Frequency Therapeutics — Hearing Loss Regeneration

[Rb86]

Have we got any evidence that restoring hearing will reduce tinnitus? Why then hearing aids don't help?

I've seen it help for some. Time will tell.

 

[Mr Mister]

The testing and research is outsourced and operates under their guidance. So there could be hundreds of scientists employed by them, working in third party labs.

Coordinating hundreds of scientists, tendering and negotiating a global out-licensing deal at the same time takes a lot of resources as well.

 

[Rb86]

Coordinating hundreds of scientists, tendering and negotiating a global out-licensing deal at the same time takes a lot of resources as well.

It does, however, 14 people is enough. You'd be surprised the multi multi million dollar deals that are secured with only a few head people.

Trust, there were many involved in the research, but they have real traction now. These are all positive. Let them do their job. This is a new medicine, but bringing medicine to the market is the same process.

 

[ChrisBoyMonkey]

Could someone summarize the 139 pages of this thread to a few key points, what is FX-322 about?

What I understand and please, correct me If I'm wrong:
- FX-322 is a hearing restoration/regeneration drug.
- They just completed Phase I trial and this will be followed by a Phase II in the fourth quarter of 2019.
- They're about to announce "something" (results of Phase 1? anything else?) in the next weeks.
- They just got license agreement with Astella to both speed up the trials and possible commercialization.

I have mainly the following questions:
1. Is this just a single injection/shot directly into the inner ear?
2. Did they share any successes before? Any compliance/benefit numbers so far?
3. Some details, like how long does it take to see the results/improvements, is there any risk of worsening and other negative consequences, observations?
4. This might be suitable for people with measurable hearing loss, what about people with no hearing loss (clearly with hidden hearing loss?)
5. We don't know If hearing restoration/improvement helps to reduce/suppress tinnitus so far, right?
Is there a reason to be excited about this? Many previous experiments/attempts failed, right?
Noone from Trial here on the forum to share some experiences, right?

Many thanks for attempt to summarize this for me and potential new people into this!

1. Only one was used for the phase 1 trial. They plan to multi-dose in phase 2.
2. They haven't shared exact numbers but they have stated they were already seeing efficacy results.
3. They were evaluated at initial follow up, 2 weeks after injection, and monitored for 3 months.
4. They do not specifically mention hidden hearing loss.
5. Hearing aids do help quite some people with hearing loss in the frequencies hearing aids cover. Although not yet confirmed, the general consensus among the science community is that it likely will be of help.

 

[tarmaced]

1. Is this just a single injection/shot directly into the inner ear?

They will be looking at multi-dose trial. I guess the then preferred dosage scheme is dependant on results.

2. Did they share any successes before? Any compliance/benefit numbers so far?

No results in humans detailing regain of hearing yet. They have however said it will happen in a conference this year.

3. Some details, like how long does it take to see the results/improvements, is there any risk of worsening and other negative consequences, observations?

I don't think we have this info yet. I agree this is a must-know, we do however know that this is a risky area - when injected generally this stuff is cancerous (turn blue and die type cancerous apparently [source anyone?] ).

4. This might be suitable for people with measurable hearing loss, what about people with no hearing loss (clearly with hidden hearing loss?)

Sorry, I can't say. I know that the re-integration of nerve cells has been described as a 'miracle' (so there may be some impact on the audio nervous system IMO) , but sorry, can't comment.

5. We don't know If hearing restoration/improvement helps to reduce/suppress tinnitus so far, right?
Is there a reason to be excited about this? Many previous experiments/attempts failed, right?

I think there is good reason to be exited for this as part of a large swathe of emerging treatments.

No-one from Trial here on the forum to share some experiences, right?

As little as 15 people could have had this drug and wouldn't have know that they were not on a placebo (one individual dropped out of the study). The world is a big place and individuals on here may not consider just how little some participate in the online communities.

Edit: If anyone can improve upon this poor attempt please do so!

 

[Enclave]

This article was written based off an interview that was done yesterday, but they specifically state in the article that Frequency Therapeutics is headed for a Phase IIa later this year. Looks like Phase II is going to be broken up into two parts, and not just a single blanket Phase II trial.

https://www.genengnews.com/news/ast...peutics-partner-to-develop-hearing-loss-drug/

 

[Ivkopivko]

Many thanks for the summary @ChrisBoyMonkey and @tarmaced, I believe it is great summary and will be appreciated by many interested in this!

 

[Earing]

How much will they charge? There is a genetic eye disorder that has a stem cell cure. It costs $850,000 USD for the treatment. Not sure if it is one eye or both.

 

[d'Wooluf]

they will need to compete with hearing aids...

As a hearing aid user, I have to say that they really aren't much competition. I hope that real competition comes sooner rather than later so that we can afford treatment. Something about the naked greed in all of this gets my leftist goat.

 

[Misticvega]

How much will they charge? There is a genetic eye disorder that has a stem cell cure. It costs $850,000 USD for the treatment. Not sure if it is one eye or both.

Buy some ALPMY. If it works, sell in a couple years, pay for operation.

 

[tarmaced]

As a hearing aid user, I have to say that they really aren't much competition. I hope that real competition comes sooner rather than later so that we can afford treatment. Something about the naked greed in all of this gets my leftist goat.

I to be honest fail to spot the 'naked greed'.

Buy some ALPMY. If it works, sell in a couple years, pay for operation.

Look at it this way - if it is competing with HAs then the better it works the higher the price will be! This will be produced in mass if it does work, lowering the costs. The drug you reference is for a rare condition. It is a one time treatment for 1000-2000 people this generation in the USA. That is way off from mass production. That is a very small market.

Meanwhile at a minimum 37/1000 people in USA have trouble with hearing. That's 12 million people. If you can get one tenth of them to pay at 8,500 GBP shot (I pulled this number from the air btw) that's 10343 million GBP. The vast majority of the costs are from research and development and if successful this drug will make more profit priced low.

PS: I used America since it is a well developed economy that I could get stats for easier.

 

[d'Wooluf]

I to be honest fail to spot the 'naked greed'.

Yeah. My 'naked greed' may be your 'the capitalist system at work'. It's probably just my general mindset at the moment. It would be nice though- seeing as how most of the research was done at publicly funded institutions - if someone ever mentioned at least the possibility of trying to keep treatment affordable. It would suck big time if after all these years of waiting we couldn't afford the treatment when it arrives.

 

[Earing]

If it does work then it should be free in Canada by the time it is available. Our govt is threatening to cover all drug costs for all Canadians.

 

[ChrisBoyMonkey]

If it does work then it should be free in Canada by the time it is available. Our govt is threatening to cover all drug costs for all Canadians.

Threatening? You mean offering?

 

[Rb86]

If it does work then it should be free in Canada by the time it is available. Our govt is threatening to cover all drug costs for all Canadians.

You Canadians are alright with me, I don't care what anyone says!

 

[Flamingo1]

As a hearing aid user, I have to say that they really aren't much competition. I hope that real competition comes sooner rather than later so that we can afford treatment. Something about the naked greed in all of this gets my leftist goat.

You think they'd be doing all of this for free!?? How many advances and breakthroughs have come out of totally leftist countries? The idea that Frequency Therapeutics would invest millions of dollars to produce a produce a drug to sell for pennies on the dollar is not a sustainable business model. Besides, greed is what makes capitalism work. The more you charge, the less you sell.

 

[d'Wooluf]

You think they'd be doing all of this for free!??

I've rabbited on about this before, so I'll make it brief. I'm not fixated on it and I can't change it.

They didn't do "all of this". Other scientists have made sizable contributions over a long time. FX are building on what went before. Prior to the formation of FX, the work they did do was paid for by their universities. So definitely not for free. If you want an example of scientists who achieve great things for mankind without expecting billions in return, there are a couple in my town. Discovered the h. pylori bacteria that causes stomach ulcers amongst other things. Experimented on themselves actually.

Other scientists collaborate (look up the Hearing Health Foundation). These guys apparently don't. So, I'll be cheering them on but I don't like them particularly. And I'm sure they don't particularly care!

The idea that Frequency Therapeutics would invest millions of dollars to produce a produce a drug to sell for pennies on the dollar is not a sustainable business model

I haven't looked up the exact figures, but what they've spent is some portion of their financing up to now. What's that? 50-60 million? If everything goes according to plan, they're going to get 620 million from their new partners plus royalties on each treatment. And that's before you consider their domestic market. That's serious moolah.

 

[Flamingo1]

If everything goes according to plan, they're going to get 620 million from their new partners plus royalties on each treatment. And that's before you consider their domestic market. That's serious moolah.

I appreciate your opinion, @d'Wooluf. However, if money is what motivates Frequency Therapeutics to bring their product to market, I'm all for it!

 

[just1morething]

I appreciate your opinion, @d'Wooluf. However, if money is what motivates Frequency Therapeutics to bring their product to market, I'm all for it!

I would suppose it's demand first and having the technology to meet the demand (if it even works) Money could be the overall driving factor. With Otonomy I believe the founder had ear issues himself (I believe he had Meniere's and tinnitus)

When are they predicting FX-322 will be available to the public? I thought it was several years. It will be headline news anyway. Some of us could have wrinkles in our ass by then.

 

[tarmaced]

On average, it takes just under 8 years for a drug to go from Phase I of human clinical trials to market launch in the US. The same figures for Phase II and Phase III drugs are 6.1 and 3.7 years respectively. More specifically, an average drug spends 1.7 years in Phase I, 2.4 years in Phase II, and 3.7 years in Phase III before launch.

Source: Adams, C., & Brantner, V. V. (2003). New Drug Development: Estimating Entry from Human Clinical Trials. SSRN Electronic Journal.

This is also highly dependant on the field. I read recently that a major blocker for cancer-related trials was finding people to do the trials. This shouldn't be an issue with hearing.

I think its also worth pointing out that phase 1 was quick compared to the above. I still expect phase 2 to be longer and would expect multiple doses to obviously make it longer, but I have hope

 

[just1morething]

 

[tarmaced]

I have a question in turn. Do we know of any lab results that support multi-dose performance? I know that it must exist... but I want to read it for hope lol.

 

[ChrisBoyMonkey]

It's probably safe to say in about 3-5 years as they are moving at a very fast pace. Yes, in capitalism money is usually the motivation.

Even so, the best way to make this money it is finding the optimal price/demand ratio given the target consumer. Since many people will need it, most of them probably not rich (except for maybe the musician segment) then we can expect it to be at a reasonable price.

 

[ChrisBoyMonkey]

I have a question in turn. Do we know of any lab results that support multi-dose performance? I know that it must exist... but I want to read it for hope lol.

They haven't started the multi-dose trial yet. They have said to they plan to start it in the last quarter of this year, so it will likely start very soon.

 

[tarmaced]

They haven't started the multi-dose trial yet. They have said to they plan to start it in the last quarter of this year, so it will likely start very soon.

I couldn't recall if we had seen reference to multidose treatment in rats for example, that would support the upcoming trial.

 

[ChrisBoyMonkey]

I couldn't recall if we had seen reference to multidose treatment in rats for example, that would support the upcoming trial.

That would require some digging, I'm not sure if they have said it has been done yet. I've only found this:

https://www.businesswire.com/news/h...Revolutionary-Small-molecule-Approach-Restore

 

[tarmaced]

That would require some digging, I'm not sure if they have said it has been done yet. I've only found this:

https://www.businesswire.com/news/h...Revolutionary-Small-molecule-Approach-Restore

That sounds crazy promising. I'll look for a paper later "Clonal Expansion of Lgr5-Positive Cells from Mammalian Cochlea and High-Purity Generation of Sensory Hair Cells,"

EDIT: I have the above mentioned paper now. Got it through means that publishing companies don't tend to like, but feel free to PM me if you want it.

 

[Daniel Lion]

Love you FX-322.

Hope you can help some of us.
Some is realistic.

620 million on top of 60 million domestically and then royalties... I find really comforting to read. It keeps me optimistic. These are the numbers that represent something revolutionary.

 

[BrStan@]

I still can't understand. Can someone please post a link to the clinical trial or a study clearly proving that improving hearing will reduce tinnitus? It looks we hope for something that we wish to be true.

P!ease don't bother with quotes if you can't show proof.

 

[BrStan@]

Hearing aids don't cover the highest frequencies (tinnitus is usually a very high frequency "beeeee"). So your brain keeps trying to compensate for the missing sounds.

So according to you tinnitus is heard only above 8kHz. And no below. Is that what you are trying to say? What is the source of this information? I will be very interested in seeing it. P!ease post it here.