case ever. I’m not saying you’re one of those new people because you seem optimistic. My point is I’ve been around the block with all this and I know everything down to the final detail about these hearing conditions.

Now hopefully you will improve enough to where you can live a semi normal life because that seems that’s what happens to most people. You will probably suffer for a few years, maybe less, then forget all about this (hopefully). So truly, very few people can say they’ve experienced the true horrors of long-term severe noxacusis. I don’t consider people who had it very bad and who improved within a year severe cases. Duration is a big factor when it comes to this condition. Yeah, being home, away from everything for a few months, maybe a year or two, sucks horribly, but there are people who spend years at home and only get worse. Some people I’ve talked to have tried every single drug with no help. They have been living in a soundproof from for 10 years because the pain is so crippling and they never improve.

So if I try to compare noxacusis to tinnitus, it’d be arrogant of me to say noxacusis is worse. After all this website is called Tinnitus Talk. Way more people have tinnitus, so for me to say noxacusis is worse is just spitting in everybody’s face here. But trust me, I’ve talked to enough people to truly understand these conditions and how the worst cases in the world are affected. The truth is catastrophic tinnitus and catastrophic pain hyperacusis are both unlivable. They are both from Satan himself. Only two things that scare me in this world. Noxacusis and tinnitus. The thing is, like I’ve said, I’ve talked to the worst cases in the world of both conditions, and what makes the worst tinnitus cases, are people whose tinnitus permanently spikes to everything, leaving them in an endless pit of worsening. This forces them to stay home and avoid everything, seclude from society and give up their life. I find this is extremely rare for tinnitus to be that bad but there are quite a few people who I’ve met on here who experience that. I bet there’s people with such bad tinnitus it would make both of us lose our minds, I’m sure of it. I mean sirens in your ears 24/7 is an absolute nightmare.

I won’t get any more into how bad tinnitus can be because you get the point, but even most severe tinnitus cases are still somewhat living a life, unless they’re at that level I was mentioning. Even though they are being tortured every second of the day, they do their best to make ends meet, provide for their families and keep on going. For this I have incredible respect for. And I’m not saying it’s easy because severe tinnitus is the second worst thing in the world. So even listening to this hell, most people at least are still somewhat living a life. They can go to the grocery store, be with family, exercise, go to the beach, go to restaurants. Being able to go out and do things like that help incredibly with dealing with tinnitus because it keeps you somewhat distracted. Before I got noxacusis, my distortions and beeping in my right ear was catastrophic and was extremely loud. It drove me nuts, I didn’t sleep, I went insane. But being able to see friends and family, being able to go to work and go to the gym - even half assed because I was so tired - kept me alive.

Now having to deal with that tinnitus, but also being trapped in a room unable to leave much at all, never seeing my friends, unable to work, cannot exercise much because it makes the pain worse, I cannot distract myself from any of this because I’m forced to sit in a room away from everything and everybody, listening to my tinnitus blaring while in severe pain that never stops. That’s a true nightmare. So if my pain stopped, I would definitely chose this over severe tinnitus because at least you can get a break. Severe tinnitus never stops. But never being able to be around noise ever again is something most people will never understand.

So trust me, I’m not trying to scare you because if you’re smart, you will get better, but there is no hope for noxacusis. Everybody should be terrified. So like you said, if they find a way to turn off pain signals forever, that would be ideal, but even then I read that if they do that, a person never being able to feel pain again is problematic. There’s people who live with the inability to feel pain and they always hurt themselves by accident. So if it comes down to a doctor choosing to permanently numb my pain, or forcing me to deal with a “little” ear pain, they won’t do it, just like they don’t deafen me, or cut my middle ear bones to cause hearing loss because they don’t care and don’t understand.

So yes, there will be tinnitus treatments, guaranteed, before noxacusis treatments.

Yeah, I agree, I’m sick of the mild cases. I remember when I first got this, people would talk to me, then if I said I just got tinnitus, they would shake me off or say I will probably get better. Now I understand why lol.

I don’t consider anybody under two years a severe case, because anything could still happen. I’m not saying people aren’t suffering of course. But yeah, people cannot give advice if they get better magically. Because I’m pretty sure most of us here are past that magically healing phase since we all have had tinnitus or hyperacus for 5+ years.

I do think we need a way to see inside a live cochlea in a human. That’s imperative, not some garbage hearing test which show’s absolutely nothing.

Yeah, it’s too bad how this community gets nothing but disappointment.

 

I have to once again think something fishy has gone on here. How in the hell was that CBS piece done? Frequency Therapeutics pushed it out to get a bump up in the share price. Those that were in the know cashed in before the results were published and the company was done. They must have known it did nothing when the CBS piece aired.

Think positive. The drug doesn't work, yet that chap who was deaf for a couple of years in the CBS piece got his hearing back, so let's just hope we win the lottery with that one and one day wake up cured

Experimental, early-stage drug aims to restore...