Frequency Therapeutics — Hearing Loss Regeneration

[Jurger]

They could have one phase for safety and initial efficacy.

You mean a combined Phase 1 and Phase 1/2?

 

[Flamingo1]

This will happen to FREQ one day.

https://www.cnbc.com/2019/10/22/bio...rs-drug-sending-shares-soaring-34percent.html

 

[JohnAdams]

You mean a combined Phase 1 and Phase 1/2?

Yeah at the least. Why can't they submit efficacy and safety data at the same time?

 

[Street Novelist]

Has anyone here called the trial center in Fresno? It's only a half a day's driving from where I live.

 

[JohnAdams]

Has anyone here called the trial center in Fresno? It's only a half a day's driving from where I live.

Fresno, Italy?

 

[Staceyyy]

Has anyone here called the trial center in Fresno? It's only a half a day's driving from where I live.

I called the center in Kentucky. I left a message. I haven't heard anything back yet.

 

[Jurger]

Yeah at the least. Why can't they submit efficacy and safety data at the same time?

Because Phase 1 was primarily about bioavailability in the cochlea. That's why they picked CI patients. They couldn't test for efficacy because those patients were about to get a CI. The alternative would have been to cut 'non-CI patients' open to see how much drug is in their cochlea after administering it.

I honestly think they're going as fast as they can. Fast track status will probably help them get from Phase 2a to 2b quicker. I do agree help from Astellas could be useful in a Phase 3, where they can help with large scale patient recruiting and finding hospitals that will participate.

 

[JohnAdams]

Considering how debilitating this condition is, I think that anyone that thinks we should have to wait for any significant amount of time to get this treatment, if it indeed shows efficacy for tinnitus, is absolutely insane.

 

[JohnAdams]

Because Phase 1 was primarily about bioavailability in the cochlea. That's why they picked CI patients. They couldn't test for efficacy because those patients were about to get a CI. The alternative would have been to cut 'non-CI patients' open to see how much drug is in their cochlea after administering it.

I honestly think they're going as fast as they can. Fast track status will probably help them get from Phase 2a to 2b quicker. I do agree help from Astellas could be useful in a Phase 3, where they can help with large scale patient recruiting and finding hospitals that will participate.

Not phase 1b. Phase 3 should be open.

 

[Staceyyy]

I was able to speak to someone at the Kentucky center today. I faxed them my audiograms. Just waiting for them to get back to me... Wish me luck.

 

[ChrisBoyMonkey]

I was able to speak to someone at the Kentucky center today. I faxed them my audiograms. Just waiting for them to get back to me... Wish me luck.

How is your hearing loss? Up to 8 kHz my hearing loss is no more than 10 dB on any frequency so I don't think I would qualify... If only they could accept hearing loss over 8 kHz...

 

[Street Novelist]

I was able to speak to someone at the Kentucky center today. I faxed them my audiograms. Just waiting for them to get back to me... Wish me luck.

Good luck Stacey!

 

[SouthKorean]

Found a video that explains the effects of FX-322.

 

[hopeful4future]

I reached out to the number on the clinical trials website and it went straight to voicemail, I left a message for more information on the location I was requesting. Within a few hours a lady called back and gave me all the information regarding the location I am interested in, I was not able to answer so she left a voicemail. I reached out to that location and spoke to them regarding the trial, I did not ask many questions, just what they needed to see if I qualified.

They wanted a hearing test that has been taken within the past 6 months (which I just happened to have on my phone). She said she would need to give that to the audiologists that was working on the trial and get back to me. She also stated that if my test provided fell within the inclusion criteria I would have to visit them. The visit would include a hearing test from them and a 3 hour assessment to see if I would qualify.

It's going on 2 days since I've sent over my hearing test.

I also read on Frequency Therapeutics website there are only 95 participants in phase 2 trial. I hope that's not 95 people across all locations but rather 95 people per location.

Sorry if any of this is duplicate information, just wanted to relay what I know.

 

[Daniel Lion]

I reached out to the number on the clinical trials website and it went straight to voicemail, I left a message for more information on the location I was requesting. Within a few hours a lady called back and gave me all the information regarding the location I am interested in, I was not able to answer so she left a voicemail. I reached out to that location and spoke to them regarding the trial, I did not ask many questions, just what they needed to see if I qualified.

They wanted a hearing test that has been taken within the past 6 months (which I just happened to have on my phone). She said she would need to give that to the audiologists that was working on the trial and get back to me. She also stated that if my test provided fell within the inclusion criteria I would have to visit them. The visit would include a hearing test from them and a 3 hour assessment to see if I would qualify.

It's going on 2 days since I've sent over my hearing test.

I also read on Frequency Therapeutics website there are only 95 participants in phase 2 trial. I hope that's not 95 people across all locations but rather 95 people per location.

Sorry if any of this is duplicate information, just wanted to relay what I know.

Thank you hopeful4future.

When you follow up, could you please ask about the 95 participant question, i.e. in total or per location?

Thanks.

 

[ajc]

It's very likely 95 patients in total, not per trial center.

Phase 2 studies are often that size.

If it was 95 patients per trial center, we'd be looking at phase 3 study...

 

[Staceyyy]

How is your hearing loss? Up to 8 kHz my hearing loss is no more than 10 dB on any frequency so I don't think I would qualify... If only they could accept hearing loss over 8 kHz...

So I have mild to moderate low frequency hearing loss. I'm worried FX-322 may only benefit people with high frequency loss.

 

[Jurger]

So I have mild to moderate low frequency hearing loss. I'm worried FX-322 may only benefit people with high frequency loss.

That's why you would be an excellent candidate. I don't think by the way the drug itself is ineffective for low frequency hearing loss, but that the drug concentration isn't high enough in the apex of the cochlea because of the limitations of intratympanic drug delivery, if it even reaches the apex at all. Improving delivery methods will probably sort that out eventually.

 

[Caveman]

That's why you would be an excellent candidate. I don't think by the way the drug itself is ineffective for low frequency hearing loss, but that the drug concentration isn't high enough in the apex of the cochlea because of the limitations of intratympanic drug delivery, if it even reaches the apex at all. Improving delivery methods will probably sort that out eventually.

How could they improve?

 

[Enclave]

I reached out to the number on the clinical trials website and it went straight to voicemail, I left a message for more information on the location I was requesting. Within a few hours a lady called back and gave me all the information regarding the location I am interested in, I was not able to answer so she left a voicemail. I reached out to that location and spoke to them regarding the trial, I did not ask many questions, just what they needed to see if I qualified.

They wanted a hearing test that has been taken within the past 6 months (which I just happened to have on my phone). She said she would need to give that to the audiologists that was working on the trial and get back to me. She also stated that if my test provided fell within the inclusion criteria I would have to visit them. The visit would include a hearing test from them and a 3 hour assessment to see if I would qualify.

It's going on 2 days since I've sent over my hearing test.

I also read on Frequency Therapeutics website there are only 95 participants in phase 2 trial. I hope that's not 95 people across all locations but rather 95 people per location.

Sorry if any of this is duplicate information, just wanted to relay what I know.

If you hear back from them, can you ask them about the volume of drug they'll be injecting and ask them if they've increased the concentration of the drug from the amount that was used in Phase 1b?

I called the Fresno facility yesterday and haven't heard back, but I'm planning on asking as much as possible to see what they reveal. I'll report back if I get anything.

 

[Jurger]

How could they improve?

There are a couple of things in the pipeline. First up are intracochlear injections. Instead of letting a drug permeate through the round window membrane, you inject the drug directly through the round window membrane. The risk of damage to your hearing is greater and there's a risk of perilymph leakage through the hole that's made, but they're trying to work around that using microneedles (Columbia University is on this). There are some doubts drugs delivered this way will sufficiently reach the apex, but it does have advantages over intratympanic injections.

The second option is nanoparticles, where you load drugs in nanoparticles, inject the particles through the eardrum and then push the particles in the inner ear. It's also an intracochlear method.

Then there's a technique where they use an outside pump to pump drugs in your cochlea. That's also basically a variation of intracochlear delivery.

It is important to note that I think developing new delivery methods and developing drugs to treat hearing loss and other otologic diseases can run independently. For example, if and once FX-322 is approved, it can be used in combination with new delivery methods that are released later on, provided the delivery method has approval from the FDA as well. There's a separate approval process for 'medical devices', which I think most delivery methods qualify as.

 

[Caveman]

There are a couple of things in the pipeline. First up are intracochlear injections. Instead of letting a drug permeate through the round window membrane, you inject the drug directly through the round window membrane. The risk of damage to your hearing is greater and there's a risk of perilymph leakage through the hole that's made, but they're trying to work around that using microneedles (Columbia University is on this). There are some doubts drugs delivered this way will sufficiently reach the apex, but it does have advantages over intratympanic injections.

The second option is nanoparticles, where you load drugs in nanoparticles, inject the particles through the eardrum and then push the particles in the inner ear. It's also an intracochlear method.

Then there's a technique where they use an outside pump to pump drugs in your cochlea. That's also basically a variation of intracochlear delivery.

It is important to note that I think developing new delivery methods and developing drugs to treat hearing loss and other otologic diseases can run independently. For example, if and once FX-322 is approved, it can be used in combination with new delivery methods that are released later on, provided the delivery method has approval from the FDA as well. There's a separate approval process for 'medical devices', which I think most delivery methods qualify as.

The thing is I'd like to get the injections in a 3/4 years' time at the very least, whereas you're talking about innovations that might occur in the looong run...

 

[hopeful4future]

So I have mild to moderate low frequency hearing loss. I'm worried FX-322 may only benefit people with high frequency loss.

I am the same way. I have a low frequency hearing loss. I have a 50 dB dip at 750 Hz & 1000 Hz. Not sure if I got approved for the trial if it's even be worth it. Also worried about making things worse.

 

[JohnAdams]

Also worried about making things worse.

It will not make anything worse I promise you.

 

[Jurger]

The thing is I'd like to get the injections in a 3/4 years' time at the very least, whereas you're talking about innovations that might occur in the looong run...

Not necessarily. Otomagnetics wants to do a clinical trial soon. They are at the forefront of nanoparticles. Meanwhile, if this comes out you can still get it administered intratympanically and then do it again when better delivery methods are out.

 

[hopeful4future]

It will not make anything worse I promise you.

Mr Adams what is your opinion on FX-322? I'm sure it's probably been stated previously in this thread, but call me lazy! Do you think it works or not? And how are you so sure it won't make things worse?

 

[JohnAdams]

Mr Adams what is your opinion on FX-322? I'm sure it's probably been stated previously in this thread, but call me lazy! Do you think it works or not? And how are you so sure it won't make things worse?

Yes, I think this will reduce or eliminate tinnitus caused by noise damage and do so very well for high frequency tinnitus where the hearing loss is less than 20dB. This substance is not ototoxic, and no worsening of hearing has been reported in their safety trials, I think.

 

[Auron]

There are a couple of things in the pipeline. First up are intracochlear injections. Instead of letting a drug permeate through the round window membrane, you inject the drug directly through the round window membrane. The risk of damage to your hearing is greater and there's a risk of perilymph leakage through the hole that's made, but they're trying to work around that using microneedles (Columbia University is on this). There are some doubts drugs delivered this way will sufficiently reach the apex, but it does have advantages over intratympanic injections.

The second option is nanoparticles, where you load drugs in nanoparticles, inject the particles through the eardrum and then push the particles in the inner ear. It's also an intracochlear method.

Then there's a technique where they use an outside pump to pump drugs in your cochlea. That's also basically a variation of intracochlear delivery.

It is important to note that I think developing new delivery methods and developing drugs to treat hearing loss and other otologic diseases can run independently. For example, if and once FX-322 is approved, it can be used in combination with new delivery methods that are released later on, provided the delivery method has approval from the FDA as well. There's a separate approval process for 'medical devices', which I think most delivery methods qualify as.

Seems like that's a lot of work needed to be done.

I wonder how Hough Ear Institute's pill works, and why others haven't pursued a pill route since it seems that they are the only ones in clinical trial stage doing it.

 

[Jurger]

Yes, I think this will reduce or eliminate tinnitus caused by noise damage and do so very well for high frequency tinnitus where the hearing loss is less than 20dB. This substance is not ototoxic, and no worsening of hearing has been reported in their safety trials, I think.

Just to add some caution. All these these new therapeutics - whether it's FX-322, REGAIN, CGF166, Hough's siRNA etc. - operate under the assumption that human supporting cells can induce hair cell growth. Until one of these companies/institutes releases Phase 2 results, we don't know if that's the case. Yes, there's promising in vitro and in vivo work, but as someone very wise once said: if mouse results were fully indicative of human results, humanity would be disease free by now. Plenty of drugs that showed promising results in in vivo work, eventually failed in human trials.

The other thing is that even if these theories hold up, there will still be a patient population that won't be helped, either because their hearing loss is too great (too few supporting cells), or the cause of their hearing loss is not hair cell related (neuropathy, Vestibular Schwannoma, brain damage etc.).

Another obstacle in treating hearing loss is the lack of diagnostic tools. There is no imaging technology or way to test perilymph of the inner ear to see what's going on in a patients inner ear. All we have are hearing tests, which are far from perfect. That makes screening patients for therapies a lot harder.

And then there's of course the problem of inner ear drug delivery, which I won't nag about again.

 

[Staceyyy]

I am the same way. I have a low frequency hearing loss. I have a 50 dB dip at 750 Hz & 1000 Hz. Not sure if I got approved for the trial if it's even be worth it. Also worried about making things worse.

I dip down to 30 dB at 250 Hz, 45 dB at 500 Hz, and 35 dB at 1000 Hz. The rest of my audiogram is normalish.