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

I assume you might have to take it all your life, but it seems more like vitamins for the brain than a drug. Based on salts (?). seems pretty harmless. I don`t think it will influence hormone balances and stuff like that. More like a little piece of the mineral body of the brain that is missing??

 

I really hope that cure for tinnitus is going to be some pill or injection like AM-101 and not any surgery.. Like brain surgery sounds little too scary for me!

 

Would be nice if it was a pill or injection... But im sure if the opportunity was a 100 % cure rate with brain surgey.. Then everyone would be jumping through that dooor!!! Lol

 

I think surgery is normally the last resort, therefore only done when there is no other way around. Unless you belong to the 1% of people who are disabled by tinnitus, I dont think doctors are going to do that. Probably most of us will benefit from a combined treatment: some drug + TRT.

 

Depends on outcomes, I would imagine.. side effects, if the compound is already used in some manner, I have a friend whos family member works for a big drug company as a research scientist, he says its easier and fast to test new drugs in Europe than the U.S..... so if they do plan on testing, I hope they move it to Europe, to speed results..... or my Canadian brothers...

 

My dad works for GlaxoSmith, i`m gonna find out if he knows people that know people to get some info on the trials.

 

Outstanding man!
Salt or no salt fact is it cured all dem mice.

 

Autifony is conducting their clinical trials through the UCL in London. I would imagine you have to contact them if you would like to inquire about the trial.

 

Best case scenario, when can i take this pill?

 

They just finished they first trial which is still very early stages. Depending on the country probably 4-5 years best scenario. But more realistlic is probably 6-7 years. Also we dont even know if it works so never sounds also pretty realistic.

 

How do you know they just finished the trial ?

 

They started it in May 2013 and promised to give out the results in the first quarter of 2014 which is in March or April. So I suppose they are done but haven't given out the results out. Also, a few pages back on this thread some wrote them an email and they said they would start Phase II this year. I dont know though if they are going to do Phase IIa and IIb or only II... So I assumed if a phase takes a year and there are 4 phases left that leaves as with 4-5 years

 

Old news, but relevant...
http://m.foxbusiness.com/quickPage.html?page=32811&content=55416482&pageNum=-1

LONDON -(Dow Jones)- GlaxoSmithKline PLC (GSK.LN), the drug giant, Monday announced that its wholly-owned subsidiary Glaxo Group Limited, or GSK, will receive a 25.4% minority equity stake, representing a GBP1,250,000 investment, in Autifony Therapeutics Limited, a U.K.-based biotechnology start up created through a funding round of up to GBP10 million alongside investors Imperial Innovations and SV Life Sciences.
MAIN FACTS:
-Under the terms of the agreement, Autifony will issue 850,000 A ordinary shares to GSK in exchange for a number of pre-candidate voltage-gated ion channel modulator compounds and associated patent applications and data for development in hearing loss, as well as 571,429 Series A preferred shares in recognition of GBP400,000 worth of development work funded by GSK on behalf of Autifony.
-GSK will also be eligible to receive a further 550,000 A ordinary shares on achievement of a pre-determined milestone, at which time there will be a further investment by the existing consortium and GSK will then own 13.2% of Autifony on a fully diluted basis.
-GlaxoSmithKline PLC shares closed Friday at GBP12.43 valuing the company at GBP63.22 billion.
Copyright © 2011 Dow Jones Newswires

 

Also I like to add this bit of text as a reminder how significant this project is for Chronic T sufferers.


Kv3.1 channels are voltage-gated potassium channels that enable fast repolarization of the neuronal action potential, and are essential for the high frequency, high fidelity firing of neurons in the auditory brainstem and midbrain . Altered activity of these neurons has been implicated in the generation of tinnitus induced by noise exposure . Furthermore, loss of Kv3channel function has been observed shortly after noise exposure , which may contribute to the ma ladaptive plasticity leading to the emergence of tinnitus. In t he current study, 20 Long Evans rats (and 10 sham controls) were exposed to a unilateral 116 dB, 16 kHz octave- band noise for one hour in order to induce temporary hearing loss and chronic tinnitus . Thirty days after the noise exposure, a subset of approximately half of the noise - exposed rats demonstrated deficits in auditory gap processing, consistent with the presence of tinnitus. All 30 rats were administered 30 and 60 mg/kg of AUT3 (a Kv 3.1 positive modulator) and vehicle in a counterbalanced order, with 48 -hours washout between treatments. Both the 30 and 60 mg/kg doses of AUT3 abolished evidence of tinnitus, while the drug had no effect on the behavior of control animals or noise - exposed animals without tinnitus. These results suggest that AUT3 has potential in the treatment of chronic tinnitus associated with noise - induced hearingloss.

 

If they said they will start a phase II, that means phase I must have been pretty successful?

 

Phase I just means trying the drug on healthy patients in order to see side-effects. Probably just means they were not too bad However I think they only had around 50-60 "guinea-pigs".

 

Thank you Nills.
Also I'd like to add that a similar drug we have right now is Trileptal and Tegretol. They have cured/diminshed tinnitus in some patients as well. However they are not effective in many cases and have a bad side effect profile.
As I understand it these drugs act on sodium channels. Since kv3 potassium channels dominate in the auditory pathways, it is a much more likely to succeed....thoughts?

Mechanisms of action of Trileptal
The mechanism of action of action of oxcarbazepine (Trileptal) is similar to that of carbamazepine.
Oxcarbazepine and its active metabolite, monohydroxy derivative (MHD), have effects on sodium channels and possibly potassium and calcium channels. Neither oxcarbazepine nor MHD has an effect at binding sites for GABA or other neurotransmitter receptors.
http://professionals.epilepsy.com/medications/p_trileptal_mechanism.html

 

If a side effect is hair loss, will this be permanent? I will look like an animal if I lose my hair, not even that, I'd just look like a... thing... Obviously tinnitus doesn't sound like a big problem if I'd rather have the T than my hair, but seriously, I need my hair. I'd easily give up a toe or some years of my life though.

 

Why do you think hair loss is a side effect?

 

It came up when I googled on of the drugs, but doesn't seem normal for the drug. This was all I found now

http://www.rxlist.com/script/main/rxlist_view_comments.asp?drug=trileptal&questionid=fdb5005_pid

 

It is not listed on the side effects. Sure everyones body is different but it doesnt seem very common. Also, this is not the same drug autifony is working on. Its another one and unless you have eplilepsy you wont need that. But hey maybe our teeth will fall out due the drug that Autifony is working on

 

I wouldn't mind that at all, my teeth suck. But maybe using fake teeth (what's the word for a set of fake teeth that grampa uses in the simpsons? "Gum"?) isn't that fun maybe. But better than T I'm sure

 

The Phase I studies should be released by the end of March or April, right?

Phase II is when you can start having hope that maybe it will do something.

 

yes in the 1st quarter

 

Just to clarify Erlend- Stina is right, those drugs I mentioned are not the same as Autifony.
Autifony is going to act specifically on auditory channel gates.

 

That's when you might be able to back up your hope rationally, but we can hope already!

 

If autofony is only 3 years behind AM101 I might have to reconsider my plan here.. Hmm.

I suppose am101 + autofony would be jackpot, but then again, if something goes wrong in am101 that would be bitter...

 

I agree. I guess I don't want people to get their hope up beyond a point when it's possible that it could bomb in Phase II because the amount needed produces too many side effects or it's just not effective period. Like wise in Phase III.

 

This piece of text may shed some light on the question if we have to keep taking it for longer periods of time or not ...

Safety, blood levels and effects of AUT00063: first doses in humans;v1
REC Name
Scotland A REC
REC reference
13/SS/0035
Title
Safety, blood levels and effects of AUT00063: first doses in humans;v1
Contact name
Dr Gary Peters
Contact email
vparker@hmrlondon.com
Research summary
AUT00063 (the study medicine) is an experimental new medicine for treating hearing problems, such as loss of hearing or tinnitus (a buzzing noise in the ears). Hearing problems are common in older people and have become more common in young people. There are currently no medicines available for them. Hearing loss has been linked to reduced activity at certain sites in the brain. We hope that the study medicine increases the activity at those sites. In this 2-part study (Parts A and B), we aim to assess side effects, blood levels, and effects of the study medicine.In Part A, We'll give up to 24 healthy young men, aged 18??45 years, up to 5 single doses of the study medicine by mouth. It??s never been given to humans before, so We'll start with a small dose, and increase the dose as the study progresses. Participants will take up to 15 weeks to finish the study. They??ll make up to 7 outpatient visits, and stay on the ward for up to 15 nights in total (up to 5 stays: 3 nights each).In Part B, We'll give 24 healthy young men, aged 18??45 years, and 18 older men and women, aged 60??75 years, daily doses of the study medicine for up to 28 days. Participants will take up to 10 weeks to finish the study. They??ll make up to 4 outpatient visits, and stay on the ward 15??29 nights in a row, depending on how long we expect it to take until blood levels of the study medicine level off. A pharmaceutical company (Autifony Therapeutics Limited) is funding the study.The study will take place in 1 centre in London. We'll recruit participants by: advertising (newspaper, radio, and websites); word of mouth; volunteer databases; and our websites.

http://www.nres.nhs.uk/researchsummaries/?entryid29=174756&p=2194

 

hey all im new to this forum but have been following this thread about autifony with great interest over the last couple of weeks any info of its success or how it works as I might be able to take part in phase 2 trials as my audiologist is an audiological scientist for ucl who takes part with clinical trials there thanks