Audion Therapeutics Trial

[Coleoptere]

@patorjk, not too much I assume...:

Dear John,

Indeed, at this stage we cannot disclose the results of our REGAIN study yet.

We can share that we have successfully completed the Phase I safety study and will start the Phase II efficacy study within the next few weeks. The results of the phase I and II REGAIN studies will be published after the completion and data analysis of both studies; we are aiming for early 2020. We would encourage you to sign up to our newsletter and the evidENT page on twitter @evidENT_UCL to receive updates on the REGAIN trial.

 

[Lucifer]

@patorjk, not too much I assume...:

How long ago was this email? I thought they finished Phase 2 end of last year and are now going through the results and reviewing it?

They expect the results to be released end of April.

 

[Coleoptere]

@Lucifer : good point! It dropped off while I was editing. This post was done a year ago. So it was known for some time. So a year ago they took some space when the results would be there so I assume nothing special is going on at Audion when they mention April.

 

[Coleoptere]

... and here you can find the source:

https://www.actiononhearingloss.org...earing-loss-to-take-part-in-a-clinical-trial/

 

[Daniel Lion]

Bumping this thread... it is April indeed.
Anyone see anything worth reporting?
I have emailed the REGAIN project and am waiting for a reply.

 

[Lucifer]

Bumping this thread... it is April indeed.
Anyone see anything worth reporting?
I have emailed the REGAIN project and am waiting for a reply.

They stated on the clinical trials page that results will be posted on April 30th but could be delayed due to coronavirus.

When did you email them? It took me around 2-3 weeks to get a reply from them. I asked them if results will be still posted on April 30th but they couldn't say. This was earlier on in the year.

 

[Daniel Lion]

They stated on the clinical trials page that results will be posted on April 30th but could be delayed due to coronavirus.

When did you email them? It took me around 2-3 weeks to get a reply from them. I asked them if results will be still posted on April 30th but they couldn't say. This was earlier on in the year.

About two weeks ago, and I sent a follow up mail this morning.

Perhaps you could send another mail as well. Can't hurt.

Well it ain't April 30th, so wait and see.

Super curious and hopeful that the participants had great results.

 

[Lucifer]

About two weeks ago, and I sent a follow up mail this morning.

Perhaps you could send another mail as well. Can't hurt.

Well it ain't April 30th, so wait and see.

Super curious and hopeful that the participants had great results.

They take a very long time to reply. Maybe longer now due to coronavirus. I'll send them another email as well.

Keep me up to date

 

[serendipity1996]

It's just hit me that this is only a couple of weeks away (if not delayed by COVID-19 ofc). So hyped.

 

[xyz]

How long ago was this email? I thought they finished Phase 2 end of last year and are now going through the results and reviewing it?

They expect the results to be released end of April.

Seems like there is happening a lot on the hearing regeneration front currently. Does somebody have the link to this phase 2 trial on ClinicalTrials.gov? I couldn't find it there when I searched for Audion.

 

[Jim51042]

They take a very long time to reply. Maybe longer now due to coronavirus. I'll send them another email as well.

There is absolutely no excuse for not drafting a paper on the results due to the coronavirus. With the stay at home order they should be posting the paper well ahead of schedule. Also these scientists have email access from their homes and should be responding to emails within minutes.

 

[Lucifer]

Seems like there is happening a lot on the hearing regeneration front currently. Does somebody have the link to this phase 2 trial on ClinicalTrials.gov? I couldn't find it there when I searched for Audion.

http://www.isrctn.com/ISRCTN59733689

 

[Mentos]

There is absolutely no excuse for not drafting a paper on the results due to the coronavirus. With the stay at home order they should be posting the paper well ahead of schedule. Also these scientists have email access from their homes and should be responding to emails within minutes.

This delay in answering to potential patients' mails is not a good sign, as if they were not interested in getting public attention.

 

[xyz]

Really interesting to see the results end of April. They have tinnitus listed also as an outcome measure which will be probably most interesting for us here. Does somebody know if the labs which are currently working on hearing regeneration all use the same approach or are they independently trying to get our hair cells fixed?

 

[Lucifer]

Really interesting to see the results end of April. They have tinnitus listed also as an outcome measure which will be probably most interesting for us here. Does somebody know if the labs which are currently working on hearing regeneration all use the same approach or are they independently trying to get our hair cells fixed?

Compared to Frequency Therapeutics it depletes supporting hair cells which may be needed for FX-322 to work.

In the previous pages of this thread there was an anecdote that someone who was able to go back to performing in the band due to tinnitus and hyperacusis improving.

This gives me hope that both Audion Therapeutics and Frequency Therapeutics should help us with our tinnitus and hyperacusis.

 

[serendipity1996]

Really interesting to see the results end of April. They have tinnitus listed also as an outcome measure which will be probably most interesting for us here. Does somebody know if the labs which are currently working on hearing regeneration all use the same approach or are they independently trying to get our hair cells fixed?

Frequency is using a different method to Audion - basically the gist of it is (from what I can recall) that FX-322 duplicates support cells whereas Audion depletes them. Frequency are pioneering a technique called progenitor cell activation and Regain are using a notch inhibition therapy. I don't have a scientific background by any means but I think the general perception is that FX-322's technique may be slightly 'superior'...

 

[FGG]

Frequency is using a different method to Audion - basically the gist of it is (from what I can recall) that FX-322 duplicates support cells whereas Audion depletes them. Frequency are pioneering a technique called progenitor cell activation and Regain are using a notch inhibition therapy. I don't have a scientific background by any means but I think the general perception is that FX-322's technique may be slightly 'superior'...

Possibly more than slightly depending on who you ask .

 

[Tweedleman]

Possibly more than slightly depending on who you ask .

I can't seem to find it now but I read a paper a while ago that said hair cells and support cells rely on each other. Not sure how well that bodes for Audion's regenetated hair cells.

 

[d'Wooluf]

There is absolutely no excuse for not drafting a paper on the results due to the coronavirus.

I don't think that COVID-19 has changed their schedule in any way so far. I never got why it takes them six months to report their results (same as Frequency Therapeutics come to that). It's not like there's millions of data points they have to analyse.

as if they were not interested in getting public attention.

They haven't sought publicity much in the couple of years I've been following them.

Also these scientists have email access from their homes and should be responding to emails within minutes.

Why's that really? It would be nice if they could, workload and deadlines permitting, but I don't think we have the right to demand it. Especially when they probably aren't allowed to answer most of our questions anyway.

 

[Jim51042]

Why's that really? It would be nice if they could, workload and deadlines permitting, but I don't think we have the right to demand it. Especially when they probably aren't allowed to answer most of our questions anyway.

Yea agree. The minutes response more between their own employees. The main point is that even though they aren't in the lab all employees need to be working tirelessly (labor laws be damned) to communicate their findings within the next couple weeks.

 

[mrbrightside614]

Frequency is using a different method to Audion - basically the gist of it is (from what I can recall) that FX-322 duplicates support cells whereas Audion depletes them. Frequency are pioneering a technique called progenitor cell activation and Regain are using a notch inhibition therapy. I don't have a scientific background by any means but I think the general perception is that FX-322's technique may be slightly 'superior'...

We're unclear on support cell multiplication at this time. There are elements of the original patent and some verbiage in the corporate presentation that may allude to this outcome but we're not sure. This is one of the questions I really want answered, because if "rinse and repeat" therapy is viable, it should render continuously more favorable returns. Especially for certain tinnitus etiologies.

 

[serendipity1996]

I don't think that COVID-19 has changed their schedule in any way so far. I never got why it takes them six months to report their results (same as Frequency Therapeutics come to that). It's not like there's millions of data points they have to analyse.

They haven't sought publicity much in the couple of years I've been following them.

Why's that really? It would be nice if they could, workload and deadlines permitting, but I don't think we have the right to demand it. Especially when they probably aren't allowed to answer most of our questions anyway.

Yeah, I agree - I don't think it's entirely reasonable for us to expect responses within 'minutes' round the clock - after all these are people with their own lives to take care of too, families etc.

 

[Lucifer]

Can't wait for the results to come out next week. Hopefully there's not a delay due to COVID-19.

 

[Mistertdog15]

I don't know why people are not as hyped for this to be honest because if we see positive results for tinnitus in this then we will definitely see positive/better results from FX-322, too.

Are they going to tell us if tinnitus improved in the patients or no?

 

[FGG]

I don't know why people are not as hyped for this to be honest because if we see positive results for tinnitus in this then we will definitely see positive/better results from FX-322, too.

Are they going to tell us if tinnitus improved in the patients or no?

Personally, I am not as hyped because I have some reservations about their method. Their drug essentially retrofits a support cell into a sensory hair cell. I'm not sure if this will be functionally the exact same as well as the issue of depleting support cells.

If they have fantastic results, I will be happy to have been concerned needlessly about this, though and we do have one positive anecdote at least (friend of a friend who was supposedly in the trial) on this forum.

 

[grate_biff]

positive anecdote at least (friend of a friend who was supposedly in the trial) on this forum

I have thought a lot about that. Hope it´s true.

 

[xyz]

I don't know why people are not as hyped for this to be honest because if we see positive results for tinnitus in this then we will definitely see positive/better results from FX-322, too.

Are they going to tell us if tinnitus improved in the patients or no?

Tinnitus is listed as a secondary outcome measure of this trial. So probably we should know by 30.4.

 

[Lucifer]

I don't know why people are not as hyped for this to be honest because if we see positive results for tinnitus in this then we will definitely see positive/better results from FX-322, too.

Are they going to tell us if tinnitus improved in the patients or no?

Most likely if tinnitus was added in the Phase 2 trials.

Only a few of us are hyped up for this drug. Seems to be the drug that is most likely going to be released in the market first unless FX-322 can bypass their trials and release it in the market ASAP.

I would definitely choose FX-322 but I would choose Audion Therapeutics as a last option solution.

 

[d'Wooluf]

Lurking in brain is the thought that if they'd found *the* cure for hearing loss, they wouldn't wait 5 months to tell us. We'll know soon enough.

 

[FGG]

Lurking in brain is the thought that if they'd found *the* cure for hearing loss, they wouldn't wait 5 months to tell us. We'll know soon enough.

Reading FX-322's patent, it's clear there are some concerns with at least Novartis' method and it seems Audion, too:

http://appft.uspto.gov/netacgi/nph-...ncy+therapeutics"&RS="frequency+therapeutics"

The screenshot is of the most relevant part.

Overall, FX-322 seems to produce the same cell phenotype without depleting support cells. I'm a bit worried if the "hair cell like cells" produced by Audion by transducing support cells will function as well.

It's possible though that even a subpar signal (because who knows how relevant those differences clinically are) generated by these cells may help a lot with T but their trial is focusing on hearing loss and I don't think they will be nearly as strong as Frequency personally.