Frequency Therapeutics — FX-345

Well, this thread can be shelved. FX-322 and FX-345 are both done.

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

"The Company will now discontinue the FX-322 development program. In addition, while dosing of FX-345, a second program to treat SNHL, has been completed in the initial safety cohort of an ongoing Phase 1b trial, that development program will also be discontinued. The Company will now focus its resources to advance its remyelination in MS program into the clinic."
 
The cancelling of FX-345 was the only thing that shocked me with today's press release. I had kind of expected FX-322 to fail again. The data from the previous studies wasn't great, and was in fact it was weaker than Otonomy's OTO-413 data, so I felt there was a good chance it would either fail, or if it did succeed, the benefits would be very minor.

The fact that they're shuttering FX-345 too means they've lost complete faith in their hearing tech. It makes me wonder what the problem with these drugs was. Are they not regenerating human hair cells? Are the hair cells not connecting up properly? Is the drug not being delivered properly? Maybe there's another piece to the hearing puzzle that we're not aware of yet?
 
I was banking more on FX-345 working, FX-322 seemed like a long shot. Hopefully their MS drug works, there's way too many people who suffer from it. Then maybe they can return to hearing restoration with a load of cash to do so.
 
I wonder why they dropped it so easily
I think it was the same formulation, just in a different solution to permeate further. Basically it's the same active ingredients in both and if it doesn't work, who cares how far into the cochlear it reaches.
 
I think it was the same formulation, just in a different solution to permeate further. Basically it's the same active ingredients in both and if it doesn't work, who cares how far into the cochlear it reaches.
It was not. The regular FX-322 is 88 mg/ml sodium valproate (HDACi), 3.1 mg/ml CHIR99021 (GSK3i), 5% w/v DMSO (solvent for CHIR) and 16.1% w/v Pluronic P407 (gelling agent). FX-345 is likely (based on very limited info they released) the same 88 mg/ml sodium valproate, 5% w/v DMSO and 16.1% w/v Pluronic P407, but the GSK3i is different. I suspect it is LY2090314, or its derivative. It is about 20 times more potent than CHIR.

They could have reached further down the cochlea with CHIR, but they had some limiting factors. For example, if one adds more sodium valproate to the solution, the formulation gels above body temp, instead of at. One way to counteract that is by purifying the polymer (P407), i.e., removing the low molecular weight strands, thereby letting the regular long strands gel at a lower temperature. With this method they could reach 130 mg/ml of sodium valproate concentrations, possibly enough to reach down to 7-8 kHz instead of about 10 kHz with regular FX-322. CHIR also had a solubility limit of around 5.1 mg/ml, so that was another problem, hence the new GSK3i. Another problem with higher sodium valproate concentrations is the high tonicity of the solution (lots of salt ions). The regular FX-322 is hypertonic as-is, and that can actually lead to hearing loss when applied to the cochlea, in my opinion.
 
They've already dosed several people with FX-345 and they're not going to collect any data. How much more money does it take for a few hearing tests on a handful of people? Was that really going to break the bank?
 
Frequency Therapeutics made millions through pump-and-dump schemes. Everyone does it, but it's still a scumbag move. I bet their summer houses, BMWs, and Christmas dinners are top-notch.

It still irks me knowing it led to a flop, and they were shilling to inflate the share prices.

Crooks.
 
Many of us with damaged ears can get an acoustic trauma from noises barely north of 100 dB. Mine was a deaf cat screeching 5 feet away from me.
A 110 dB hit to already compromised ears is quite a blow. I'm still dealing with the aftermath of a 112 dB shock from about two weeks ago. Both of my ears were exposed to the same sound. The ear that's less damaged seems to be fine, but my left ear, which already suffers from hyperacusis and tinnitus, fared much worse. Hearing tests so far haven't shown any changes, but I still have residual distortion that I'm really hoping will eventually go away.

It amazes me how easily some people's ears can be damaged. It's equally surprising that many professional musicians can have 40- to 50-year careers and experience no significant hearing issues, despite playing every day.
 
It amazes me how easily some people's ears can be damaged. It's equally surprising that many professional musicians can have 40- to 50-year careers and experience no significant hearing issues, despite playing every day.
Maybe their ears are damaged, but they don't have symptoms like tinnitus. My grandpa served in the artillery, and he's half-deaf because of it. Oddly, he doesn't have tinnitus. The brain is too complicated to fully understand.
 
Maybe their ears are damaged, but they don't have symptoms like tinnitus. My grandpa served in the artillery, and he's half-deaf because of it. Oddly, he doesn't have tinnitus. The brain is too complicated to fully understand.
Yep, you are right. How he doesn't have loads of tinnitus spinning around his head is beyond me!
 
I can't believe what happened with Frequency Therapeutics. They made bold claims about curing hearing loss, with huge articles and pages dedicated to their work. I can't believe they went out of business after such a promising story. I think their treatment was effective, but it seems they were more focused on money. The medical industry, in general, doesn't seem to care about the public's health. If they really cared, they wouldn't have given up so easily in the first place. They would have fought harder to make the treatment work and been more transparent about it.

To be honest, it's not just them; the entire medical industry, including companies worldwide, even nonprofits, don't prioritize the general public's health. Nonprofits still need to keep the lights on and avoid going out of business, so they, too, face financial pressures. Because of this greed, we may never see a true cure for hearing loss. It feels like they're more concerned about profit than finding real solutions.

Hearing loss should be taken much more seriously. It's expected that by 2030, 2 billion people will suffer from hearing loss, compared to the current 1 billion. With 7 to 8 billion people on the planet, that's a health crisis. People with hearing loss are struggling, and many say how hard it is. Hearing aids are not a cure. They don't restore normal hearing and are useless if you're completely deaf since they only amplify the hearing you have left. Cochlear implants aren't a cure either. They sound robotic, even the newer models from companies like Med-El, and auditory brainstem implants are not the answer either.

What we need is a real treatment or cure, something like pills or injections that can restore hearing and normal life. This problem needs to be taken seriously. But why does it seem that everything requires funding? Why does money have to slow everything down? The need for funding, regulations like the FDA, and the endless greed of pharma companies all seem to get in the way of real progress. At this point, it feels like no one, no pharma company, no government, cares about people's health. Everything seems to be about money, especially in a capitalist society.

The FDA, being part of the federal government, reflects the same lack of care. It's not just in the U.S.; other countries face the same issues. We need to be better people and build a better society. I wish pharmaceutical companies, the FDA, and governments acted in the public's best interest. Don't people expect pharma companies to do good? Sure, it's evil to profit off of people's suffering, but we can't expect them to work for free. Still, we can expect them to be compassionate and work to get cures out there. It's the best thing they could do for society, rather than all the current nonsense.

At this point, there's no cure for hearing loss, not because it's impossible to regenerate hair cells or restore hearing, but because of capitalism. The world is ruled by money, and we live in a capitalist society where profit matters more than people.
 
I've ruined my eyesight following the twists and turns of FX-322, so please excuse me for not having gone through this entire thread on FX-whatever. ☕

But I noticed that their stock — if that's any indication — has fallen from around $90 in April/May down to $31 today.

What made them so confident it would work back in those heady days?

Was it because they could grow hair cells in a petri dish or a test tube? Or perhaps in a human cochlea discarded after a cochlear implant?

Did they believe they could cure chronic tinnitus (not the acute or early onset type) in rats, guinea pigs, horses, or other mammals?

Or were they hoping to alleviate hearing loss altogether?
 
At this point, there's no cure for hearing loss, not because it's impossible to regenerate hair cells or restore hearing, but because of capitalism. The world is ruled by money, and we live in a capitalist society where profit matters more than people.
This statement has been made many times: money is the cure for tinnitus and hearing loss.

The problem lies in the fact that hair cells, for reasons still unknown, do not regenerate, repair, or replace themselves in mammals.

If a treatment is going to be developed that causes hair cells to regrow and fully function again, I believe it will come through the aid of a medical technology that does not yet exist.

Until then, no matter how much money is poured into research, a cure is unlikely for a long time. Probably decades at a minimum.
 
This statement has been made many times: money is the cure for tinnitus and hearing loss.

The problem lies in the fact that hair cells, for reasons still unknown, do not regenerate, repair, or replace themselves in mammals.

If a treatment is going to be developed that causes hair cells to regrow and fully function again, I believe it will come through the aid of a medical technology that does not yet exist.

Until then, no matter how much money is poured into research, a cure is unlikely for a long time. Probably decades at a minimum.
If we don't do something now, things will remain the same. We need an incentive for a cure for hearing loss and tinnitus. There is so little research on ears, which are one of the most neglected organs in medical research. I don't believe it takes this long to test treatments; it's likely the FDA rules and regulations that slow down the process. The cure could still be effective and brought to market much faster. Companies exist to make money, so we can't expect them to develop cures out of the kindness of their hearts. For example, FX-345 was developed, and then nothing was said about it; they just gave up. It's frustrating that hearing loss isn't being taken seriously. We need a cure now.

There is no way it should take decades to find a cure for hearing loss. The COVID-19 vaccine was developed in less than a year, and yet it feels like treatments are more profitable than cures. There is barely any incentive to create a cure. Baldness, for example, is easy to cure, but the medical industry doesn't teach doctors about food and lifestyle changes that could help. Instead, they deny facts because it's all about money. Where is the incentive to help people if there is more profit in treatments?

I believe 90% of conditions that are said to be incurable could be cured with proper research and effort, especially if the focus was on a cure instead of profits and FDA regulations. There's no way testing should take 12 years. Take baldness, for example. There are known ways to address it by eating certain foods or applying treatments. The truth is that the medical industry isn't focused on cures; they're driven by profits. FX-322 and FX-345 could have worked, but we'll never know because the medical industry is not transparent. We can't trust them to act in our best interests.

Capitalism is the main reason why healthcare exists in its current form, and you can't trust the medical industry to act out of kindness. We need to create incentives for a cure now, or there won't be one. It's ridiculous that funding is always needed. Why can't they just focus on the cure instead of all the bureaucracy and regulations? It's clear that the government and the FDA care more about money than about public health. The medical industry doesn't prioritize the health of the public.

If FDA rules and regulations were less strict, there would be more effective drugs and more innovation. Companies would also be more careful to avoid being sued, which would ensure safety. The current system protects companies from lawsuits rather than focusing on the public's safety.

I've been thinking about alternatives to capitalism because, right now, profits are prioritized over people. Companies are investing more in treatments than cures. I'm not exaggerating when I say this is the truth: there's so little research on hearing loss and sensorineural hearing loss. The media doesn't help either, because news outlets like Fox News and CNN are businesses too. They exaggerate stories to bring in more viewers, which means we can't even trust the news.

This lack of focus on cures doesn't just apply to hearing loss. It's the same for cancer, rabies, baldness, infections, and so many other conditions. It doesn't take 12 years to cure baldness when the solution is so simple. Why do medical devices take so long to reach the market if they are safe? There's a lot of suspicious behavior in the medical industry, from pharmaceutical companies to governments around the world. It's obvious they aren't even trying to hide it anymore.

Big Pharma conspiracy theories are often labeled as just that, conspiracies, but the truth is that there's evidence for them. For example, it's more profitable to make light bulbs that burn out after a few months than to make ones that last forever. The same principle applies to medicine. These industries are driven by profits, and they don't even try to hide it. I hope you now understand what I mean. We need to raise awareness so that the general public knows what's going on. The medical industry truly doesn't care about public health. Hearing loss has become a health crisis, and it's being slowed down by FDA regulations and a focus on profits.

I wish the public knew more about this. I wish we lived in a utopia where cures were prioritized. But right now, there's no cure for hearing loss, cancer, rabies, and other conditions because it's not profitable. You can't even trust universities, churches, or charities anymore because they're all businesses looking for money. The government doesn't care either.

You need to take me seriously because this is the truth. I'm being honest.
 
@Mohamed2009, this is why Tinnitus Quest was set up. Have you joined the mailing list and donated? Patients will need to invest their own money and time. People without tinnitus or hearing loss won't raise funds because they don't care.
Just for the sake of completeness, we all contribute to medical research. The government collects revenue through duties on things like beer, gas (petrol), income taxes, capital gains, and probate taxes. Then, a government agency or committee decides how much of those funds will be allocated to various areas, such as cancer research, Alzheimer's research, hearing and tinnitus research, and so on.

Our job is to make sure tinnitus research gets the attention it deserves—a capital "T," if you will. After all, we're paying for it too.
 
Just for the sake of completeness, we all contribute to medical research. The government collects revenue through duties on things like beer, gas (petrol), income taxes, capital gains, and probate taxes. Then, a government agency or committee decides how much of those funds will be allocated to various areas, such as cancer research, Alzheimer's research, hearing and tinnitus research, and so on.

Our job is to make sure tinnitus research gets the attention it deserves—a capital "T," if you will. After all, we're paying for it too.
I agree, @Joeseph Stope.
 
We should all collectively join forces and sue David Lucchino for the false hype and misleading claims. There have only been two trials against him, and the court keeps siding with him. We need to create more noise. Such a greedy Ashkenazi Italian. I had high hopes for FX-322 and lost significant money while this guy and his associates profited from our naivety.
 
We should all collectively join forces and sue David Lucchino for the false hype and misleading claims. There have only been two trials against him, and the court keeps siding with him. We need to create more noise. Such a greedy Ashkenazi Italian. I had high hopes for FX-322 and lost significant money while this guy and his associates profited from our naivety.
We need to let it go. Unfortunately, those who questioned the initial results and choice of outcome measures as "fishy" were shouted down. In the future, we need to ensure that people can freely challenge such claims and point out potential issues to those who may be overly trusting.

Any company that uses speech-in-noise tests or relies on mainstream media to hype their research is a big red flag.
 
We need to let it go. Unfortunately, those who questioned the initial results and choice of outcome measures as "fishy" were shouted down. In the future, we need to ensure that people can freely challenge such claims and point out potential issues to those who may be overly trusting.

Any company that uses speech-in-noise tests or relies on mainstream media to hype their research is a big red flag.
Is it a class-action suit that's being considered? I know a lot of people here jumped in during the boom period.

My opinion? I'd leave it to the American lawyers. Many of these cases are settled out of court, and the legal environment in the U.S. is entirely different. Just keep in mind that every lawyer there is looking for a client, often on a no-win, no-fee basis. That sounds fair to me, though; full disclosure: I'm just an observer on the sidelines.
 

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