Member- Mar 16, 2015
- 200
- Tinnitus Since
- 12/2014
- Cause of Tinnitus
- Neuronmodulation suggests noise induced?
Autifony Therapeutics Phase II Study for AUT00063, for the Treatment of Hearing Loss and Tinnitus
- Thread starter attheedgeofscience
- Start date
"my reply said results end of this year" Results of the phase II trial end of this yes?
"if it works, market in 2 years" does it mean after phase III trial?
I would suggest taking a look at the drug approval timeline graphic on Wikipedia:
https://en.wikipedia.org/wiki/Drug_development
I would think at the very least there would need to be a phase III dosage study that last longer than a month before they could release the drug.
I think we are still at least three years away from general release.
https://en.wikipedia.org/wiki/Drug_development
I would think at the very least there would need to be a phase III dosage study that last longer than a month before they could release the drug.
I think we are still at least three years away from general release.
I think the info in the email from Autifony quoted by @Dubbyaman (and earlier by @111) should be treated as reliable and is the most authoritative source of information we have on the likely timescale for availability of AUT00063. That email says "3+ years after finishing this study" (by which they presumably mean the current Phase 2 trial) and talks about the results being available by mid-2016. So 3+ years after mid-2016 is mid-2019 or some time in 2020. I made my own enquiries to a member of Autifony's scientific advisory board and his opinion was consistent with this estimate.
People have been given different info. From what I've heard it won't be this long. Keep strong all. R
The thing is that a phase III can be done "on the market". In that case however if the drug shows adverse side effects it has to be pulled of the market immediately.
I think people are overly optimistic about this.
I believe the time it will take for anyone to walk in an ENT clinic and walk out with a AUT00063 prescription which will then be filled at a local pharmacy is about 5 years, if ever.
But of course it will be possible to get our hands on it before that depending on where phase III studies will be carried out and what the inclusion/exclusion criteria will be this time.
TexasT
Member
- Jul 31, 2015
- 18
- Tinnitus Since
- 01/2000 on and off....now severe
- Cause of Tinnitus
- Honestly don't know
So 3+ years if everything goes properly? I'm assuming that's for UK/Europe, what about the US? 
If FDA approval comes beyond that time frame, someone's going to have to put a brother up for a month to come over and get treatment lol..or maybe FedEx?
If FDA approval comes beyond that time frame, someone's going to have to put a brother up for a month to come over and get treatment lol..or maybe FedEx?
You don't really have to go to an ENT. Your GP could prescribe the pills for you. I'm confident that my GP would prescribe these pills for me the day they hit the market.
- Jan 3, 2015
- 635
- Tinnitus Since
- 04/21/2014
- Cause of Tinnitus
- Sensorineural hearing loss right ear.
Forget about timing issues, if 00063 doesn't work as expected, where are we then? Still ringing our heads off!
Why do you say that? How do you know it doesnt work or expected not to work? thanks
- Oct 13, 2014
- 46
- Tinnitus Since
- 07/2014
- Cause of Tinnitus
- Frequent viral infection ENT, loud music, BP sugar
He said IF. I think he meant that the timing issue isnt as important as the actual efficacy of the drug- as in if it wont work , we're f--ked...(some of us).
He neve
He never cured his T, he still has it to this day- but it is comparatively mild and unchanging and only in one ear. As far as I know...
- May 8, 2012
- 1,601
- Tinnitus Since
- 04/15/2012 or earlier?
- Cause of Tinnitus
- Most likely hearing loss
According to Kirk, he habituated. Or maybe he found a way to transport into the future and get Autifony. And now that Scottie and Spock have both passed away, he has no way to get back there to bring back more for the rest of us. You can't do it without your Chief Science Officer and Chief Engineer. http://www.howsyourhearing.org/AudiologyToday/ATWilliamShatner.html
- Jan 3, 2015
- 635
- Tinnitus Since
- 04/21/2014
- Cause of Tinnitus
- Sensorineural hearing loss right ear.
Shatner did TRT under Dr. Jastreboff. He claims it worked for him. Of course we don't know what level of T he had? Although he entertained suicide.
Dr John Hutchison joins Autifony Therapeutics as Chief Medical Officer
http://www.autifonytherapeutics.com/autifony-news.asp
http://www.autifonytherapeutics.com/autifony-news.asp
Dubbyaman
Member
That's an interesting question that I would like to know too. I imagine they would be able to change the dosing before phase three and continue with that but I'm guessing they wouldn't be able to change the actual compound without restarting the trials. But I'm just some guy so don't take my word for it.
Yes, if anyone can answer that question it could be benefit to this thread, because we are often off topic...
I hope this helps to explain clinical trail phases. They would not change the compound itself, but dosage would/could be modified. All phases are obviously important in proving the efficacy of a new medication, but on average, 70% of Phase I meds move on to Phase II. Once Phase II is complete, the percentage drops to 33% of meds moving on to Phase III, so PII is pretty darn vital. These are just averages across every med that has passed through the FDA, so take them as a guideline, and not specific to Aut063. Also keep in mind that there are vast numbers of meds that don't even reach Phase I let alone PII, so Aut063 is on a positive path.
- Phase I: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
- Phase II: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
- Phase III: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
- Phase IV: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.
Tnx for info,
Is there chance that med fails after phase III trial (suppose yes, mainly because of side effects, more than effectiveness) but, is there percent of how many drugs successful goes from phase III to phase IV (to market).
Sorry if I am boring, and asking too much.
Again thanks for information, I think that other members are also interested in this success %, and lets say kind of predictions...
It's roughly another 30% make it to phase 4. It pretty depends on side effects at that point, but could be efficacy as well. It all depends on the sample set success rate in P1. For example, if a med was 25% successful, P3 efficacy would be more at play than if P2 efficacy was 80%.
According to Figure 1 in this article http://www.nature.com/nbt/journal/v32/n1/full/nbt.2786.html (figures freely available though the article is not) and as noted above, the most challenging step is phase 2 to phase 3 with a success rate of about 33 percent. The Phase 3 to New Drug Application (NDA) success rate is about 66 percent. NDA to approval looks to be about 80-85%.
Taking these as given and assuming that a drug must go through all 4 of these steps, if we start with 100 drugs in phase 2, 33 will make it to phase 3, about 17 will make it to an NDA and 14 will be approved.
This page (http://www.fdareview.org/approval_process.shtml) has information on the drug approval process including the phase 3 to NDA to market steps.
(I also don't understand why Autifony's response to questions mentions the possibility of a second phase 2 trial and possibly more than 1 phase 3 trial - assuming I am remembering correctly.)
Taking these as given and assuming that a drug must go through all 4 of these steps, if we start with 100 drugs in phase 2, 33 will make it to phase 3, about 17 will make it to an NDA and 14 will be approved.
This page (http://www.fdareview.org/approval_process.shtml) has information on the drug approval process including the phase 3 to NDA to market steps.
(I also don't understand why Autifony's response to questions mentions the possibility of a second phase 2 trial and possibly more than 1 phase 3 trial - assuming I am remembering correctly.)
I like your percentages better
Perhaps if they do a P2b it'll be testing a higher dosage on a small sample set before moving on to a larger sample in P3? This is purely speculation, but the 800mg P2 dosage seems like it would be a minimum dosage. I only say that due to Keppra and Trobalt dosages being higher for full affect, both of which target potassium channels. Again, I have nothing that would back this up, it's merely a thought.
Theories aside, we'll know by Q2 next year what direction they're going.
Perhaps if they do a P2b it'll be testing a higher dosage on a small sample set before moving on to a larger sample in P3? This is purely speculation, but the 800mg P2 dosage seems like it would be a minimum dosage. I only say that due to Keppra and Trobalt dosages being higher for full affect, both of which target potassium channels. Again, I have nothing that would back this up, it's merely a thought.
Theories aside, we'll know by Q2 next year what direction they're going.
I think this drug has a pretty good chance. I communicated with a guy who had success with it on the trial and the side effects were nearly non-existent. It worked great on him, but his tinnitus went back up to where he started after he was off the drug. A pharmacist friend of mine told me the big concern the FDA has of new drugs is safety and not necessarily broad efficacy if there isn't alternative treatment.
I imagine future trials for the drug will focus on longer term usage to ensure it is safe over a longer period of time than a month. I do not believe they can dramatically change the dose moving to phase III, so another phase II trial with a different dose level may be performed.
I am rather surprised at the length of time it is taking to find enough participants for this short trial. If the drug shows promise I would imagine they would take this to a country with a larger patient pool to complete the study faster. They have a lot of money tied up in the drug and I am sure they are anxious to get it into the marketplace if it works.
I imagine future trials for the drug will focus on longer term usage to ensure it is safe over a longer period of time than a month. I do not believe they can dramatically change the dose moving to phase III, so another phase II trial with a different dose level may be performed.
I am rather surprised at the length of time it is taking to find enough participants for this short trial. If the drug shows promise I would imagine they would take this to a country with a larger patient pool to complete the study faster. They have a lot of money tied up in the drug and I am sure they are anxious to get it into the marketplace if it works.
SoulStation
Member
You're right that the study seems to be taking a long time due to a shortage of eligible participants but I don't think the size of the UK population is the problem here. The UK is the 22nd most populous nation on earth with 64.8 million people according to recent estimates. There should be enough suitable candidates out there and it is surprising that they are still recruiting even now, more than a year after the recruitment process began. It is possible that GPs and ENTs are not being pro-active enough in directing suitable candidates on to the trial. I would surmise that the reason for the slow progress is a combination of strict eligibility criteria and inadequate publicity.
I completely agree with PhilB. Publicity likely has a lot to do with the challenge in finding candidates. I'm sure there are a number of sufferers who would meet the criteria, who have no idea this trail exists. Obviously they're not testing it in the US, for T anyway, but the American T Association doesn't have a word about Aut's existence of their website or mailings. One would think they would at least make people aware of it?
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