Frequency Therapeutics — FX-345

There's a lot more funding going to other incurable diseases that actually kill people, like cancer.

I know hearing loss is terrible but at least it's not killing people.

You are a tad optimistic on your profit predictions. Frequency Therapeutics and others have provided guesstimates on what the market is worth. The fact that hearing loss is a growing issue is the main point they put into their pitch decks.

 

Disagree. The WHO state at least 1.5 billion people worldwide have hearing loss or issues. It’s probably a lot higher in reality, but we’ll take that at face value.

If you could treat hearing loss right now for those people, the profits would not only be in the tens or hundreds of billions over the course of a few years. The sham that is Lenire costs thousands per person and doesn’t even seem to work.

And again I disagree. Hearing loss does kill people. People are driven to suicide every day by tinnitus.

 

Also, if someone can't hear someone call out "Watch out!" they could also end up losing their life. Very concerning if they work in a dangerous environment.

Not only that, but the fact that hearing loss can lead to dementia is a bit alarming.

 

Do we know why some people didn't respond as well? Was it because of their advanced age? Did they have long-term hearing loss?

 

How many people die like this compared to all the people that die of cancer, what do you think?

I get it that you guys want a treatment but you need to be realistic and take facts as they are.

 

What are the realistic facts, that you are talking about? Let's take a view from the economic perspective:

Companies want to make money in the first place. Investor/company decisions don't exclusively depend on how much people die from a disease. The hearing regeneration market is a big financial opportunity with a lot of unmet needs. The cancer market is saturated - many big companies are already targeting that disease and are working on various treatments.

 

When there is a lot of money to be made, there are even more people eager to make it. I'm glad someone else sees it, nearly everyone will experience hearing loss in their life. It's a never ending demand. Elderly and veterans being a hot market for these drugs is a given; though I also see many ENTs using this in clinic after a round of Prednisone even if the hearing loss was not substantial just to further cover their bases.

All this of course banks on not only the efficacy, but the safety of the drug. If they are right about their formulation, I suspect many forum users will be enjoying their new beach houses, and condos.

 

There is not trillions of dollars of profits to be made on anything in the entire world.

If there was great potential, then there would be more investment. The people investing do it as their job. They do know what they are doing.

With how every single hearing regeneration company has already failed, it's not the most attractive investment.

The hearing aid market alone is only $7.5b. There are probably less people with tinnitus than with hearing aids. Or less people with severe tinnitus anyway.

 

I doubt what you are saying. The veterans' compensation for tinnitus in the US alone is higher then your stated hearing aid market value. Why are you so pessimistic? People need hope, that's the only thing we got with this terrible affliction.

 

No, sorry. It's not that simple. Without giving too much away (in reference to my other posts) I am a development scientist for a medical company. I can't tell you how many projects with absolutely astronomical market value do not get fully started because "this is a new area, so... rather than invest £50M of our own money in research costs to show proof of principal, why don't we wait until someone else figures out the basics and then build our own treatment off of that research. That means we don't risk our 50M upfront." Investors do not look at people's suffering, they do not look at "what could this be worth in 10 years" - they look at "what's a proven, safe, semi-decent return for my clients' money."

And 'treating cancer' isn't a thing in of itself. There are approximately 200 types of cancer. Most of which will require independent, specific and/or specialised treatment pathways. It's not a case of "this tablet cures testicular cancer, so it'll cure brain cancer too." Money given to cancer research labs isn't taking money away from hearing loss research labs. It's that hearing loss research labs are not getting the funding at all.

Compared to diseases like cancer, the funding being given to hearing loss research is so tiny it's not even on the map (believe me... I know). Without the huge funding cancer has received, the treatment would be far worse than what's available today. With how many hundreds of billions (possible more?) have been invested in cancer globally, you'd think we'd have a cure, no? No, cancer treatment has remained unchanged for some time now. Does that means it's a dead end and an unattractive investment since there's no cure-all-cancer-pill yet? Of course not.

Non relevant comparison. In the UK alone, 6 million+ people require hearing aids, yet only 2 million are prescribed them through choice. Either social issues (I don't want a hearing aid) or denial. 1 in 6 UK adults have hearing loss. 1 in 10 have a degree of tinnitus. Many people are told their hearing is bad, but not bad enough to benefit from a hearing aid, so aren't even given the option.

If somebody told you "you can have these hearing aids for the rest of your life", most people would say no thank you.

If somebody told you "we'll schedule an appointment, a small injection in your ear and within a few months you'll have regained x% of your hearing", most people would say sign me up.

I see where you're coming from, but in the next decade or so, hearing loss occurrence is going to reach critical mass; how many kids these days do you see with headphones permanently in? But it seems only a few companies are forward thinking or willing to take the risk in development the cornerstone technology that will cure hearing loss. And I hope when successful, their researchers and investors reap the rewards.

 

Unfortunately it will take investment from sources passionate or impacted by hearing loss and tinnitus to find even a fraction of investment needed to find a 'cure'.

Otonomy was co-founded by a millionaire who was impacted by Meniere's. It didn't succeed of course after 14 years, but the initial launch of the company was based upon someone impacted, rather than an investment house looking for a ROI for its clients - although this came later through a series of fund rounds.

It needs someone(s) with incredibly deep pockets who have been terribly afflicted or impacted by this as a serious condition who has the capital necessary to launch one or more companies in search of an ultimate cure.

Even 10% wealth of all celebrities who say they 'suffer' with tinnitus would raise a substantial sum towards research, but it isn't coming.

Hopefully Dr. Susan Shore's device, and maybe a breakthrough in neuromodulation and medication by Prof. Dirk De Ridder - or maybe XEN1101 will show equal promise for tinnitus sufferers - will pave a way to narrow down the parameters and allow investments in to startups focusing on a more targeted solution.

If not - we always have Mr Musk - who, tbh, is kind of my outside bet here.

 

It is the cost that prevents most people from purchasing hearing aids.

 

Hearing aids are free in the UK.

 

I have to say that hearing aids are more expensive than ever but the government should definitely step in to make sure everyone has access to at least a midranger to help people get their life back to some normalcy.

 

Has FREQ ever applied for a DoD grant for hearing loss treatments?

 

They received a grant from the DoD prior to the FX-322 Phase 1/2.

 

Only $7.5b lmao. BILLION.

 

I know this might have been discussed over and over again in the threads, but how much would this kind of treatment possibly cost if it reaches the market? 100 dollars? 1000 dollars? More? I think the small molecules are pretty cheap to make but maybe the injection procedure costs more?

 

If it gets the FDA approval, I think that insurance would cover it. Just a guess, but just like any other drug.

 

Health care systems have differences. For example, here in Finland we have a public health care system. Eager to see if FX-322 & FX-345 reaches the market, when and how it will be administered in Europe.

 

It would depend if Finland's health regulator authorises its use, FDA approval has no meaning for Europe. The first hurdle is EU approval, then each country can decide to use it if they wish.

 

Yes, I guess so. Actually I have not thought about this earlier. Found a link about FDA's office in Europe. Not sure yet what does it mean. Maybe someone wiser could enlighten me about it. Surely many of us here are from Europe, not just US. I would be amazed if EU would not approve the product(s) if proven to be working since it would be first and one of a kind.

FDA - Europe Office

We can only speculate. I think that if FX-345 works better in a broader spectrum inside the cochlea covering the most frequencies, we could possibly see way better responses in all patients (theoretically). But time will tell.

Has anyone seen anything about the participants' age and how each age group responded?

The only thing should matter is that FX-322 works and is put out in the market, start making money, continue with FX-345 and enhance the product even further. Also, with the income flowing, it should open more opportunities to start studying and developing even more and better products faster! Think about the opportunities!

Of course we hope for good news soon to make all of this possible. I wonder how fast they would proceed with FX-345 if the upcoming results of FX-322 are not that assuring.

Sorry for the long post!

 

The FDA have offices in Europe to audit European companies that have approved products sold in the US.

Generally, the FDA can be quite difficult when approving a new product, so if the FDA approves it, European regulators like BSI tend to also approve it.

 

Dexamethasone injections cost $300 near me and that's for the uninsured. I figure the FX-322 procedure's cost would be similar though the amount of gel being injected is far less (0.2 milliliters I believe is the dose they are still using, Dexamethasone injections are 1.0 ml a pop).

I'm trying to find the exact CPT code for a middle ear injection, but could only find so far 69081 which is surgical procedures of the inner ear which is far more expensive.

 

I think $300 is cheap considering what the injection could potentially achieve.

 

It'll depend on how successful (if it is) and how effective it is.

If it's 60% effective at reducing tinnitus by 40%, then expect to pay $ X.

If it's 100% effective at reducing tinnitus by 100% then expect to pay five or ten times $ X.

 

If it's 100% effective, I wouldn't think twice about spending $100k on it. I'd much rather spend $5k though.

 

Absolutely. If someone told me I could permanently hear true silence again, I’d pay what they ask.

 

The injection procedure is very simple, routine and quick. In and out of the office in like 45 minutes. They talk about this in their presentations as being a benefit regarding how the practice is done in a lot of ENT departments.

 

It's not about just the procedure cost or how much it costs to make, but also recouping all the R&D etc.

If you think about how much LASIK costs, then I would be very surprised if regenerating hearing would be much cheaper than LASIK.