Frequency Therapeutics — Hearing Loss Regeneration

[Street Novelist]

I can't believe we have to wait until May just for the results. The trial started in October 2019. Even with the coronavirus, they must have the results by now? And if they do wait until May, when would the next trial start? Fall of 2021, a year from now? God forbid, 2022?

There are so many people on the verge of suicide, it just doesn't seem right. I know, at the end of the day, it's a business. But I don't understand why they are waiting so long to release the results!

 

[tommyd87]

I can't believe we have to wait until May just for the results. The trial started in October 2019. Even with the coronavirus, they must have the results by now? And if they do wait until May, when would the next trial start? Fall of 2021, a year from now? God forbid, 2022?

There are so many people on the verge of suicide, it just doesn't seem right. I know, at the end of the day, it's a business. But I don't understand why they are waiting so long to release the results!

Really right now the delay is all down to the fact that Frequency Therapeutics has:

> Only completed the total trial enrolment a month or so ago

> Actually need to wait 7 months to take the final results due to the dosing time and regrowth time required

> Are required to go through this trial process pretty much to demonstrate and also prove the necessary things to the FDA for approval and actually to be allowed to ultimately release FX-322

Even if it is the case that the trial participant at the very end of the phase 2a trial is getting the 4x placebo put in their ear, essentially it is a must that this is done due to the fact that Frequency Therapeutics must demonstrate to the FDA that there is no placebo benefit from FX-322.

My view is that this totally totally sucks too. However I also have had a very good feeling that there may have been positive results from the trial because otherwise I don't think that there would have been a discussion at the last session about things like hiring a pricing expert.

Essentially though there is no allowance or ability for Frequency Therapeutics to say stuff about the trial because this will get them in trouble with the FDA and actually also delay things further.

I expect that the trial after this current trial is going to be the final from what Frequency Therapeutics hinted to us and as a result reckon while it might take another 18 months before release, it is incredibly likely that this is going to be successful and also attain positive outcomes for all.

The FDA process sucks because we will need to wait, however the process is necessary to demonstrate that medicine is beneficial, safe and also absolutely and utterly fit for intended purpose.

 

[Lucifer]

I can't believe we have to wait until May just for the results. The trial started in October 2019. Even with the coronavirus, they must have the results by now? And if they do wait until May, when would the next trial start? Fall of 2021, a year from now? God forbid, 2022?

There are so many people on the verge of suicide, it just doesn't seem right. I know, at the end of the day, it's a business. But I don't understand why they are waiting so long to release the results!

Surely they have conclusive evidence that those who have taken 4 doses of FX-322 so far in the trial have shown greater improvements than a single dose of FX-322.

What doesn't make sense to me is that I thought they could have fewer participants for the phase 2a clinical trial due to the coronavirus but they wanted to get the original estimated number of participants for this trial. They could have just had fewer participants, reviewed the results now and move on to the next phase instead of getting more participants. Such a waste of time.

 

[FGG]

Surely they have conclusive evidence that those who have taken 4 doses of FX-322 so far in the trial have shown greater improvements than a single dose of FX-322.

It's a blinded study. You don't analyze the data until it's done.

As far as less participants, keep in mind that they plan to try to go pivotal next trial. The more participants they have, the more they can make that case to the FDA.

Frequency Therapeutics has every interest in getting FX-322 out as soon as possible.

 

[all to gain]

I can't believe we have to wait until May just for the results. The trial started in October 2019. Even with the coronavirus, they must have the results by now? And if they do wait until May, when would the next trial start? Fall of 2021, a year from now? God forbid, 2022?

There are so many people on the verge of suicide, it just doesn't seem right. I know, at the end of the day, it's a business. But I don't understand why they are waiting so long to release the results!

Life doesn't work like that though does it.

There are people dying left, right and centre from diseases, wars and famine on a daily basis, a few more from tinnitus and hearing issues is neither here nor there.

We will just have to wait our turn. Either that or protest directly to the president, but it will more than likely fall on deaf ears.

 

[patorjk]

Surely they have conclusive evidence that those who have taken 4 doses of FX-322 so far in the trial have shown greater improvements than a single dose of FX-322.

What doesn't make sense to me is that I thought they could have fewer participants for the phase 2a clinical trial due to the coronavirus but they wanted to get the original estimated number of participants for this trial. They could have just had fewer participants, reviewed the results now and move on to the next phase instead of getting more participants. Such a waste of time.

This is pure speculation, but if Phase IIa shows good results, there is a chance they could go to market during Phase 3. I was told this when I was apart of a Phase III cholesterol drug trial over a decade ago, and there's a WSJ article on the topic that states "Fast-tracked drugs often go to market after Phase 2. Drugs following the traditional path go through another phase." [1].

My assumption is that Frequency Therapeutics wants to dot all their I's and cross all their T's so that when they have the Phase IIa results, they're as compelling as possible. If they were to show the FDA that the drug helped 72 people (.75 * 96), that's more compelling than if it helped 36 (.75 * 48). And that's not even factoring in the statistically significant factor.

I'm not in the medial research profession though, so this is just me trying to read between the lines.

[1] https://www.wsj.com/articles/fast-t...ed-for-emergencies-is-now-routine-11562337924

 

[Lucifer]

This is pure speculation, but if Phase IIa shows good results, there is a chance they could go to market during Phase 3. I was told this when I was apart of a Phase III cholesterol drug trial over a decade ago, and there's a WSJ article on the topic that states "Fast-tracked drugs often go to market after Phase 2. Drugs following the traditional path go through another phase." [1].

My assumption is that Frequency Therapeutics wants to dot all their I's and cross all their T's so that when they have the Phase IIa results, they're as compelling as possible. If they were to show the FDA that the drug helped 72 people (.75 * 96), that's more compelling than if it helped 36 (.75 * 48). And that's not even factoring in the statistically significant factor.

I'm not in the medial research profession though, so this is just me trying to read between the lines.

[1] https://www.wsj.com/articles/fast-t...ed-for-emergencies-is-now-routine-11562337924

I do hope this is the case why they decided to stick to the estimated participants and delay the results. I would be so happy if they release FX-322 after this phase.

 

[Princebeyel]

I am definitely barely hanging on by a thread. I do not know how much longer I can go on like this. Hearing loss is the worst thing in the world! Wouldn't wish it on my worst enemy.

 

[tommyd87]

I am definitely barely hanging on by a thread. I do not know how much longer I can go on like this. Hearing loss is the worst thing in the world! Wouldn't wish it on my worst enemy.

Yeah, to just have normal speech stuff back would be awesome.

 

[tommyd87]

This is pure speculation, but if Phase IIa shows good results, there is a chance they could go to market during Phase 3. I was told this when I was apart of a Phase III cholesterol drug trial over a decade ago, and there's a WSJ article on the topic that states "Fast-tracked drugs often go to market after Phase 2. Drugs following the traditional path go through another phase." [1].

My assumption is that Frequency Therapeutics wants to dot all their I's and cross all their T's so that when they have the Phase IIa results, they're as compelling as possible. If they were to show the FDA that the drug helped 72 people (.75 * 96), that's more compelling than if it helped 36 (.75 * 48). And that's not even factoring in the statistically significant factor.

I'm not in the medial research profession though, so this is just me trying to read between the lines.

[1] https://www.wsj.com/articles/fast-t...ed-for-emergencies-is-now-routine-11562337924

If it's true that there could be a release post phase 2 then this would make further sense about why we are seeing them try and complete things meticulously especially when this is both an unmet need and a new drug. I definitely could then see them go and run the phase 3 globally to complete the process and collect their pay.

I'm pretty hopeful that Otonomy might take a similar position with OTO-413 then too if they can get their dosing right and get successful outcomes through the current trial.

 

[RB2014]

I am definitely barely hanging on by a thread. I do not know how much longer I can go on like this. Hearing loss is the worst thing in the world! Wouldn't wish it on my worst enemy.

Hang in there. I guarantee my hearing chart makes yours look good. I've been waiting for a long time. Another year and a half is nothing.

 

[Lucifer]

I am definitely barely hanging on by a thread. I do not know how much longer I can go on like this. Hearing loss is the worst thing in the world! Wouldn't wish it on my worst enemy.

I know how you feel. I'm also hanging on by a thread but there have been so many clinical trials such as FX-322, OTO-413 etc that one of these drugs or multiple may work for us and I wouldn't want to leave my family behind if there was a chance I could be cured in 1-2 years time.

 

[Görkem]

Hello, can you guys help me. I have had hearing loss in one ear for 10 years (I'm 21).

I have had tinnitus in the other ear for 1 year.

Will FX-322 help me? I don't want to wait in hope.

 

[Princebeyel]

I guarantee my hearing chart makes yours look good.

Want to bet?

 

[waly]

Hello, can you guys help me. I have had hearing loss in one ear for 10 years (I'm 21).

I have had tinnitus in the other ear for 1 year.

Will FX-322 help me? I don't want to wait in hope.

The chances are high, but nobody knows what will happen in the future.

 

[Görkem]

The chances are high, but nobody knows what will happen in the future.

Thank you for your response. I hope we all will be cured.

 

[RB2014]

Want to bet?

Let's do it!

Hopefully this makes people understand why some of us don't get excited over 10 dB at 8 kHz...

I'm in for 8-10 shots in each ear! Assuming I can gain 10 dB each time in all frequencies, not just one.

 

[TrevorSanders]

Let's do it!

Hopefully this makes people understand why some of us don't get excited over 10 dB at 8 kHz...

I'm in for 8-10 shots in each ear! Assuming I can gain 10 dB each time in all frequencies, not just one.

View attachment 41015

Mic drop.

 

[all to gain]

Let's do it!

Hopefully this makes people understand why some of us don't get excited over 10 dB at 8 kHz...

I'm in for 8-10 shots in each ear! Assuming I can gain 10 dB each time in all frequencies, not just one.

View attachment 41015

Are you pretty much totally deaf then? Did you have gradual loss or was it all at once?

Would FX-322 do much of anything for you? Sorry to be a downer.

 

[ThomasRobert]

Want to bet?

If I may ask, did you get hearing loss and tinnitus because of the ventilator (and most probably from the meds that were given to you)? You had COVID-19?

 

[FGG]

View attachment 41015

It looks like you have an air/bone gap and some conductive losses as well as SSHL.

Do they know why?

 

[RB2014]

Are you pretty much totally deaf then? Did you have gradual loss or was it all at once?

Would FX-322 do much of anything for you? Sorry to be a downer.

It has been a gradual loss from age 15 all the way to age 47. Believe it or not I am not totally deaf. I wear super powerful hearing aids and with lip reading I actually get by ok. Not great, but ok. 0 Hz to 2 kHz is the most usable frequency range... door slams, people with low voices... I won't lie, it's bad, without my hearing aids I can only hear if you talk very loudly at close range. I haven't heard a bird in a long time. Even with my hearing aids I can't hear the microwave beep.

If I may ask, did you get hearing loss and tinnitus because of the ventilator (and most probably from the meds that were given to you)? You had COVID-19?

Nope, it's genetic... Same thing happened to my dad by this age. Listening to loud music when I was a teenager didn't help. Having subwoofers in my car didn't help. I only hit 3 concerts but now that I look back I was doing damage at each one.

It looks like you have an air/bone gap and some conductive losses as well as SSHL.

Do they know why?

It's genetic. My hearing has slowly deteriorated at a faster rate than normal. I haven't done any tests to see why. All they do is give me hearing aids and they work really well. Without them I would be totally lost. There is nothing that can be done. I think my only issue is loss of hair cells. Again it's been a very very slow... or fast... loss.. however you want to look at it.

Believe it or not but 10 dB in all frequencies would be life changing for me. 10 dB at 8 kHz is not. 10 dB at 1 kHz would help out a lot more... I was really hoping for better results after seeing the preliminary data and I'll stay positive until we hear back on the next phase. I can tell you from the many many hearing tests I have done that 10 dB at 8 kHz is very easy to miss, especially with tinnitus... and believe it or not I get better at word scores as more words are read to me.

We really need the data from the next trial to make any conclusions on how effective FX-322 will be.

 

[Princebeyel]

If I may ask, did you get hearing loss and tinnitus because of the ventilator (and most probably from the meds that were given to you)? You had COVID-19?

It was the meds. No, I did not have COVID-19.

Do any of you guys have an idea if FX-322 would help me? I tried to get into the clinical trial but wasn't accepted because my hearing loss was too great?

 

[FGG]

It has been a gradual loss from age 15 all the way to age 47. Believe it or not I am not totally deaf. I wear super powerful hearing aids and with lip reading I actually get by ok. Not great, but ok. 0 Hz to 2 kHz is the most usable frequency range... door slams, people with low voices... I won't lie, it's bad, without my hearing aids I can only hear if you talk very loudly at close range. I haven't heard a bird in a long time. Even with my hearing aids I can't hear the microwave beep.

Nope, it's genetic... Same thing happened to my dad by this age. Listening to loud music when I was a teenager didn't help. Having subwoofers in my car didn't help. I only hit 3 concerts but now that I look back I was doing damage at each one.

It's genetic. My hearing has slowly deteriorated at a faster rate than normal. I haven't done any tests to see why. All they do is give me hearing aids and they work really well. Without them I would be totally lost. There is nothing that can be done. I think my only issue is loss of hair cells. Again it's been a very very slow... or fast... loss.. however you want to look at it.

Believe it or not but 10 dB in all frequencies would be life changing for me. 10 dB at 8 kHz is not. 10 dB at 1 kHz would help out a lot more... I was really hoping for better results after seeing the preliminary data and I'll stay positive until we hear back on the next phase. I can tell you from the many many hearing tests I have done that 10 dB at 8 kHz is very easy to miss, especially with tinnitus... and believe it or not I get better at word scores as more words are read to me.

We really need the data from the next trial to make any conclusions on how effective FX-322 will be.

If it's just hair cells, do they know why you have an air/bone gap at some frequencies?

I would agree that most of your problem is SSNL but this looks mixed conductive/SSNL to me. I wonder if a bone conduction hearing aid would at least take you out of the profound range for some of those frequencies.

 

[FGG]

It was the meds. No, I did not have COVID-19.

Do any of you guys have an idea if FX-322 would help me? I tried to get into the clinical trial but wasn't accepted because my hearing loss was too great?

Part of your issue with getting in the trial might be because you also have conductive hearing losses in addition to SNHL.

This was an exclusion:

1. Any conductive hearing loss of greater than 15 dB at a single frequency or greater than 10 dB at two or more contiguous octave frequencies in the study ear at the Screening visit or on the prior audiogram (if the Investigator feels there is not a true conductive hearing loss, the Medical Monitor should be consulted).

I think FX-322 could help some of your SNHL.

 

[tommyd87]

It was the meds. No, I did not have COVID-19.

Do any of you guys have an idea if FX-322 would help me? I tried to get into the clinical trial but wasn't accepted because my hearing loss was too great?

The trial required a very specific type of hearing loss, literally because they felt that this type would be the most suitable for the trial. Therefore the trial participants' hearing loss does not represent the range of hearing loss FX-322 can treat.

Frequency Therapeutics has already indicated that they would be looking at further kinds of hearing loss in future trials, although the theory that many have is that they are at present focused on getting FX-322 through the trials and nothing else. This is probably why they picked the type of hearing loss that they did because it is inevitably going to get the best improvement from the trials and as a result will get approval from the FDA too.

 

[RB2014]

It was the meds. No, I did not have COVID-19.

Do any of you guys have an idea if FX-322 would help me? I tried to get into the clinical trial but wasn't accepted because my hearing loss was too great?

Right now no one can accurately answer this question.

We think a larger dose might help, we think multiple doses might help, we think if it can get further into the ear it will help with lower frequencies. Right now all we can do is speculate. I've read everything from deaf mice being completely cured to people that have severe hearing loss no longer having supporting cells and this won't work for them. We really need to hold out for the data in the next trial to see how some of these factors pan out.

We are both in a very similar boat. There were a lot of preliminary experiments that have yielded positive results but they didn't translate as well as we had hoped in the last clinical trial. Now they just have to figure out why and what happened and how they can get better results.

Did you have perfect hearing before the medications? And did the medications cause that much hearing loss? For what it's worth, if it was the medications, your hearing loss will not get worse in the immediate future which is good news. Get hearing aids if you don't have them and if you have them, use them every day.

There are a lot of good conversations going back and forth between all of the members here and a lot of good information in this thread.

 

[Pete88]

It has been a gradual loss from age 15 all the way to age 47. Believe it or not I am not totally deaf. I wear super powerful hearing aids and with lip reading I actually get by ok. Not great, but ok. 0 Hz to 2 kHz is the most usable frequency range... door slams, people with low voices... I won't lie, it's bad, without my hearing aids I can only hear if you talk very loudly at close range. I haven't heard a bird in a long time. Even with my hearing aids I can't hear the microwave beep.

Nope, it's genetic... Same thing happened to my dad by this age. Listening to loud music when I was a teenager didn't help. Having subwoofers in my car didn't help. I only hit 3 concerts but now that I look back I was doing damage at each one.

It's genetic. My hearing has slowly deteriorated at a faster rate than normal. I haven't done any tests to see why. All they do is give me hearing aids and they work really well. Without them I would be totally lost. There is nothing that can be done. I think my only issue is loss of hair cells. Again it's been a very very slow... or fast... loss.. however you want to look at it.

Believe it or not but 10 dB in all frequencies would be life changing for me. 10 dB at 8 kHz is not. 10 dB at 1 kHz would help out a lot more... I was really hoping for better results after seeing the preliminary data and I'll stay positive until we hear back on the next phase. I can tell you from the many many hearing tests I have done that 10 dB at 8 kHz is very easy to miss, especially with tinnitus... and believe it or not I get better at word scores as more words are read to me.

We really need the data from the next trial to make any conclusions on how effective FX-322 will be.

Very sorry to hear your situation but on the bright side, even if FX-322 doesn't free you of the hearing aid, it will expand what you can easily understand with the hearing aid and hopefully improve your life a bit!

 

[Pete88]

It looks like you have an air/bone gap and some conductive losses as well as SSHL.

Do they know why?

Just out of curiosity, what does air/bone gap mean or imply and how can you tell?

 

[Pete88]

It was the meds. No, I did not have COVID-19.

Do any of you guys have an idea if FX-322 would help me? I tried to get into the clinical trial but wasn't accepted because my hearing loss was too great?

Since your issue was ototoxic medicine, I would assume it killed the hair cells, in which case, yes, I think FX-322 will help you. It's crazy and disturbing to see how much damage medicine did to you. Was your hearing normal before the medicine?