Audion Therapeutics Trial

Recruitment starts in September so they probably won't be any news until then

 

Is this for safety trial?

 

Your question is answered in the very first paragraph of the very first post of the topic.

Both safety and efficacy.

 

http://cordis.europa.eu/project/rcn/193313_en.html

Who's applying

 

You know Frequency TX will be watching this Audion trial very closely since their hearing restoration drug is based on the same premise. If Audion's trials are successful, there's even more hope for Frequency's solution!

 

I would imagine because their primary target outcome is treating hearing loss, they would not want their outcome to be measured by a change in tinnitus severity. Remember that hair cell damage due to hearing loss is only a theory to why tinnitus occurs yet a very strong theory indeed.

I wish you all the best though, I do hope that applicants will report their progress on this board.

 

I wonder if they don't aspire candidates that regard tinnitus as their biggest problem because of possible anxiety issues?

 

Tinnitus patients are quite unreliable, it's a subjective condition and the only way to measure it is through a visual analogue scale.

Look at the conflicting reports for LLLT, how can one for example measure a 20% decrease in tinnitus and put in down to a certain treatment.

 

So Phase 1 and Phase 2 will be in 2017, and data will come out January 2020.
If everything goes well phase 3 will start after 2020 ?

 

Phase one and two both identifying the safety and efficacy in 2017 and according to the paper I saw results to be published in 2020.

 

@Samir You have to understand that it's a hearing loss trial, not a tinnitus trial. They want to know if their drug can restore hearing, not if it can lower or cure tinnitus (though it's a secondary outcome and will be monitored during the study).

 

didn't frequencies founder state tho that they are assuming it should work for tinnitus as they are fixing the root cause

 

The Leviathan said it might work if your tinnitus is caused by dead hair cells.



I believe this is why tinnitus is a secondary outcome for Audion. They probably think their drug may affect tinnitus, so they're gonna monitor it, too, during the hearing loss trial.

 

It's at least good news that it's a secondary outcome and they will report if any effect. Personally prefer to be tinnitus free than a mild hearing loss.

 

Good question. Although they haven't really excluded tinnitus patients from their trial, they just don't want that to be their first complaint.

 

Participants are allowed to have tinnitus, but it can't be their main complaint. If they do have tinnitus, it will be somehow monitored.

From the trial site:

Participant exclusion criteria
1. Presenting with a primary complaint of tinnitus
[...]

Secondary outcome measures
[...]
3. Tinnitus measured using a questionnaire at visit one, two and three

"As this is the first time the drug is tested in humans, it is not clear what the exact risks will be, but specific functions like hearing and tinnitus, balance, facial nerve function and taste are monitored closely for any changes throughout the study."

 

Crazy to think that after all these years of talk of regenerating hair cells they are finally moving into the clinic in the next couple of months or so. This will be a major breakthrough if successful. Even more major if it helps tinnitus. To think it was once considered permanent to lose them and now there is hope that this may not be the case!!

 

Why would it take 3 years for the results of the first 2 trials to come in? That seems like an insanely long time to me!

 

Way too long!

 

It's two phases. Phases can be whatever the researchers want or need them to be. Generally, not always, phases can take one to one and a half years. So three years is about right. But I share your frustration and impatience!

 

As someone without hearing loss and generally good hearing, but suffers with tinnitus, should I be excited about this?

I don't want to hope for something that will not benefit me, although I hope the best for you lovely people.

 

You list your T cause as "Noise", which means your hearing apparatus is probably somewhat damaged from that noise, possibly to the point of being a contributing factor to your T. Not all damage in hearing can be measured (basically, it's currently impossible to claim "I have no hearing loss" - but you could say "I have no measured hearing loss": remember that absence of evidence isn't evidence of absence), so it is possible that treatments that enhance hearing abilities on people with hearing loss would be beneficial to you, in addition to having a chance at addressing your T.

 

My hearing loss is a problem but I won't apply : Audion's trial will leave you with fewer (or no) supporting cells left. I want to be able to apply to Frequency's, which targets a more conservative approach. If Frequency fails and Audion succeeds, I'll still be able to benefit from Audion's drug, which will be closer to the market then.