Frequency Therapeutics — Hearing Loss Regeneration

@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...

 

Yea, I’m selling most of my shares. I was not anticipating them discontinuing both FX-322 and FX-345 at the same time. They went from having 3 shots on goal to now only having 1. I took a huge financial loss but also just sad from a tinnitus sufferer’s perspective.

 

So are FX-322 and FX-345 over for good, or can we hope for some more research?

 

Me too. I'm out like $40k. Such a shame. I'm FAR more upset about the potential of the drug too. Money comes and goes...

 

I got into stocks because I believed in the research by this company and hoped to get some silver (or gold) lining out of this trauma. Everything happens for a reason, right?

I cannot imagine a more effective learning experience when it comes to how to read stocks / how to invest and understand the risks involved.

For that I am humbled and grateful. I will not repeat this mistake.

 

100% dead and never coming back.

As they said themselves, this failure will help future research by showing what not to do. That's about it. It's bad but not completely useless, even if that use is minuscule.

Research is extremely slow.

 

I dumped it all, 20,200 shares. Funny how that works. Just a month ago I was up like $65,000, that's biotech for you. Gone now, two losses at once, hearing recovery/tinnitus and a big chunk of money...

 

My sympathy and commiseration all around.

Taking a long and a broad view, it might indicate that the scientists need to increase the knowledge base and gain an understanding of what's happening in the cochlea and brain or dorsal cochlear nucleus.

 

Oh wow, -80.7379%, so sorry.

I think top execs must have jumped ship a long time ago, is that not insider trading?

 

To be fair, individual stock picking in general is a losing game however you look at it. It’s not exclusive to the ‘tinnitus’ stock market.

 

Nah, there are rules about them trading. I'm pretty sure they need to make all their trades public.

Sometimes they get their spouse to actually make the trades though, like Nancy Pelosi lmao.

 

I know what I am asking is only speculation, but as a scientist, what's your best guess for when we might get a reasonably effective tinnitus treatment?

 

@xerpes, when I say scientist, I mean science graduate and college lecturer. I'm no big wig but the results did not impress me.

Dr. Shore's device in December 2023 - effective for at least 1/3rd, maybe a bit more than that.

Pimozide and SAGE-547, depending on results, possibly in 2024 - and as both are already on the market, they would be repurposed for tinnitus.

Electrical/Extracochlear stimulations and DBS type stuff in 2030.

I always leave well alone any clinical trials that are not for tinnitus, like XEN1011/BHV-7000, preventative/acute stuff like SP-1005 and Hough Ear Institute's pill. They are theories and we can get carried away by magical thinking.

If anything happens to help some people off-label, brilliant, but I can never buy into a company thinking they have a treatment for a symptom with no treatment, but decide they will trial it for other things first.

 

Why do you think that is?

 

I definitely want to see more in-depth results of this trial. Did the success rate need to be at least 40% to pass the trial? I wonder if they were anywhere close to this number?

 

Two months ago Frequency Therapeutics did a story with CBS that featured a former trial patient saying they got "84%" of their hearing back. It's now less than 2 months later and they've shut down all of their hearing programs and scrubbed their website of most of their hearing drug related info. The company name doesn't even make sense anymore.

I have to wonder: what possessed them to make that CBS report? What purpose did it serve? The only thing that came out of it was a run on their stock (I didn't hold any, but I have held some in the past). I mentioned this elsewhere and was mocked, but it really seems suspect that they did media before they had legit results backing up their drugs.

 

CBS ran the report. Not Frequency Therapeutics.

 

Well that's the end of that journey. I came back onto Tinnitus Talk in 2018 after my left ear went from moderate-severe to severe-profound hearing loss, and FX-322 was still in its early days of being announced.

I think the lessons I learnt are as follows:

1. Joining online tinnitus communities as an echo chamber or to read the repeated phrase "I hope" with regards to an unproven unreleased drug is not a wise use of time nor is it a good distraction from tinnitus which is hard enough to distract from as it is, if not practically impossible, so why make that task even more difficult.

2. Real scientists are in a lab. Message board "scientists" read too much research papers and medical journals. The human mind thinks deep and the hypotheses are endless - there are more things to life than reading what TinnitusLord3435's "scientific" conclusion is.

3. People go to extreme lengths to create reason to believe in something that gives them hope for the outcome they desire. There was some serious copium at times.

Something may come for us or it may not. Live life as however much you possibly can (in terms of how much this condition allows you) - with the notion things may improve, it may stay the same or it may become worse. Any breakthroughs in our lifetime to improve the situation by this point, to me, is a bonus, not an expectation. Probably the best way I can keep on going.

I am sorry we go through this. I wish you all the best.

 

Feeling for all of you who invested so much hope. Cochlear implant for me I think. All the best.

 

Because no one can ever pick winning stocks consistently unless they’re Warren Buffet or Michael Price. It’s extremely difficult to do for a sustained period of time (net of fees and taxes). People can score big one year, and then lose all those gains the next year or so. If people do cash out, I guaranteed most of them get sucked back in and reinvest their earnings in another stock because picking a stock that soars is an intense and addictive high.

Same thing applies to market timing. No can ever master it consistently. If it were possible, then everyone would be rich. Even slightly beating the Index year after year is vanishingly difficult. Only a handful of investors have been able to outpace it over time. These people become superstars (Warren Buffet).

My take: Anytime you buy or sell a stock, no matter how careful your research and sound you’re thinking, there is someone on the other side of that trade just as convinced you’re wrong.

It is why indexing is better. Best to track the performance of a market index instead. You make better returns long term. It’s less stressful and costs are low. More than half people who do stock picking or active management will never outperform an index in a 15-year span.

 

Good riddance. Joke's on you Frequency Therapeutics. I never believed in this crap anyways I still remember what happened in 2020.

Anyway, cheer up guys! There's more new discoveries on the horizon. We literally just mapped out the inner ear and another group identified a molecular switch for hearing development. it ain't over till the fat lady sings.

We got this.

 

I'm not going to lie, this seriously bummed me out and I even shed a few tears. And no other pharmas are going to have anything in the pipeline for another 4 or 5 years. I'm just really sad, there is no hope, not only for tinnitus but for hearing restoration in general.

The Dr. Shore device may work to relieve tinnitus but it won't restore hearing.

 

So, no-one feeling a little angry at this point? Feeling that they've been led down the garden path by one of the greatest hype machines the world has ever seen?

We're close to 20,000 posts by the way.

 

I for sure am. I was prepared to accept the failure of FX-322 but for the company to decide to scratch the entire FX-345 program in one fell swoop as well, especially when no patients even made it to the 90 day testing window based on their first dosed patient in December, absolutely pisses me off as an investor and a tinnitus sufferer.

You’ve got Lucchino going on CBS news pumping the company when they had absolutely nothing to base it on.

I don’t blame anyone that brings a lawsuit against them now. Management seems more interested in preserving their jobs and milking their half a million a year salaries for a couple more years by cutting half their workforce rather than doing what’s best for the company.

 

Angry and sad. What’s shocking is discontinuing FX-345 as well which I wasn’t expecting. FX-322 must have not done too well for them to discontinue FX-345 but they should mention why FX-345 was discontinued.

We won’t really know until they release the presentation of the FX-322 Phase 2a trial. Would they even still release it at this stage?

 

0% anger. 100% despair.