AM-101 Clinical Trial — Participants Updates and Discussion

@Elgringo32 , I didn't take the risks seriously into account before injection ... I was doing very well with my tinnitus . .. I forgot the suffering and what the amount of stress that tinnitus did to me ... so I went to this injection just to try to kill the 5 % of the rest of my tinnitus .... now , I am suffering with this worsening or whatever you call it and feeling so stupid that I have participate into this study

Don't worry about the post injection spike, it will go away. The majority of participants here experienced the same thing. Sometimes it takes longer sometimes less, but it should return to at least baseline for you.
 
This trial seems to be closed down now, even in Europe? Does anyone have a contact or number I can call to try and get myself in? My T is only 2 months old but I figure by the time this next becomes available I will be past my acute stage.
 
I've been in contact with them. Looks like the trial is definitely over. No new applicants will be accepted from any country. Oh well... from what I read on this forum it wasn't exactly helping most people that much anyhow. Still might have liked to have tried it.
 
Trial(Completed):
AM-101 initial trial

Base T the day/week before AM-101 trial injections:
Left ear:
3/10
Right ear: 1/10

1 week update
2 weeks update
1 month update
2 months update

Results from AM-101 initial trial: I noticed a significant improvement immediately beginning with week 1. By the end of week 4 after injections I was having regular days or half-days of silence, as many as 4 that week, and lower T overall. After that they became more rare over the past 2 months, with 1-2 days of silence a week leading up to the following trial but my T held at lower levels on average.


Trial(Active):
AMPACT/Open Label Round 1

1 week update
2 weeks update:

Date of initial T Onset:
1/21/2016

Cause:
Noise induced. Ear buds. Prolonged session of producing music in FL studio.

Base T the day/week before AMPACT injections:
Left ear: 0-3
Right ear: 0-1


Tinnitus description before injections:
After the initial AM-101 trial, I ended up with fleeting T ranging below my baseline, and random days of silence. I noticed the best frequency of silent days was towards the end of the first month. By month 3, before this round of injections, they settled at around 1-2 days of silence a week.

Date of injections:
5/27/2016-5/29/2016, 4 months since onset

Have you felt any change/improvement/worsening since the injections?
Yes. Not sure. No.

Not much change since week 1. I had another day of silence 2 days ago, and it continued to fluctuate between a 1-2, with it getting up to almost a 3/10 on a couple of days, and slightly higher frequency at times. Since I was already averaging 1-2 days of silence before the injections, I still can't say I noticed a significant difference so far from before the injections.

Current T severity and average T severity over the past week:

Current:
0.5/10. Having a very low day today but not complete silence.

Average over the past week: 1.5

Have you experienced any lasting (side) effects from the procedure?
No. My ear drums healed up fine. Eye check was also ok. My muffled right ear is pretty much completely clear, though I did notice it come back this past Wednesday after doing some heavy exercising. I haven't experienced it since.

Will you participate in the next round?
My feeling on this has not changed since last week. Only if I notice another significant improvement like I did from the first round, but so far it's been the same. Based on the results I'm seeing so far, I'm leaning more towards not likely but it's still early. I am curious to see how it's going to be at my 1 month update since that was when I experienced the most improvement during the first round of injections.
 
With regards to the next time this drug might be available to people, this is what Auris has to say: First we need to see and assess the data from the phase 3 program (due in August and November). At this point we have no plans for launching another trial.

So it's been 2 months since my T onset. I figure it's possible that they will have something out before my one year mark, but unlikely. Of course, who knows, maybe they will eventually decide that the drug is useful after the first year.
 

A bit overdue, but better late than never.

Overview of past updates:
24 hours after last injections
1 week after last injections
3 week after last injections (unplanned)
1 month after last injections
2 months after last injections
3 months after last injections


Will keep this one fairly short.
As outlined in my previous post, the development after the last injections was not very positive for 4 weeks in a row, except a few quite days in week #2 and few good days in between:

First week: Much worse (+200%)
Second week: Better (-50%)
Third week: Worse (+50%)
Fourth week: Worse (+50%)
Fifth week: Better (-30%)
Currently: Better (-30%)

By now, I would say that I am almost back to baseline, but currently the good days are more numerous than prior to the injections.
Generally speaking I think that the good days are slightly better and the bad days are slightly worse. Outdoors environment are still worse than before, but it's pretty close to where we started at. Bottom line is that I am recovering quite well, especially looking at the complications I experienced.

The injury of my eardrum has recovered well, and my hearing is impeccable, as it was before.

BUT unfortunately it is not all jolly good yet. Since exactly 8 days, I have had a very low hum in my right ear (complimentary to morse-like sound I got after the TACTT3 in my left ear, which has also returned). It doesn't bother me during daytime, but is quite intrusive when it gets quiet in the evening and mornings. I have not had any of this before and am quite sure that it is directly related to the trial. Hope it goes away again soon...

Will keep you posted on the development.
Good luck to all the other participants. We are all in the same boat, so hang in there, it will turn out well :)
 
Jefferies Securities write-up following the Auris Medical conference on June 9 in NYC

Management remains confident that TACTT2 trial (rd out exp Aug) will be sufficient for FDA, due to SPA apprvl. Further, '101 will be an easy to administer pre-filled syringe (kept at <40°) and be promoted to ENT specialists in the major US metro areas.
AM-111 is on-track with Ph 3 HEALOS trial and may not be able to complete the ASSENT trial (exp init by YE16) w/o partnership and/or addt'l financing.

AM-101 update: EARS presented details surrounding AM-101 in acute tinnitus and both TACTT2/3 pivotal trials.
(TACTT2, N. America: n=330, onset<3mths and TACTT3, EU, Stratum A: n=300 tinnitus onset < 3mths, Stratum B: n=330 tinnitus onset of 3-6mths). Recall, TACTT2 has a SPA w/ the FDA and is on-track to rd-out top-line results from the co-primary endpts of improvement
on tinnitus loudness question (TLQ) and tinnitus functional index (TFI).

Mgmt indicated that they will have a pre-NDA meeting with the FDA (exp Oct-Nov) and upon positive results, discussions will include if the results from TACTT2 are sufficient, based upon
the current unmet clinical need. In the worst case, they will submit TACTT2 & 3 results together to both FDA and EMA (exp ~1H17). Further, mgmt. admitted that the product will be manufactured with clinicians in mind and be a pre-filled syringe (kit of 3) required
to be refrigerated (life: ~3yrs).

Thoughtfully, the company reminded investors that a KOL event led by Dr. Staecker, the TACTT2 trial principle investigator, will be held on Jun-14-2016 and focusing on the tinnitus clinical dvlpmt program and market opportunity.

On the commercial side, EARS proposed plans to target the urban areas of the US w/ a sales force of 40-60 reps spread throughout the major US cities. Further, since the company does not expect '101 to be a hospital formulary they would plan to target private (ENT) clinics.

On the financial front, mgmt. has indicated that financing for '101 is secured and plans to reach all milestones in 2016, w/ expected cash runway until Fall '17. Although, mgmt. appears confident to achieve '101 milestones they are actively seeking a partnership for their assets.

Notably, mgmt. seemed most interested in partnering with regional companies (i.e Japan, China, and HK) to capture the market opportunity in Asia. We currently model a 65% prob of success for '101 and WW pk adjst sales $324M in 2026. AM-111 update: AM-111 in acute inner hearing loss was mentioned today with details surrounding the clinical development and financing involved moving forward in development.

The company admitted that while HEALOS (EU/Asia, no corticosteroids req'd, n=~255) is exp to read out Ph 3 data, with '101 milestones met; the ASSENT trial may not be brought to completion (N. America, corticosteroids incl., n= ~300) (exp init YE16) w/o a partnership and/or additional financing. We currently model a 35% prob of success for '111 and pk prob adjst sales of $32M in 2028.
 
@Bobby B
I am wondering how this am101 will be approved by FDA ,reading this thread I see almost all participnts don't report any improvement from this trial except two or three membres may be it's a placebo effect.:meh:
 
@Bobby B
I am wondering how this am101 will be approved by FDA ,reading this thread I see almost all participnts don't report any improvement from this trial except two or three membres may be it's a placebo effect.:meh:

It's probably like the AUT trial, where a couple of members here had great results, but the trial was cancelled due to lack of efficacy. TT isn't a proper sample set it appears.
 
@Bobby B
I am wondering how this am101 will be approved by FDA ,reading this thread I see almost all participnts don't report any improvement from this trial except two or three membres may be it's a placebo effect.:meh:
My guess is It will work well only very early on like the first week after trauma
Most people here had it months later - too late
 
It's not a cure this time but next time anyone has an acoustic trauma they have to hurry up get this ASAP and have a chance - I really hope it's going to get approved
 
@Bobby B
I am wondering how this am101 will be approved by FDA ,reading this thread I see almost all participnts don't report any improvement from this trial except two or three membres may be it's a placebo effect.:meh:

Well this thread is a small sample size, and most of the people here didn't get the real drug till several months after onset.
Even though I haven't quite had the improvement I had hoped for, I hope Auris is successful. It would mean more money for research into other tinnitus treatments.
 
It's probably like the AUT trial, where a couple of members here had great results, but the trial was cancelled due to lack of efficacy. TT isn't a proper sample set it appears.
here we had 4 participants in AUT trial ,two had an improvenment two others no ,so the rate of succes is 50% .despite this result the trial is canceld. Am 101 many participants only two or three had an improvement the trial is not canceld I am confused here :meh:
 
Well this thread is a small sample size, and most of the people here didn't get the real drug till several months after onset.
Even though I haven't quite had the improvement I had hoped for, I hope Auris is successful. It would mean more money for research into other tinnitus treatments.
I hope that it will not work because if it will work realy ,we as a chronic suffers will be ignored and they will never make efforts to find a cure for us .I hope that there will be a treatement for all tinnitus suffers.
 
I hope that it will not work because if it will work realy ,we as a chronic suffers will be ignored and they will never make efforts to find a cure for us .I hope that there will be a treatement for all tinnitus suffers.

If it works it will help chronic to bring down the permanent spikes...it did for a guy in this forum.
 
Does any have any information if trials are still in the process somewhere in the world?

I have emailed medpace but they have not replied to my email so I've sent another one. Also does anyone know if you have to be a citizen of that country to participate in the trial?
 
Does any have any information if trials are still in the process somewhere in the world?
Dude... if you check just one page back, you will find the following information:

upload_2016-6-16_12-5-14.png
 
3 weeks and 5 days after injection of am 101 or placebo .... my tinnitus is like constantly worse and didn't yet go back to baseline before the injection ((
 

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