Frequency Therapeutics — Hearing Loss Regeneration

[Coleoptere]

Not sure about the approval for Regain. Regain communicated they will publish the results at the end of Phase II, now planned beginning 2020. No impression of effectiveness at the moment. I assume that Frequency Therapeutics will do the same. That is that they will communicate safety results beginning of next year and efficacy after phase 2.

Unknown is what they will do with the measurements of hearing levels they gathered during phase 1.

 

[Codaz]

What if hearing is lost due to an endolympathic hydrops (aka Meniere's), does the over presence of fluid in the inner ear also work with these new kinds of drugs?

 

[Street Novelist]

Why would they sit on the information? Sure, they are testing for safety, but at the same time they will know if it works. Either way, I hope they roll out the next phase quickly.

 

[d'Wooluf]

two completely unrelated entities

Slightly related maybe. Albert Edge is a co-founder of Audion. You also see him as co-author with some of the founders of Frequency Therapeutics on some pre-Frequency Therapeutics research. He's also a professor at Harvard Medical School, as are Langer and Karp (I think). So, there's a bit of commonality in their origins.

 

[katri]

What if hearing is lost due to an endolympathic hydrops (aka Meniere's), does the over presence of fluid in the inner ear also work with these new kinds of drugs?

It's probably too soon to tell.

 

[parsky]

They seem to be taking quite a while with their process, Frequency Therapeutics appears to be moving along much quicker.

The difference in pace is clearly pure market capitalism vs a government grant.

Not sure about the approval for Regain. Regain communicated they will publish the results at the end of Phase II, now planned beginning 2020. No impression of effectiveness at the moment. I assume that Frequency Therapeutics will do the same. That is that they will communicate safety results beginning of next year and efficacy after phase 2.

Unknown is what they will do with the measurements of hearing levels they gathered during phase 1.

Where did you see 2020?

 

[Coleoptere]

Check the Audion thread.

https://www.tinnitustalk.com/threads/audion-therapeutics-trial.21830/

 

[reeseth]

What if hearing is lost due to an endolympathic hydrops (aka Meniere's), does the over presence of fluid in the inner ear also work with these new kinds of drugs?

I sure hope it does. That is my condition. As of this spring I have problems with both ears. In theory it should work. So I'm sticking with that until proven otherwise.

 

[Ryzen]

Have they hinted at the potential side effects yet? What about complications with the delivery method?

 

[JohnAdams]

We need the US government to allow them to hurry this up.

 

[PDodge]

We need the US government to allow them to hurry this up.

Email FDA?

 

[JohnAdams]

Email FDA?

Won't do jack squat. It would take the ATA teaming up with WWP and going on Good Morning America and CNN and Fox News to push this to be expedited. Then you'd have all the Omni Consumer Products bipedal gun bots to contend with. It will probably not happen without some kind of miracle.

 

[Mr Mister]

I am not too familiar with FDA processes but I read that a drug development company might get fast tracked if it is for a life threatening condition or if the drug addresses an unmet medical need which currently does not have available treatment.

It sounds logical that solutions for life threatening conditions would be easier to get fast tracked as they save lives.

I don't think hearing loss/tinnitus are considered life threatening although you can argue about it.

But clearly FX-322 is for a condition that has no current therapy available and Frequency Therapeutics could seek for fast track approval based on that.

Does someone have information on how much on average the fast tracking actually speeds up time to market?

 

[JohnAdams]

I am not too familiar with FDA processes but I read that a drug development company might get fast tracked if it is for a life threatening condition or if the drug addresses an unmet medical need which currently does not have available treatment.

It sounds logical that solutions for life threatening conditions would be easier to get fast tracked as they save lives.

I don't think hearing loss/tinnitus are considered life threatening although you can argue about it.

But clearly FX-322 is for a condition that has no current therapy available and Frequency Therapeutics could seek for fast track approval based on that.

Does someone have information on how much on average the fast tracking actually speeds up time to market?

It speeds it up a lot. This trial is about to conclude within a month. Their CEO David Lucchino has stated in an interview that they will review their results early next year and if they look good they are going to request fast track/breakthrough status on FX-322. If this compound is everything we hope it is, we may very well get this much much sooner than we expect.

The ATA is dumb for not talking about this. They are tragic. At least they took the time to tell us they would be out for Thanksgiving. Like we would miss them. They actually owe us an apology, probably more than just one.

 

[streeter1985]

Have they hinted at the potential side effects yet? What about complications with the delivery method?

We will know the side effects when the drug is on the market... Let's hope it cures hearing loss and the side effect is to cure tinnitus

Delivery method seems to work like the intratympanic steroid injection. A needle goes through your eardrum and fills up the middle ear with the drug. After a while the drug will go into your cochlea (inner ear) and hopefully does what we pray for.

Concerning the delivery method (when I had my steroid injection) I had to sign a paper in the hospital, that I understand that when it goes completely wrong I might be deaf at the end of the surgery... For example the needle hits the bones inside the middle ear or goes too far and hits the inner ear etc. Of course worst case scenarios but still a risk.

Other important risks they mentioned... Permanent hole in your eardrum, scars or thickening on/of the eardrum that result in high frequency hearing loss, etc.

I think there are more but you can look them up if you search for the intratympanic steroid injection on the web.

 

[JohnAdams]

We will know the side effects when the drug is on the market... Let's hope it cures hearing loss and the side effect is to cure tinnitus

Delivery method seems to work like the intratympanic steroid injection. A needle goes through your eardrum and fills up the middle ear with the drug. After a while the drug will go into your cochlea (inner ear) and hopefully does what we pray for.

Concerning the delivery method (when I had my steroid injection) I had to sign a paper in the hospital, that I understand that when it goes completely wrong I might be deaf at the end of the surgery... For example the needle hits the bones inside the middle ear or goes too far and hits the inner ear etc. Of course worst case scenarios but still a risk.

Other important risks they mentioned... Permanent hole in your eardrum, scars or thickening on/of the eardrum that result in high frequency hearing loss, etc.

I think there are more but you can look them up if you search for the intratympanic steroid injection on the web.

I'd like to ask an ENT how rare complications with intratympanic injections are.

 

[lymebite]

I'd like to ask an ENT how rare complications with intratympanic injections are.

I had one done a couple years ago. My ENT said there was a 99 percent chance the hole would heal on its own within one week and a one percent chance it would not. Mine did heal. She did not mention other complications and I did not think to ask.

 

[rsmcfar]

I had several intratympanic injections about 5 years ago. ENT said he had only had one patient ever have an issue. I've not experienced any adverse effects, although I would not describe the experience as pleasant.

 

[Jim51042]

I had one done a couple years ago. My ENT said there was a 99 percent chance the hole would heal on its own within one week and a one percent chance it would not. Mine did heal. She did not mention other complications and I did not think to ask.

Did your hearing get affected by the hole/healing/scar tissue?

Any additional high frequency hearing loss due to the injection?

 

[lymebite]

Did your hearing get affected by the hole/healing/scar tissue?

Any additional high frequency hearing loss due to the injection?

No. I experienced no side effects of any kind.

 

[reeseth]

No. I experienced no side effects of any kind.

Neither did I. I have had betapred injected a couple of times. Not really any effect at all. Neither good nor bad.
The injection itself was OK. A bit weird when they removed the Emla cream from the eardrum.

 

[streeter1985]

I'd like to ask an ENT how rare complications with intratympanic injections are.

They are very very rare but I think it would be dubious if an ENT would say "do it, it's not risky at all". I am pretty sure you will have to sign a paper, where you see all the risks. Like every other surgery also this surgery contains some risks. I only would look out for some ENTs that are into ear surgery or have experience with this procedure. I mean there are some that do this every week and some only every 2-3 months.

If the drug really helps and the impact is as big as I hope, a lot of private ENTs will offer the procedure in their office too and many of them will be new to it. In Germany some ENTs offer the intratympanic injection in their office, while in other countries in middle EU, you only can get it in the hospital. I only was able to get my injection in an hospital.

I had three injections and if someone would ask me to do 10-20 more to cure or at least decrease my hearing loss and tinnitus I would do it again - no doubt - I would stay in front of the line to be the first to get it.

The only side effect concerning the injection was vertigo (sense of balance) for a short period of time right after the injection. The procedure is not comfortable at all but the worst part only lasts seconds.

 

[Flamingo1]

We need the US government to allow them to hurry this up.

Yay! You're back!

 

[papu]

I'd like to ask an ENT how rare complications with intratympanic injections are.

I think that they must be very rare. I had a lot of injections while in AM-101 trial with no real discomfort and each puncture was pretty much closed in the next session.

 

[JohnAdams]

I think that they must be very rare. I had a lot of injections while in AM-101 trial with no real discomfort and each puncture was pretty much closed in the next session.

AM-101 was intratympanic injections?

 

[PlsHelpMe]

If this drug works, will it also cure other complications related to hearing loss. Like hyperacusis and/or diplacusis?

 

[Alue]

I'd like to ask an ENT how rare complications with intratympanic injections are.

I think that they must be very rare. I had a lot of injections while in AM-101 trial with no real discomfort and each puncture was pretty much closed in the next session.

I had 18 injections total with the AM-101 trials (three round of three shots each in both ears). The only time I had a complication was the one time they used suctioning on my ear. Come to think of it, it was my right ear and I got a loud ringing for about half an hour when they suctioned it (and injected the real drug). The ringing went away, but my right ear has given me problems at a much later time. I actually think the long time window after acoustic trauma and the use of lidocaine/suctioning at many trial locations could have contributed to the inconsistent results during the trials.

If the doctor uses phenol to numb the eardrum instead of lidocaine there should be no reason to use suctioning unless they apply too much of it. IMHO, that's the biggest risk of the whole procedure if you have a competent ENT.

 

[Deathtotinni]

If this drug works, will it also cure other complications related to hearing loss. Like hyperacusis and/or diplacusis?

I would think so since hearing aids a lot of the time correct hyperacusis. Doc just told me the brain is overcompensating by making things appear loud because of the hearing loss. Of course I already knew this.

 

[Koz]

Current trials are to evaluate the safety of FX-322. I agree with you and hope there are no negative effects but that is what Frequency Therapeutics has to evaluate to get FDA clearance for Phase 2a. And to evaluate safety they need to set up the trials so that potential negative effects are measurable. If a patient has very little hearing left then potential negative effects can not be measured accurately.

I see little reason to speculate about whether this works for people with severe hearing loss as it has not been tested yet by Frequency Therapeutics. Those are the ones suffering most and we should be careful not to take away hope from them.

Interesting that they'd done two safety trials one for >70 dB (who have undergone cochlear implants) and another for <70 dB patients without any cochlear implants.

https://clinicaltrials.gov/ct2/show/study/NCT03300687

https://clinicaltrials.gov/ct2/show/record/NCT03616223

I am going to assume the trial for the patients with more than 70 dB hearing loss (severe/profound) who have undergone cochlear implant procedure is because negative outcomes can still be measured but do not matter much as the cochlear implant already completely surpasses the biological human inner ear anyway(?)

But then that makes no sense when opposed to the other trial which is for patients with under 70 dB hearing loss who as someone who got out of the trial said a negative outcome can be substantial hearing loss.

Maybe because there are possible measurable negative outcomes in both those samples compared to >70db without cochlear implants?

 

[d'Wooluf]

The first trial involved injection of the drug *before* the implant. I'd say this was so the cochlea could be examined in vitro to confirm that the drug reached the areas it was supposed to.