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

Also on the preclinical side, Autifony has a relationship with the Ear Institute at University College London (UCL), where work on animal models is in progress currently. UCL is in the process of setting up a unit to carry out Phase I clinical trials of treatments for hearing disorders and Large said it is hoped they will collaborate on clinical development also. Within the scope of the 10 million first round funding the lead product will be progressed to the end of Phase I. Large said that the initial clinical studies will involve patients, meaning that it should be possible to get some early indications of efficacy.

Source: BioWorld International (August 24, 2011)
 
Do you think someone at Autifony has tried AUT00063 in real? I mean a test person with T to check if it's really working, before starting all the required trails.

I'm confident that Autifony is following the proper ethical and research guidelines for drug testing on human subjects…which I think we should all be happy about.

True, it sure would be nice to know that someone out there has already felt the joy of reduced (or even absent) T after taking AUT00063. However, I'm sure that there is a very strict protocol for this or any human drug study.

It really is a safety and liability issue. Imagine that someone at Autifony provided a T sufferer with AUT00063 before completing the animal model study or the non-T sufferer safety study. If, in a worst case scenario, something went horribly wrong for the patient after taking the drug, Autifony could be looking at a major lawsuit and further AUT00063 research would be shut down.

That being said, if I was having a coffee outside of the Autifony labs and one the researchers slipped a little AUT63 into my drink, I'd be chugging it like Gatorade! :LOL:
 
Since no one has stepped forward, I will try to get some proper information from the same source that I have used earlier on:

https://www.tinnitustalk.com/threads...ing-loss-and-tinnitus.6516/page-16#post-73170

However, for this kind of exercise, patients are (sometimes) better than researchers as the study is double-blind. I doubt I will get much information from a researcher during the early stage of a phase-II trial.

But I can try.

I have received a response from the source from earlier on. There is no new information to share about the trial at this point (too early); enrollment and screening is still in progress, I am told. I did get a link which is different from the NHS and EU links from earlier (and which I have already shared within this thread):

https://clinicaltrials.gov/ct2/show/NCT02315508?term=tinnitus&rank=85

The above link contains two e-mail addresses and telephone numbers in relation to staff from Autifony:
Contacts

Contact: Peter Harris, MD (00 44 7739 798 146 peter.harris@autifony.com)
Contact: Jeannette Watson (00 44 77026 75955 jeannette.watson@autifony.com)

It is the first time (ever) that I have seen telephone numbers listed for people from Autifony. Autifony has been "notorious" for not disclosing any contact details in relation to their staff (other than a basic e-mail address). But now they have.
 
I have received a response from the source from earlier on. There is no new information to share about the trial at this point (too early); enrollment and screening is still in progress, I am told. I did get a link which is different from the NHS and EU links from earlier (and which I have already shared within this thread):

https://clinicaltrials.gov/ct2/show/NCT02315508?term=tinnitus&rank=85

The above link contains two e-mail addresses and telephone numbers in relation to staff from Autifony:


It is the first time (ever) that I have seen telephone numbers listed for people from Autifony. Autifony has been "notorious" for not disclosing any contact details in relation to their staff (other than a basic e-mail address). But now they have.
If we call them do you think they will give us informations about the results ?
 
More information on the trial:
Locations

Birmingham University Hospital (**Recruiting**)
Birmingham, United Kingdom, B15 2WB
Contact + 44 121 414 9276

University College London Hospital NHS Foundation Trust (**Recruiting**)
London, United Kingdom, WC1E 6BT

Freeman Hospital (**Recruiting**)
Newcastle, United Kingdom, NE7 7DN
Contact +44 191 2139485

Salford Royal Hospital (**Recruiting**)
Salford, United Kingdom, M6 8HD
Contact +44 161 206 0534

Royal Hallamshire Hospital, Sheffield (**Recruiting**)
Sheffield, United Kingdom, S10 3BR, UK
Contact + 44 1142 261294 or

Shrewsbury and Telford Hospital NHS Trust (**Recruiting**)
Telford, United Kingdom, TF1 6TF

Wrightington Hospital (**Recruiting**)
Wigan, United Kingdom, WN6 9EP
Contact +44 1257 488264


Sponsors and Collaborators

Autifony Therapeutics Limited
University of Nottingham

InvestigatorsPrincipal Investigator: Jaydip Ray, MD Sheffield Teaching Hospitals NHS Trust

Source: https://clinicaltrials.gov/ct2/show/NCT02315508?term=tinnitus&rank=85
 
I have received a response from the source from earlier on. There is no new information to share about the trial at this point (too early); enrollment and screening is still in progress, I am told. I did get a link which is different from the NHS and EU links from earlier (and which I have already shared within this thread):

https://clinicaltrials.gov/ct2/show/NCT02315508?term=tinnitus&rank=85

The above link contains two e-mail addresses and telephone numbers in relation to staff from Autifony:


It is the first time (ever) that I have seen telephone numbers listed for people from Autifony. Autifony has been "notorious" for not disclosing any contact details in relation to their staff (other than a basic e-mail address). But now they have.
Thanks for trying to get some info, maybe we hear something soon.......some positive results hopefully!
 
Looking at that link for the clinical trial it appears to be a phase 2 a trial and not phase 1 as mentioned in the thread title

QUIET-1 study = QUest In Eliminating Tinnitus...

QUIET-1 Study.png
 
Looking at that link for the clinical trial it appears to be a phase 2 a trial and not phase 1 as mentioned in the thread title
Are you referring to the title quiet-1 study? I believe that's just the name of the study but the link does state phase 2.
 
who are behind autifony ?

Autifony was founded in 2011, as a spinout from GSK. It attracted a £10 million Series A funding round from SV Life Sciences and Imperial Innovations, which both invested £5 million in the company. GSK is a founder shareholder in the company. A second close of the Series A round in 2013 led to Pfizer Ventures and the International Biotechnology Trust becoming shareholders and brought the total raised to £15.75m.
 
I do not want to be pessimistic, but I fear that they are wrong in directing research. I read their publications about schizophrenia. This psychiatric illness, often people perceive, in addition to visual hallucinations and extreme states of euphoria / anger, they hear voices, footsteps, and more. So they warn acoustic hallucinations that science calls acousma. I hope that they know the distinction and complete different mechanism between the acousma (auditory perception of voices, footsteps etc) and tinnitus (phantom sound perception ) frequently related to hearing problems and not mental problems .
 
I hope that they know the distinction and complete different mechanism between the acousma (auditory perception of voices, footsteps etc) and tinnitus (phantom sound perception ) frequently related to hearing problems and not mental problems .

@Viking - I do not think we need to be worried about this. Autifony obviously believe that Kv3 potassium channel modulation is likely to have a useful function in the treatment of both tinnitus and schizophrenia. On their web site, they explain why they think that. Quoting from http://autifony.com/autifony-science.asp#schizophrenia:
"We have identified Kv3 potassium channels as new targets for the treatment of schizophrenia.Their importance lies in their role in the control of parvalbumin-positive (PV+) interneurons that are thought to be dysfunctional in schizophrenia (Lewis et al, 2012, Cortical parvalbumin interneurons and cognitive dysfunction in schizophrenia. Trends in Neurosciences, 35(1), 57-67). We propose that positive modulation of Kv3 channels will enhance PV+ interneuron function and thus reduce positive, negative, and cognitive symptoms of schizophrenia."

On the question of how they expect AUT000063 to affect tinnitus, Autifony are rather more vague.
"Studies to date confirm the importance of Kv3 channels at all levels of the auditory pathway. Profiling of our lead compound shows it can modulate function in both brainstem and cortex in ways that could be beneficial in the treatment of tinnitus."

To me, this does not imply that Autifony believe schizophrenia and tinnitus to be similar conditions or that they are incapable of differentiating between a neurological problem and a psychiatric illness. It just means that the same compound is expected to be helpful in treating both conditions.

Our (currently dormant and much-missed) forum-member @benryu offered the clearest explanation I have yet seen of how AUT00063 is expected to affect tinnitus. I notice that you agreed with the post below so let us continue to hope and believe that @benryu knew what he was talking about. :)
https://www.tinnitustalk.com/thread...-—-general-discussion.5074/page-17#post-58220
 
I do not want to be pessimistic, but I fear that they are wrong in directing research. I read their publications about schizophrenia. This psychiatric illness, often people perceive, in addition to visual hallucinations and extreme states of euphoria / anger, they hear voices, footsteps, and more. So they warn acoustic hallucinations that science calls acousma. I hope that they know the distinction and complete different mechanism between the acousma (auditory perception of voices, footsteps etc) and tinnitus (phantom sound perception ) frequently related to hearing problems and not mental problems .
Tinnitus actually is related in a way to schizophrenia.
The mechanism is very similar but the area of disfunction is quite different.
Schizo is disinhibition in the frontal cortex (or whatever) and tinnitus is in DCN/auditory brainstem (etc).
So worry not- they are on the right path.
 
Not a peep from these trials. Seems kind of strange. Has anyone seen anything on any other forums? I thought it was mentioned somewhere that one or two of the sites already started the trials.
 
Hi everyone - trying to get in on this trial as well. I've been in contact with UCL by email - they said they'd phone me in early January for pre-screening on the phone.

Wondering: for anyone who lives in London - I've just moved here and have noticed that the tube is SO loud. I wear 34db earplugs, otherwise it would be way too loud. Does anyone else catch the tube here and freak out that it might be making their T worse?
 
Hi everyone - trying to get in on this trial as well. I've been in contact with UCL by email - they said they'd phone me in early January for pre-screening on the phone.

Wondering: for anyone who lives in London - I've just moved here and have noticed that the tube is SO loud. I wear 34db earplugs, otherwise it would be way too loud. Does anyone else catch the tube here and freak out that it might be making their T worse?
That's great, I hope you get in, get the actual drug, get relief.....and update us. In that order :)
 
Hi everyone - trying to get in on this trial as well. I've been in contact with UCL by email - they said they'd phone me in early January for pre-screening on the phone.

Wondering: for anyone who lives in London - I've just moved here and have noticed that the tube is SO loud. I wear 34db earplugs, otherwise it would be way too loud. Does anyone else catch the tube here and freak out that it might be making their T worse?
I plug up down there every single time. It was loud before T.
 
Hi everyone - trying to get in on this trial as well. I've been in contact with UCL by email - they said they'd phone me in early January for pre-screening on the phone.

Wondering: for anyone who lives in London - I've just moved here and have noticed that the tube is SO loud. I wear 34db earplugs, otherwise it would be way too loud. Does anyone else catch the tube here and freak out that it might be making their T worse?
the trial is only for english people , as I see your location is hobart in tasmania (australia), are you an english people ?
 
@2131e the older tube carriages on the underground are so loud! I always wear my plugs when I travel.

Good luck getting on the trial.

P.S. What is that thing in your picture?!
 
As we await our first TT member to be accepted into the AUT00063 trial (good luck @2131e if it is you), I stumbled across an older article that may be of interest to those on this thread.

No, it isn't on new developments, promising research, or optimism from a neurologist - sorry.

Rather, I think this article (http://www.thelondontinnitustreatme...s-drug-research-news-now-with-added-spin.html) is a good example of (yet another) unique challenge T-sufferers have to deal with - tinnitus specialists who don't quite seem to "get it".

The article was written in 2013 by Jason Levy - an "Audiologist, Certified Tinnitus Practitioner, HCPC Registered Hearing Aid Dispenser and CNHC Registered Hypnotherapist". The article was written around the same time that AUT00063 was entering Phase 1 trials.

Although Levy makes a glib statement of encouragement - "Great, I thought. There'll soon be a cure for this horrible, debilitating condition," the majority of the article is spent either fostering fear that AUT63 will have terrible side effects or arguing that there are already "many effective treatments" (he offers hearings aids, mindfulness, and hypnotherapy as effective treatments).

I am willing to accept that those without T and those who do not work with T-sufferers may not understand how debilitating, maddening, and life-crushing T can be.

However, I have more difficulty with T-professionals (who are supposedly on our side) who seem to be satisfied with status-quo treatments (which are woefully short of offering genuine symptom reduction)…and those who would rather instill fear of the first ever targeted drug treatment for T!

Yes, I understand that AUT63 may not be as effective as we hope and that it may have side effects. But seriously, should this be our approach to discovering new treatments for medical conditions? If we already have something that "kind of, sort of helps some people" and new treatments could be scary…then we shouldn't bother? This is not how medical breakthroughs and more effective treatments arise.

I realize that the author may only be playing devil's advocate and may be intending to keep us T-sufferers grounded in reality. But frankly, T does an excellent job all by itself keeping me grounded.

And wouldn't it be refreshing to (just once) hear from an audiologist or ENT who allows him or herself to be just a bit excited about the possibility a game-changing treatment for T?

Rant over. Stay positive everyone!
 
The blog entry written by Jason Levy is narrow-minded and quite simply, idiotic. I hope everyone who reads it votes it one star at the bottom of the page.

If AUT63 cures or helps everyone with tinnitus, he'll be on the dole.
 
Although Levy makes a glib statement of encouragement - "Great, I thought. There'll soon be a cure for this horrible, debilitating condition," the majority of the article is spent either fostering fear that AUT63 will have terrible side effects or arguing that there are already "many effective treatments" (he offers hearings aids, mindfulness, and hypnotherapy as effective treatments).

Don't know who he is. Which most likely means he is not very important.

But one day there will no longer be a need for two-thirds of his shop's content. Which will leave him teaching evening classes on audiology based principles from the 1970s and acting as a "prostitute" for the hearing aid companies and their future rapidly declining sales and market shares. A suitable reward for any member of the medical community who displays a status quo attitude towards patients' needs and health.
 
I sure people like him scoffed at the notion of laser beams treating eye conditions.

Unnecessary. There are already "many effective treatments" for vision problems such as squinting, standing closer to objects you want to see, and eating lots of carrots.

In my professional opinion, these treatments are good enough.

RoadToSilence, R.C.D., C.P.S.C.
(Registered Carrot Dispenser and Certified Professional Squinting Coach)
 

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