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

[PhilB]

Though still not much closer to being accepted onto the AUT00063 trial, I have now received a "Participant Information Sheet". I do not know if any of this will be regarded as new but the information below is taken from the factsheet. Text in bold is directly quoted, text not in bold is my own comments or summarising of the info in the document.

* Reduced activity at certain sites in the brain (called "voltage-gated potassium channels") has been linked to hearing problems....AUT00063 is an experimental new medicine that has been developed to improve the action of these specific channels and so treat the brain component of these hearing problems.

* Subjects have taken the drug for only 21 days so far (presumably in Phase 1), whereas in this study (Phase 2a) subjects will take the drug for 28 days.

* Subjects up to the age of 45 years have received doses of up to 800mg daily...older subjects aged 61-75 years were given a maximum dose of 600mg daily (in Phase 1). This was to be more cautious in case elderly subjects were more sensitive to the drug. In the study, it did not appear that elderly subjects were more sensitive. Hence in this study (Phase 2a), all subjects at whatever age will be given 800mg daily.

* Safety will be determined by looking at a number of assessments (physical examinations, blood sampling, hearing assessments, questionnaires, etc.)

* People on antidepressants do not seem to be explicitly ruled out but "it would be preferable if brain acting medication was avoided while you were on the study".

* Caution is urged when driving or sunbathing. Exposure to "potentially damaging noise levels" is discouraged. Food or drink containing grapefruit will not be allowed. No explanation is given for the necessity of avoiding grapefruit.

* Participants will be required to visit the clinic 5 times. At the screening examination, they will undergo a complete phyical examination including ECG, blood and urine tests. "In some centres, some patients will undergo additional optional brain encephalography (EEG) and/or auditory brain response (ABR) tests."

* The most common side effects that were noted by participants (in Phase 1)...were mostly mild in nature and included headache, feeling a bit sleepy or tired, feeling a bit nauseous. At most, about 1 in 10 subjects felt these effects. Also, 4 study subjects out of 56 who received the study medicine, showed abnormal events on the heart rhythms which did not cause any symptoms. Heart experts reviewed the data and confirmed that these events were not a clinical worry and could not be proven to be related to the drug."

 

[Silvine]

Grapefruit juice interacts with some calcium channel blockers and is known to increase the blood levels of certain medications. I guess if they're doing blood sampling to check for metabolites to see how your liver is dealing with the dosage they don't want it being skewed with it being a trial.

 

[valeri]

Now we just hope that it does what it's suppose to do!

 

[Silvine]

There's nothing showing any results on the Clinical trails register yet https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-002179-27

Bear in mind it's a double blind placebo criteria study and these things take time. The first indicator of success will be a huge jump in the share price. If this medication works then Autofony are going to make serious amounts of money. I doubt there's anyone on here who wouldn't pay a years salary for it.

 

[Hudson]

There's nothing showing any results on the Clinical trails register yet https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-002179-27

Bear in mind it's a double blind placebo criteria study and these things take time. The first indicator of success will be a huge jump in the share price. If this medication works then Autofony are going to make serious amounts of money. I doubt there's anyone on here who wouldn't pay a years salary for it.

Is Autifony listed on any stock exchanges? I don't think it's a publicly offered company yet. Auris Medical and GenVec are, however.

 

[Silvine]

It's privately funded but it's biggest investors are.

SV Life Sciences http://www.svlsa.com/
Imperial innovations http://www.imperialinnovations.co.uk/
Pfizer venture investments http://www.pfizer.com/partnering/areas_of_interest/venture_investments

Do we have a financial analyst on TT anywhere?

 

[lapidus]

Do we have a financial analyst on TT anywhere?

Yes, @attheedgeofscience

 

[attheedgeofscience]

Is Autifony listed on any stock exchanges?

I covered this topic a while back.

https://www.tinnitustalk.com/thread...-—-general-discussion.5074/page-15#post-58033

I don't think it's a publicly offered company yet. Auris Medical and GenVec are, however.

Yes. And so is Otonomy Inc...

 

[tshapiro]

Should AUT00063 work as hoped...
- Will you need to take it for a short term while it addresses T (i.e. 2 weeks) or will it be a lifetime of taking the drug?
- When would it realistically be available for us to use?

 

[dan]

Should AUT00063 work as hoped...
- Will you need to take it for a short term while it addresses T (i.e. 2 weeks) or will it be a lifetime of taking the drug?
- When would it realistically be available for us to use?

-they don't know.
-they don't know.

 

[tshapiro]

-they don't know.
-they don't know.

- Well, I suppose these drug testing phases have a normal course of running if things go well. I'm just looking to understand what would be typical.
- I'm supposing if there is a theory for why it could work than the mechanisms behind that theory could also be used at deriving the suspected protocol.

So, if someone with knowledge in this area would mind posting their thoughts on it that would be nice.

 

[Martin69]

Why is it so difficult getting any news from AUT00063?
You can read each and every piece of information anywhere.
But nothing from this drug. Is there really no one from the TT forum on the trials?
Unbelievable for me.

 

[attheedgeofscience]

Why is it so difficult getting any news from AUT00063?
You can read each and every piece of information anywhere.
But nothing from this drug. Is there really no one from the TT forum on the trials?
Unbelievable for me.

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/thread...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.

 

[Silvine]

No news is good news, considering what a moneyspinner this could be if it's successful, I'm not surprised it's being kept wire tight. If there are people from TT involved in the trial they will have signed strict non disclosure agreements. If you were on it and it was working would you risk being thrown off for telling everyone? As much as I love you all that's a hell of a risk for what will become common knowledge next year.

 

[PhilB]

If there are people from TT involved in the trial they will have signed strict non disclosure agreements.

@Silvine, I think you may be jumping to conclusions here. When I spoke to Salford Royal on Wednesday, they told me that I can expect to be invited in for a screening appointment in early January 2015 and they told me that I am the first person to be given an appointment for screening at Salford.
A little while ago, @mcgregor said that he has attended a screening appointment at one of the hospitals (I don't think he told us which one) but he was deemed unsuitable due to not meeting their requirements for hearing loss. So it appears that some of the other hospitals are moving ahead more quickly than Salford but only 152 people in total are being recruited for this trial. A few weeks ago, @amandine was told by Wigan that they have already begun to administer the drug to trialees but we really have no idea how far the trial has progressed at the other hospitals and we do not know how many people are already taking AUT00063. It may not be very many.

If I get a screening appointment in the New Year, I will ask them about whether I am allowed to share my experiences with the forum. And if I get on to the trial but am forbidden from discussing it here, then at least I will tell you that I am not allowed to tell you anything.

 

[dan]

@PhilB - how severe is your tinnitus?

 

[Silvine]

My optimism is getting the better of me haha. My logic is that there are a lot of people from the UK on this forum who would jump at a chance on this trial yet we have no word from anyone at all? I appreciate that a lot of the trialees will have been referred or informed about it by their GP. But surely some of those would have been members of TT.

Hope you get accepted Phil, keep us informed.

 

[marqualler]

I think I know the answer to this question (i.e. "We don't know yet) but are there any plans for future trials in the USA? Hopefully if this Phase IIa is successful? The trial manager for AM-101 I spoke with said they only handle Phase III trials and had not heard about Autifony until I told her about it. I also emailed info@autifony.com and I imagine my email ended up something like this:

 

[PhilB]

@PhilB - how severe is your tinnitus?

@dan - I would describe it as between 4/10 and 6/10. Like many of us, I have good days and bad days but I have more good days now than I did in the early stages.

 

[dan]

@dan - I would describe it as between 4/10 and 6/10. Like many of us, I have good days and bad days but I have more good days now than I did in the early stages.

and you have hearing loss between 25-60 dB and your T is 6-18months old??

 

[PhilB]

and you have hearing loss between 25-60 dB and your T is 6-18months old?

@dan - My T began in early December 2013 so just over 12 months ago. I have some hearing loss in the region of 8khz, particularly in my right ear. I do not know if my hearing loss is between 25-60db. I expect the screening appointment will determine whether my hearing loss is within the range that they are seeking for this trial. I will let you know how it goes.

 

[preslys]

Why is it so difficult getting any news from AUT00063

serious laboratories do their studies in secret

 

[Hudson]

serious laboratories do their studies in secret

Truth. Intellectual property theft is common in academia and especially common in industry. If you have a novel mode of treatment, it is to your benefit to hoard that knowledge and be the first to discover.

 

[tom1989]

Truth. Intellectual property theft is common in academia and especially common in industry. If you have a novel mode of treatment, it is to your benefit to hoard that knowledge and be the first to discover.

At what stage do drugs tend to get patented? If it's patented then I believe they'll have to disclosure the name of the compound?

 

[DebInAustralia]

Is this a new compound?

 

[attheedgeofscience]

At what stage do drugs tend to get patented? If it's patented then I believe they'll have to disclosure the name of the compound?

http://www.faqs.org/patents/app/20130267510

http://www.autifonytherapeutics.com/publications/Turneretal2013-TRI_final.pdf

http://www.autifony.com/autifony-science-publications.asp

 

[Raindance74]

I've taken three psychoactive drugs in the past and all of them have had instant positive results. (Adderall since I was a teen, Xanax for flying anxiety, and I was prescribed Vicodin in college after a car accident). In each case, there was never any doubt they were effective as they kicked in immediately. I hope Autifony or whomever develops a medicine for tinnitus makes something thats effective on the spot and not like antidepressants which I hear take 6-8 weeks to fully kick-in.

 

[xanaxvictim]

I've taken three psychoactive drugs in the past and all of them have had instant positive results. (Adderall since I was a teen, Xanax for flying anxiety, and I was prescribed Vicodin in college after a car accident). In each case, there was never any doubt they were effective as they kicked in immediately. I hope Autifony or whomever develops a medicine for tinnitus makes something thats effective on the spot and not like antidepressants which I hear take 6-8 weeks to fully kick-in.

I only wish that AUT is successful and won't lose its efficiency after a short while like RTG apparently does

 

[Raindance74]

I only wish that AUT is successful and won't lose its efficiency after a short while like RTG apparently does

You're absolutely right, I never thought about it but all the drugs I listed can definitely build a tolerance and lose their efficiency after a while. I hope the tinnitus drugs dont do that!

 

[Freddie]

Freddie, would you keep us posted. I know the UCL location and instructions seem a bit vague. I might be interested in having a go, if they somehow become more relaxed on the average hearing loss, which judging by the posts on here may be a possibility. Cheers.

Hello there Lisa sorry for a delayed reply but I wanted you to know that I did in the end manage to talk with someone at UCL, they require a referral from your GP, I actually managed to get an email address so I then checked if they received the letter which they did and their last conversation with me was that they will be I touch in January regarding an initial screening.

Just before the UCL details came up I was in touch with the hospital in Birmingham and they actually rang me with a specific appointment in early January which I accepted but ideally I would rather go to UCL as living and working in the London area is far easier for me so at the moment I am a little bit torn as I don't want to cancel the Birmingham APPT then find out that UCL don't get in touch with me as they said they would but whatever way it goes at least I have got somewhere, how about you have you had any success in getting in touch .?

Best wishes.