Frequency Therapeutics — Hearing Loss Regeneration

[FGG]

Seems crazy that it's automatically another year of trials regardless of the nature of the reformulation... I mean if the drug itself is the same what gives? Sigh.

Part of me is wondering if since we already have another year of trials (phase 2b) to go for FX-322, if Frequency won't go ahead and do the safety trial for the new formula at the same time they are doing phase 2b for the current one.

They did hire those specialists after all, and if it's true that other treatments already penetrate deep into the cochlea, it seems like it wouldn't take them long to formulate the new delivery vehicle.

Also when might we expect approval for OTO-413? I checked that thread but it didn't seem super clear.

It's sadly necessary, otherwise a drug company could say something is now "extended release" (for instance) to immediately prop up sales and give the CEO and the board a nice bonus before anyone notices. That would obviously be bad for a company's long term reputation but it would definitely happen occasionally without oversight.

But the trial is significantly shorter because there isn't much additional data the FDA needs because like you said the drug is essentially the same.

 

[HootOwl]

Seems crazy that it's automatically another year of trials regardless of the nature of the reformulation... I mean if the drug itself is the same what gives? Sigh.

Part of me is wondering if since we already have another year of trials (phase 2b) to go for FX-322, if Frequency won't go ahead and do the safety trial for the new formula at the same time they are doing phase 2b for the current one.

They did hire those specialists after all, and if it's true that other treatments already penetrate deep into the cochlea, it seems like it wouldn't take them long to formulate the new delivery vehicle.

Also when might we expect approval for OTO-413? I checked that thread but it didn't seem super clear.

That's actually a good question. I don't know know if they can get a "head start" so to speak on the new formulation trials even while being in clinical trials for their initial IND.

@FGG maybe we could add this to the questions list? Frequency might have already rolled this by the FDA.

But if all of our theorizing is true and they are positioning themselves to skip phase 3, we can think of that extra year to reformulate as being where that phase 3 would have been. At least, I'm holding out hope that's the case so those of who need to hit the low frequencies for both OHC and IHC won't have too much of an extra wait.

OTO-413 is completing their phase 1/2 by the end of this year. As long as they don't decide on a 2b - which they might, no one knows - and move directly to phase 3 they could be out by the time Frequency's first drug iteration hits the market.

You also possibly have the Hough Pill coming out by then too. Their partner Oblato seems to be doing some strategic re-positioning by pivoting their drug designation from "bomb blast pill" to "cochlear implant trauma reducer". Some members (and myself included) believe this is to get it approved quicker and easier.

 

[AtlasFainted]

It's sadly necessary, otherwise a drug company could say something is now "extended release" (for instance) to immediately prop up sales and give the CEO and the board a nice bonus before anyone notices. That would obviously be bad for a company's long term reputation but it would definitely happen occasionally without oversight.

But the trial is significantly shorter because there isn't much additional data the FDA needs because like you said the drug is essentially the same.

Thanks for the reply! I disagree about it being necessary though: as you said it would be bad for the company's reputation & likely wouldn't happen very often.

If they straight up lie to people and their product sucks, their sales will tank and investors will bail. Personally I think basic economic rules (incentive, competiton, consequences) provide enough oversight here. If it's safe let the market decide... people need this and other drugs/formulations sooner than later.

But obviously I am being too opinionated! FDA policy is FDA policy and that likely won't change soon enough to affect FX-322 either way.

 

[AtlasFainted]

That's actually a good question. I don't know know if they can get a "head start" so to speak on the new formulation trials even while being in clinical trials for their initial IND.

@FGG maybe we could add this to the questions list? Frequency might have already rolled this by the FDA.

But if all of our theorizing is true and they are positioning themselves to skip phase 3, we can think of that extra year to reformulate as being where that phase 3 would have been. At least, I'm holding out hope that's the case so those of who need to hit the low frequencies for both OHC and IHC won't have too much of an extra wait.

OTO-413 is completing their phase 1/2 by the end of this year. As long as they don't decide on a 2b - which they might, no one knows - and move directly to phase 3 they could be out by the time Frequency's first drug iteration hits the market.

You also possibly have the Hough Pill coming out by then too. Their partner Oblato seems to be doing some strategic re-positioning by pivoting their drug designation from "bomb blast pill" to "cochlear implant trauma reducer". Some members (and myself included) believe this is to get it approved quicker and easier.

Wow, thanks for the info about OTO-413 & the Hough Pill!

Makes me excited that we could potentially be getting these treatments 1-2 years from now. I thought the Hough Pill in particular was still 5 years away.

I'm really hoping Frequency might announce FDA trials starting for the new vehicle at the same time they announce phase 2b, if there are no rules prohibiting it.

It seems far-fetched, but then again it doesn't. Why wouldn't you want FX-322 to restore the full hearing range ASAP? It would be a powerful move for Frequency & their investors/partners.

As a side note, it amazes me that the federal government isn't more interested in making hearing recovery a priority as far as funding/accelerating the release of these treatments. Even if we assume all politicians are evil egomaniacs, fixing one of the #1 ailments that torments veterans would work wonders for the poll numbers.

 

[Lucifer]

Thanks for the reply! I disagree about it being necessary though: as you said it would be bad for the company's reputation & likely wouldn't happen very often.

If they straight up lie to people and their product sucks, their sales will tank and investors will bail. Personally I think basic economic rules (incentive, competiton, consequences) provide enough oversight here. If it's safe let the market decide... people need this and other drugs/formulations sooner than later.

But obviously I am being too opinionated! FDA policy is FDA policy and that likely won't change soon enough to affect FX-322 either way.

@AtlasFainted I think the FDA are just worried about the risks of using a new formulation to get the drug delivered to the round window.

If they can get FX-322 out asap using the current method then a year after it comes out they could use the new method which is better. I just want the drug to come out asap whatever the method they are using.

 

[Skity]

Seems crazy that it's automatically another year of trials regardless of the nature of the reformulation... I mean if the drug itself is the same what gives? Sigh.

Part of me is wondering if since we already have another year of trials (phase 2b) to go for FX-322, if Frequency won't go ahead and do the safety trial for the new formula at the same time they are doing phase 2b for the current one.

They did hire those specialists after all, and if it's true that other treatments already penetrate deep into the cochlea, it seems like it wouldn't take them long to formulate the new delivery vehicle.

Also when might we expect approval for OTO-413? I checked that thread but it didn't seem super clear.

The FDA isn't always logical, you can look at another aspect, why require placebo control for hearing loss treatment? as if you're magically going to hear frequencies you physically can't after swallowing a sham..

 

[AtlasFainted]

@AtlasFainted I think the FDA are just worried about the risks of using a new formulation to get the drug delivered to the round window.

If they can get FX-322 out asap using the current method then a year after it comes out they could use the new method which is better. I just want the drug to come out asap whatever the method they are using.

Yeah best case scenario they will run trials in parallel & get the drug and the new vehicle approved around the same time. My knowledge of FDA procedures is limited though, there might be some red tape keeping this from happening. Or maybe it just isn't Frequency's plan.

From what @FGG is saying it seems like the trial for the new formula would take about a year and it is more about efficacy than anything. In which case I would argue let the market be the judge (if the delivery vehicle is presumed safe). But I am no one of great influence/importance when it comes to the FDA's actions. *shrugs*

 

[MrCrybaby]

The FDA isn't always logical, you can look at another aspect, why require placebo control for hearing loss treatment? as if you're magically going to hear frequencies you physically can't after swallowing a sham..

I actually think it's important to have a placebo control. I have seen some absolutely shameful studies (on other topics) that use the lack of control to make silly claims.

 

[Lucifer]

@AtlasFainted I think the FDA are just worried about the risks of using a new formulation to get the drug delivered to the round window.

If they can get FX-322 out asap using the current method then a year after it comes out they could use the new method which is better. I just want the drug to come out asap whatever the method they are using.

@AtlasFainted it also could be too much work for Frequency Therapeutics to handle the current method of drug delivery and a new method of drug delivery at the same time while still working on Phase 2a clinical trials.

 

[AtlasFainted]

The FDA isn't always logical, you can look at another aspect, why require placebo control for hearing loss treatment? as if you're magically going to hear frequencies you physically can't after swallowing a sham..

As far as placebo goes I do think it's necessary because your test patients could have some natural improvement over time, or the vehicle/method of administration may be a factor in audiogram changes.

You want to know what the drug does & what the vehicle/needle itself does. Also enviromental factors may have an effect on on test results, so it's nice to have another group that didn't recieve the drug (while all other variables are the same) to compare against...

But yeah you're preaching to the choir. Safety is one thing, but I don't understand why the FDA is involved with efficacy at all to be honest. It does more harm than good. The market could figure out efficacy/quality the same way they do in every other industry.

I could dig deeper into my rationale here but I don't want to drive this thread off topic! I'm pretty passionate about this so feel free to message me... I might make an independent thread about the FDA just so I can list my arguments freely lol.

 

[Lucifer]

This is what I've been thinking recently. What would come out first, FX-322 or a coronavirus cure or do you think both will come out at the same time?

 

[aot]

This is what I've been thinking recently. What would come out first, FX-322 or a coronavirus cure or do you think both will come out at the same time?

Coronavirus cure, or at least a vaccine. As awful as hearing loss, tinnitus and hyperacusis are, Coronovirus has the international spotlight and has killed over 30,000 in the U.S alone.

That being said, the sooner COVID-19 is taken care off, the sooner industry will start up again.

 

[Lucifer]

Coronavirus cure, or at least a vaccine. As awful as hearing loss, tinnitus and hyperacusis are, Coronovirus has the international spotlight and has killed over 30,000 in the U.S alone.

That being said, the sooner COVID-19 is taken care off, the sooner industry will start up again.

Could be possible for FX-322 to come out around the same time as the coronavirus cure/vaccine.

 

[AtlasFainted]

Coronavirus cure, or at least a vaccine. As awful as hearing loss, tinnitus and hyperacusis are, Coronovirus has the international spotlight and has killed over 30,000 in the U.S alone.

That being said, the sooner COVID-19 is taken care off, the sooner industry will start up again.

I wonder how many of the estimated 30 million Americans with hearing loss & tinnitus we lose per year due to suicide or the mental disorders/disabilities that are brought on by the hearing issues.

I'm so grateful that Frequency is still moving ahead...

 

[Jack V]

Coronavirus cure, or at least a vaccine. As awful as hearing loss, tinnitus and hyperacusis are, Coronovirus has the international spotlight and has killed over 30,000 in the U.S alone.

That being said, the sooner COVID-19 is taken care off, the sooner industry will start up again.

*80,000

 

[Pink Noise]

[QUOTE="Daniel Lion, post: 524836, member: 33923"I had a funny thought yesterday of getting a shot and then going to an amusement park and getting on a ride similar to a centrifuge. You could create an awesome vacuum and suck the drug deep into the cochlea. Weird... I know.[/QUOTE]
That's ace!!! Made me laugh out loud!!!

 

[Turgy]

FX-322 is developed for people with hearing loss.

What effect does FX-322 have on people with tinnitus? Does anyone know?

 

[Lucifer]

I wonder how many of the estimated 30 million Americans with hearing loss & tinnitus we lose per year due to suicide or the mental disorders/disabilities that are brought on by the hearing issues.

I'm so grateful that Frequency is still moving ahead...

Agree. People need to treat these hearing issues seriously and that it's not just all about hearing loss that is the problem it's tinnitus and hyperacusis that people should be worried about. No wonder no one treats this condition seriously celebrities haven't even mention much about this.

 

[Lucifer]

FX-322 is developed for people with hearing loss.

What effect does FX-322 have on people with tinnitus? Does anyone know?

For Phase 2a clinical trials they added tinnitus as an indication. I would assume from the previous trials tinnitus was not made worse or it would be considered a major side effect.

 

[sssing]

Hi, based on everyone's comments on FX-322 drug delivery, I really hope they improve the delivery/diffusion of the drug... 6kHz meant the drug just moved about 8mm from the round window where it started... To a layman, that distance of 8mm seems like nothing!The whole cochlear duct is 32mm if straightened out... Could it be because there are two molecules to diffuse now instead of one? Really hope the reformulation can cause the drug to go further and help us!

 

[FGG]

FX-322 is developed for people with hearing loss.

What effect does FX-322 have on people with tinnitus? Does anyone know?

Most tinnitus is caused by hearing loss even if you don't notice it. So fixing the underlying problem should address the tinnitus.

If your tinnitus is caused outside the cochlea (e.g.. From TMJ), this drug won't help.

 

[Turgy]

Thank you, I hope the medication comes out as soon as possible, so that our suffering has an end.

 

[FGG]

Hi, based on everyone's comments on FX-322 drug delivery, I really hope they improve the delivery/diffusion of the drug... 6kHz meant the drug just moved about 8mm from the round window where it started... To a layman, that distance of 8mm seems like nothing!The whole cochlear duct is 32mm if straightened out... Could it be because there are two molecules to diffuse now instead of one? Really hope the reformulation can cause the drug to go further and help us!

View attachment 38740

We won't actually know how much it diffused until this trial is over. All we know so far is what the safety dose showed via an audiogram thus far. We will know a lot more after phase 2a.

 

[sssing]

We won't actually know how much it diffused until this trial is over. All we know so far is what the safety dose showed via an audiogram thus far. We will know a lot more after phase 2a.

Thanks @FGG... so it was the audiogram that showed that there were improvements up to 6kHz.

 

[FGG]

Thanks @FGG... so it was the audiogram that showed that there were improvements up to 6kHz.

They did not post the full audiograms but showed there was a 10dB improvement at 8000Hz in some participants. I think, though, they must have seen other improvements that fell under 10dB for them to use as graphic to show 6hz, but they didn't publish those because technically 5Hz is in margin of error.

The point is they didn't pull the number randomly but they aren't allowed (as a publically traded company) to make "predictive" graphics (which they did in the past with a 3500Hz graphic but revised it).

As phase 2a is blinded and still ongoing, the 6khz data could only have come from info in phase 1. Phase 2a results will tell us a lot more.

 

[Joly]

An improvement of 10dB, even if it's better than nothing, don't you think it's too little to regain hearing or reduce tinnitus? We may have a greater loss on high frequencies.

Do you think FX-322 could have a positive effect on TTTS?

 

[Fields]

I had my first (dis)appointment with an ENT today. She wasn't aware of any research that's being done into curing hearing problems and said I shouldn't expect any cures within my lifetime, nor did she seem interested in hearing about some of the research that's taking place.

From what I've gathered, this seems to be somewhat of a standard response in the Netherlands. It also makes me wonder to what extent a possible cure such as FX-322 will be prescribed here once it becomes available.

 

[Lucifer]

An improvement of 10dB, even if it's better than nothing, don't you think it's too little to regain hearing or reduce tinnitus? We may have a greater loss on high frequencies.

Do you think FX-322 could have a positive effect on TTTS?

I don't think it will be too little. You have to remember the current method they are using does not go below 6 kHz. Once they improve the delivery method it should help with all frequencies.

Maybe. The reason why I say maybe is because the Audion anecdote; someone was able to go rejoin his band again due to tinnitus and hyperacusis improving.

I think the reason why some of us get hyperacusis is due to the outer hair cells getting damaged. Once it restores the outer hair cells we should be able to get rid of the pain but also TTTS.

 

[Jaysterk]

I don't think it will be too little. You have to remember the current method they are using does not go below 6 kHz. Once they improve the delivery method it should help with all frequencies.

Maybe. The reason why I say maybe is because the Audion anecdote; someone was able to go rejoin his band again due to tinnitus and hyperacusis improving.

I think the reason why some of us get hyperacusis is due to the outer hair cells getting damaged. Once it restores the outer hair cells we should be able to get rid of the pain but also TTTS.

I agree. It only makes too much sense. Although current medicine seems to be lagging behind when it comes to the works of the inner ear, I feel like regenerative drugs such as FX-322 are jumping a few decades ahead presently.

 

[Lucifer]

I agree. It only makes too much sense. Although current medicine seems to be lagging behind when it comes to the works of the inner ear, I feel like regenerative drugs such as FX-322 are jumping a few decades ahead presently.

Agree. I think this is our real shot at getting rid of our hyperacusis and tinnitus. Especially the Audion anecdote has been giving me hope that FX-322 will succeed.