Autifony Therapeutics Phase I Study for AUT00063, for the Treatment of Hearing Loss and Tinnitus

[lapidus]

@lapidus - was there any info that went out about how long Phase 2 would normally take? I'm just trying to determine a timeline here. Does anyone recall how long it was from when phase 1 completed to when phase 2 will start in October? According to an auto reply i received from Dr. Charles Large, he stated that if the phase 2 trial is successful they plan to extend it to US for further studies. I'm wondering if successful, we might see trials in the US by end of 2015, or am i being way too hopeful?

No, there is no detailed info about the length of the trial yet. I'm just guessing it will take at least 6 months since the drug might need some time to work and they would want to see how the drug works in the long run etc. Don't know how long phase 1 was exactly but that info might be here in this thread. But phase 1 was only to determine the safety so I figure phase 2 will be longer. They are about to relase new info on their website soon, so hopefully we get some more answers then.

 

[Grace]

What is up with autifony? No news yet when they plan on startin?

 

[Rube]

What is up with autifony? No news yet when they plan on startin?

I emailed them to ask, the reply from Dr. Charles Large said they planned to start phase 2 in October. Here is there canned response from Sept 5th:

Dear,
Thank you for your email and your interest in Autifony's clinical trial of AUT00063 for tinnitus. We have received a number of contacts regarding this trial, and I want to ensure that I can respond personally to each one. Autifony's UK trial is planned to start in October this year and will involve a number of UK sites. More information about the trial will be made available via Autifony's web site in the next few weeks. Please do check back with the website at that time. We are not currently planning studies in the US, but if the first trial is successfull then I hope we will extend to the US for further studies.

My best regards,

Charles Large

 

[NetroPhil]

What's the range for this new drug then? A year? Two years? Do we know?

 

[Rube]

from the autifony site:
Autifony have developed a novel drug, AUT00063, that may help to treat people with some types of tinnitus, in particular tinnitus associated with hearing loss following noise exposure or ageing.
does that mean it wont help any other reasons associated with tinnitus?

 

[Champ]

from the autifony site:
Autifony have developed a novel drug, AUT00063, that may help to treat people with some types of tinnitus, in particular tinnitus associated with hearing loss following noise exposure or ageing.
does that mean it wont help any other reasons associated with tinnitus?

I'm assuming this includes all inner ear damage related tinnitus causes (ototoxic meds, noise damage, etc.). It doesn't cover nerve damage or brain injury related tinnitus (which you could get from multiple concussions).

 

[Tinnitus Talk]

Further posts about the Autifony Phase 2 QUIET-1 study can go here:

https://www.tinnitustalk.com/thread...-treatment-of-hearing-loss-and-tinnitus.6516/