Frequency Therapeutics — Hearing Loss Regeneration

Any updates on FX-322 trials in Canada?

 

In so far as it would prevent vulnerable people getting involved in stock trades, you have a point.

Also there already is a thread on the markets right here on this site:

Stock Market Chat

Nevertheless I have come around to seeing that how the markets and the money view the research efforts can be quite a valuable thing. Recently some specialists from the hearing aid sector have come out with criticism of Frequency Therapeutics trial results. This can be viewed as a sign of success for said company. The competition actually view them as a serious threat infringing on their market share.

On a more sour note, if you take the trouble to view the historical share price of some of the other hearing research companies, boy does it make for sad reading. 30 and forty dollar share price down to a two or three dollars or less.

It certainly gives you a perspective of the efforts of science and private enterprise to tackle and solve this ailment of humanity.

 

I hope so. I tend to stay confident that it will work across the board because of the lab based evidence supporting the fact that it will work widely. Even if FX-322 isn’t the drug to provide across the board treatment, I can still see something coming along which achieves this thanks to all the good research coming along.

 

I remain hopeful that there will be a treatment for hearing loss.

What I do disagree with however is that there will be just one complete treatment to resolve hearing issues. I strongly feel that there will be individual treatments for the various conditions for two reasons.

Firstly, there could be issues if you combine multiple treatments together. Secondly, it is almost certain treatments will remain individualised so people can only treat what needs to be treated.

The promising thing is that with the relevant breakthroughs achieved in hearing medicine and all the work going into creating seemingly positive treatments, it is likely beneficial treatments will be achieved very soon.

 

At the Oppenheimer Virtual Fall Healthcare Life Sciences & MedTech Summit CEO of Frequency Therapeutics David Lucchino divulged something about the pricing of FX-322.

Cochlear implants cost sometimes $50,000 - $100,000 so FX-322 will be expensive!!

DAVID LUCCHINO:
"I’m still evolving our understanding of this as we really work in partner with the FDA to understand exactly the true, we think, impact of our therapy. So it’s hard for me to speak in any absolutes. We know that the market is absolutely substantial and the unmet clinical need is very, very high. We think that hearing aids will continue to have a real role and be a good option for patients, though we think having a therapy that can truly start to heal someone’s hearing and create a healthy cochlea, if you will, is going to be a very strong value proposition both with or without hearing aids. I think that specifics around pricing and regulatory, those really need to be managed and played out appropriately. I think that we’re aware of what hearing aids are priced at, and we’re aware of what cochlear implants are priced at, and how hearing aids are handled from a regulatory standpoint and our goal is to deliver a highly effective therapy and do it in a way where we can continue to build out a very successful company that investors will recognize for years and years to come."

 

I believe they will price their drug closer to hearing aids from this. Cochlear implants are for very severe to profound hearing loss and that's not the range they are labelling their drug for.

Hearing aids are $2,500-$5,000 per ear.

 

Hm I imagine that Frequency Therapeutics will make more money if FX-322 is more conservatively priced because it will appeal to a much bigger market of people. I feel like most people would just wind up getting hearing aids if it was $30,000-$50,000.

 

They've also consistently emphasised the size of the market they are targeting - I question the wisdom of them pricing this at a cost that would be unaffordable for the vast majority of people. I can see this being in the thousands of dollars - if it's tens of thousands (especially per ear) that would worry me to be honest. It would absolutely suck if this were released, but then not being able to afford it without saving for years.

I guess it could also depend on what sort of treatment regimen you'd have - whether you'd require multiple sessions or "maintenance" sessions or whether it's a one-and-done treatment.

 

Yeah but how much closer? If FX-322 is less than 2-3 times the price of hearing aids I'd be very surprised.

Hope I'm wrong.

 

Closer relative to a $50k cochlear implant.

It wouldn't totally surprise me if it was $10k because millions of people finance and make payments on cosmetic surgery in that price range. But I really highly doubt $30k.

 

I pray it's not that much for FX-322. $50,000+ would be insane especially if it's not covered by insurance. That would make the treatment only available for the rich and leaving everyone else out in the cold.

 

There is no way Frequency Therapeutics could charge $30,000-$50,000 for the treatment. No one would be able to afford it.

I agree with you. Frequency Therapeutics will be going after the hearing aid market and as a result will charge a similar price to that. If they don’t then they will not get the take up that they will need to not only cover their costs but also gain the hearing aid market.

The reality is that Frequency Therapeutics hasn’t even proven they can equal or better the benefit provided by hearing aids yet (although I think this is entirely probable). Therefore until Frequency Therapeutics can prove this I cannot see how they would be able to charge significantly above the cost of a hearing aid for their treatment.

The whole idea would be to try and take the hearing aid market as this would be where their biggest sales gain would come from.

I reckon that they will be going after the hearing aid market although they will be able to also add a premium product pricing component to this because FX-322 is going to perform better than a hearing aid and provide a better benefit. So let’s say if a hearing aid is priced at $3,500 then I could see FX-322 charge $4,000 if the benefit provided matched that of a hearing aid.

 

Do you think they would have payment plans in place or people could pay in installments? Also just to clarify, do you mean $10k per ear or for both ears?

 

Doctors themselves don't usually take payments, usually you'd have to go through something like Care Credit, which is like a credit card for things like health care.

It could be both ears if it's closer to the $5,000 range per ear. It's all a guess of course but I don't see it being $30k.

 

I see it being priced at the upper-end of the current pricing model for hearing aids or a little higher. A little premium is warranted when they are naturally restoring hearing. More importantly, FX-322 would be a game changer for someone with only high-frequency hearing loss. That person would likely need one set of injections, and they would be good to go. No devices or anything else needed. Revolutionary.

At the same time, we’ve heard the company continually address the large target market and demand for a drug like this. FX-322 will fill a huge need for many hearing loss sufferers. I don’t see them pricing themselves out of this market. I see this as a universal drug that many people need. I think they will charge accordingly and be heavily competitive with the hearing aid industry.

 

And usually replaced every 5 years Frequency Therapeutics won’t forget that. Luckily: neither will insurers.

 

I was happy reading all these good projections about FX-322 succeeding.

The only hurdle is being able to finance the treatment.

I’m not rich at all. But please fast forward to such a time! I’ll sell my house and get a shot. Still, it would be one of the TOP THREE best things that ever happened in my life.

 

I feel it will be no less than $10k an ear to begin with, so $20k+ overall. As a novel treatment with such massive potential there will be plenty of richer people out there to fill the available treatment places to begin with. Hell, very rich people would pay 6 digits or more for this stuff if they had to.

Hearing aids need replacing, whereas FX-322 may be a one shot deal, meaning the life cost of hearing aids is way higher than $4-5k per ear.

Hope I'm wrong, and it's as cheap as chips.

 

I reckon that this treatment could be dealt with very differently in Australia. I think that we would have to pay doctor's a fee per visit and then also pay the cost of the treatment on top of that. Most likely we would need to pay for this outright because that is how the chemists operate here.

I'm with you. Taking on the hearing aid market is definitely the best course of action for Frequency Therapeutics to take to get the best return for their treatment.

One other reason I could think of why they wouldn’t want to charge exorbitant prices is to be able to make the treatment affordable in emerging markets. If this treatment is affordable then they can make sales in places like Malaysia and Thailand where people would want the treatment but the cost would be expensive in their local economy. This would open up their market reach much more broadly.

 

Thanks for clarifying. The particulars of that aside, I was just trying to make the point that side effects typically emerge in later trials involving vastly more people vs initial trials involving very few people.

Great news! Hope they figure it out!

I know that people keep saying this in the thread, but the safety data generated in Phase I with something like 10 or 20 people with severe hearing loss doesn't prove that FX-322 is extremely safe and low risk.

Success in Phase I with a handful of less vulnerable participants enables development to move forward to Phase II with a larger net, and once again to Phase III with an even larger net. But there could be, say, a hearing damage risk that registers within a vastly expanded Phase III trial of participants with low to moderate hearing loss that would not have registered in a limited Phase I trial of participants whose hearing is already severely impaired.

My take on all of this is, so far so good! And like you, I'm extremely hopeful and eager for all of the good news to keep coming, and for all of this to happen as fast as possible.

I just don't think we can already conclude that, based on this stage of the process, it's proven to be very safe and low risk, and that the FDA is just a bunch of party poopers for not realizing that too. The whole multiphase process is to give patients a better sense of efficacy and safety when drugs do get released, and even then, there is often still much to be learned. At the same time, taking a drug before it's FDA approved involves more risk than taking it after all the data has been collected and evaluated, and only then can we more definitively say yes, very safe, low risk.

 

RECENTLY Frequency Therapeutics has positioned FX-322 as being used "in addition" with hearing aids. This is a big clue for how they may price FX-322.

They seem to have already acknowledged that it won't go deep enough into the cochlea to replace hearing aids for people that absolutely need them. So, my theory is the path for doctors may be to sell this first generation of FX-322 alongside hearing aids as a "complete" solution for their hearing loss. And for people that don't need hearing aids, where there isn't a market anyway (mild loss, or good audiogram with tinnitus/HF loss), FX-322 is the only treatment anyway.

IN THE PAST: Frequency Therapeutics has made mention of FX-322 being "accessible" to help as many people as possible. They have also touted the simplicity of FX-322 helping in affordability, and in manufacturing. It also will be distributed in a standard vial from what I can tell.

Normally: Accessible + Simple + Easy to Manufacture does not equal extremely expensive.

On Cochlear Implants: Although Lucchino mentioned in the Oppenheimer video knowing "how much" they are as a price comparator, there has never been any mention of FX-322 being used in conjunction with cochlear implants like there have been with regular hearing aids. So, I'm not sure why he said that. They also acknowledged that some patients may need to return to the ENT every 1-2 years to get new shots of FX-322.

So let's consider how the conversation with the ENT might go:

A. NEED HEARING AID: We can give you FX-322 for your high frequency loss, help with the tinnitus, help with the speech-in-noise hearing. Then, for your standard frequency loss/low word score, you can start with a less powerful, more discreet hearing aid.

B. DON'T NEED HEARING AID: Your standard audiogram looks great, you don't need a hearing aid. But you have high frequency losses and tinnitus, so we'll give you X doses of FX-322.

FOR A: The pricing most likely won't be too much higher than hearing aids, if they are positioning FX-322 to be a complementary product. Complementary products usually end up being relatively equal in price in the long run.

FOR B: The price isn't hinged to anything; since there is no treatment; potentially justifying an equal price to conventional hearing aids.

Other things to note about FX-322:

One of the two molecules that make up FX-322 is valproate sodium, a common Migraine drug; that is not expensive to manufacture today. The big variable is the proprietary molecule and the polymer delivery gel.

Economics:

Considering the millions of people that will likely demand this drug, there will be an incentive to get the drug to a price that keeps the drug flowing out the door, and the dollars back in. This is why they are looking at QOL scores in the Phase 2A. In the US, if a drug shows a QOL improvement; they'll be much more likely to reimburse.

Stockholders will also not be happy if the drug is priced so high that it cannot be made affordable by a large population. Considering Astellas is heavily involved in moving the drug in Europe and Asia, where drug price controls can be much more strict that here in the US (LOL), then it's likely the drug won't be outrageous in price.

Multi-injection reality. Frequency Therapeutics is acknowledging in the Phase 2A that patients may need multiple injections to restore hearing deeper into the cochlea. It's likely a multi-injection scenario for patients needing FX-322 in addition to standard hearing aids may drive the price down per injection.


Conclusion:

With all of this known; I think it's reasonable to expect FX-322 to be comparable in price to a set of the average high-range hearing aids for Moderate-Severe hearing loss.

My Predicted Price: $2000 per single-ear injection.

 

I must have missed the bit where they said that some people may need to return every year or two for new shots. That doesn't sound very promising.

 

I currently completely agree with you regarding the safety element of the treatment.

There is definitely a possibility that there could be adverse outcomes such as side effects which we don't see appear for quite some time. Also there may be unknown outcomes from the treatment which appear in the future.

That said, the safety trial's component is very robust and usually actually has a good chance of identifying potential problems too.

There will hopefully be more good news down the track. I can see positive outcomes coming.

 

As a hearing aid wearer I can tell you I would pay 5x if they could get rid of my hearing aids and give me back my normal hearing. Taking them in and out, cleaning them, repairing them, not having to wear them everyday. My hearing aids cost $13k.

I see FX-322 working with hearing aids and not replacing them. "We can get you 15 dB, better word clarity and for the remaining 50 dB, here is a hearing aid..."

They really need to get in the 50 dB to 60 dB improvement range in order to replace a hearing aid. Most people live with 10 dB to 20 dB hearing loss and it doesn't bother them.

I'm also curious what everyone thinks of FX-322's potential? How many dB do you think it can bring back? I'm down 110 dB at 8 kHz... This is why I don't see 10 dB as being a big deal, but I can imagine someone with a 40 dB loss thinking 10 dB will get them a little closer back to baseline.

 

In regards to FX-322 not getting deep enough, could one use the cochlear pumping method while at the ENT's office, immediately after receiving the shot? It appears the method is applying a 4 Hz sound at 8 dB to push the substance further.

The only difference I see is that FX-322 is done intratympanically, while the cochlear pumping method is done into the middle ear through the eustachian tubes.

 

Hearing loss declines in a lot of people. That's actually realistic regardless of treatment.

 

What does the rest of your audiogram look like?

 

Hair cells will continue to wear, even if regenerated. We cannot escape that part of the biology. Speaking of biology, it might be that the OHC/IHC that are regenerated are intermixed with original OHC/IHC with original wear. So, it's reasonable to predict that the original OHC/IHC will continue to wear out, thereby needing additional FX-322.

The durability isn't fully known of the new hair cells yet, either. It looks promising; but time and a ton of patients will tell. So, they probably made a conservative short-term estimate.

Also, consider the highest users of FX-322 - people in jobs/environment at a risk of daily high noise exposure. They'll probably be annual consumers of the stuff.

Also, it could be that they want to keep the faith with ENTs/Audiologists that are used to the annual visit model with hearing aids.

 

One thing that I would note from your comment is that while the CEO David Lucchino has indicated that there is a likelihood some people will still need a hearing aid after FX-322 due to it not going deep enough into the cochlea, I would still not rule out that they would not possibly work out a way to get the medicine deeper in the future.

The information which Frequency Therapeutics has released has always actually ended up being ultra conservative because they simply cannot risk falling afoul of the FDA rules. Therefore I equally wouldn't be surprised if Frequency Therapeutics was also being very cautious in commenting about the benefits of FX-322.

I refer back to where Frequency Therapeutics stated something along the lines that they didn't think FX-322 was going to be the medicine which would actually end up providing full regrowth, but that there are some pretty clever drug delivery guys so who actually knows what may end up happening. This tells me that the need to use FX-322 with hearing aids may not actually end up being a long term thing.

There could be every chance that I am wrong, however this gives me the impression that Frequency Therapeutics might actually go down the path of getting FX-322 out ASAP and work improving the benefit it can provide later on. This way Frequency Therapeutics can start assisting patients ASAP and work with improving things later.

 

As it relates to safety, we do know that even up to 2 years after receiving FX-322 in the Phase 1/2, there were no reports of any adverse reactions long-term, and that many of the patients that saw a benefit retained that benefit.

As far as the Phase 2A is concerned with safety: Many of the early participants, and likely those that began before March 2019 are now either completed or nearly completed with the trial. In June, they mentioned they were half-way recruited. So, we know that roughly 45 patients have probably exited the trial without any adverse/serious reactions. Also, the FDA seems pretty keen to halt a trial when anything unexpected happens; and since they just finished recruiting, it seems unlikely.

So, practically speaking we have data on the safety of FX-322 reaching as far back as 2 years, and publicly somewhere between 50 and 60 patients have received the drug since the original Phase 1 safety trial.

Still no issued warnings re: safety.