Member- May 8, 2012
- 1,601
- Tinnitus Since
- 04/15/2012 or earlier?
- Cause of Tinnitus
- Most likely hearing loss
Am 101
Auris Medical presents the key results from its phase IIb study with AM-101, a novel intratympanic (i.t.) treatment for acute inner ear tinnitus, at the recent 6th International TRI Tinnitus Conference in Bruges, Belgium
The study demonstrated that the treatment was well tolerated and safe and showed a statistically significant reduction in various tinnitus measures as compared to placebo.
The outcomes were presented by Prof. Paul van de Heyning, head of the Department of Otorhinolaryngology at Antwerp University Hospital and one of the coordinating investigators of the study.
The double-blind, randomized, placebo-controlled, parallel-dose phase IIb study with AM-101 was conducted in Germany, Belgium, Poland and the Netherlands, involving almost 30 sites. A total of 248 patients suffering from persistent acute inner ear tinnitus were randomized to receive three i.t. injections of either AM-101 at 0.27 or 0.81 mg/ml or placebo over three consecutive days. Their tinnitus had to be triggered by acute acoustic trauma, sudden deafness (idiopathic sudden sensorineural hearing loss, ISSNHL) or otitis media and to be no older than three months. The clinical trial evaluated the safety and local tolerance of AM-101 and various efficacy outcomes. Study participants were monitored over 90 days.
The safety assessment of AM-101 in the phase IIb study showed no drug-related impact on hearing function. Anticipated adverse events related to the procedure of i.t. injection were of transient nature and occurred in moderate to low numbers. In terms of efficacy, the study demonstrated a dose-dependent improvement in various measures of the tinnitus symptom and its impact. Patients suffering from acute tinnitus with established cochlear origin (i.e. after noise trauma or otitis media) who received AM-101 at 0.81 mg/ml showed a statistically significant improvement (p <0.05 or <0.01) in tinnitus loudness, annoyance as well as tinnitus-related sleep difficulties and activity and participation limitations (TBF-12 questionnaire). In most cases the treatment effect started to appear within a few days from administration and continued to increase over the follow-up period. At Day 90, average reductions from baseline levels exceeded 50 per cent for subjective loudness, annoyance and sleep difficulties and close to 50 per cent for the TBF-12 score. Effects were somewhat less pronounced in patients with bilateral rather than unilateral tinnitus since only one ear was treated in the study as a precautionary safety measure. Efficacy outcomes with patients suffering from tinnitus related to ISSNHL were not conclusive for that subgroup overall, owing to an unexpectedly large rate of spontaneous recovery.
"The outcomes from the phase IIb study established proof of concept for AM-101's efficacy in the treatment of acute inner ear tinnitus," stated Prof. van de Heyning. "The robust and clinically meaningful improvements observed both for tinnitus loudness and patient-perceived tinnitus impact, as well as the good acceptance and tolerance of the treatment by patients, appear very promising." Based on the positive outcomes from the phase IIb study, Auris Medical is moving ahead with the clinical development of AM-101, and is currently in discussion with regulatory agencies on the design for the planned phase III studies.
"The phase IIb trial confirmed the importance of a targeted approach to tinnitus treatment, given the many different aspects of this bothersome symptom," stated Thomas Meyer, Auris Medical's founder and managing director. He added: "The trial provided us with a wealth of data and insights into AM-101's therapeutic benefits and safety, which together with the outcomes from the currently ongoing TACTT1 study and the input from regulatory agencies will be essential for the appropriate design of the confirmatory phase III studies and the path towards marketing approval."
Unfortunately, this is only in first 3 months of inception and only certain types of tinnitus, but a positive step for research nonetheless.
Auris Medical presents the key results from its phase IIb study with AM-101, a novel intratympanic (i.t.) treatment for acute inner ear tinnitus, at the recent 6th International TRI Tinnitus Conference in Bruges, Belgium
The study demonstrated that the treatment was well tolerated and safe and showed a statistically significant reduction in various tinnitus measures as compared to placebo.
The outcomes were presented by Prof. Paul van de Heyning, head of the Department of Otorhinolaryngology at Antwerp University Hospital and one of the coordinating investigators of the study.
The double-blind, randomized, placebo-controlled, parallel-dose phase IIb study with AM-101 was conducted in Germany, Belgium, Poland and the Netherlands, involving almost 30 sites. A total of 248 patients suffering from persistent acute inner ear tinnitus were randomized to receive three i.t. injections of either AM-101 at 0.27 or 0.81 mg/ml or placebo over three consecutive days. Their tinnitus had to be triggered by acute acoustic trauma, sudden deafness (idiopathic sudden sensorineural hearing loss, ISSNHL) or otitis media and to be no older than three months. The clinical trial evaluated the safety and local tolerance of AM-101 and various efficacy outcomes. Study participants were monitored over 90 days.
The safety assessment of AM-101 in the phase IIb study showed no drug-related impact on hearing function. Anticipated adverse events related to the procedure of i.t. injection were of transient nature and occurred in moderate to low numbers. In terms of efficacy, the study demonstrated a dose-dependent improvement in various measures of the tinnitus symptom and its impact. Patients suffering from acute tinnitus with established cochlear origin (i.e. after noise trauma or otitis media) who received AM-101 at 0.81 mg/ml showed a statistically significant improvement (p <0.05 or <0.01) in tinnitus loudness, annoyance as well as tinnitus-related sleep difficulties and activity and participation limitations (TBF-12 questionnaire). In most cases the treatment effect started to appear within a few days from administration and continued to increase over the follow-up period. At Day 90, average reductions from baseline levels exceeded 50 per cent for subjective loudness, annoyance and sleep difficulties and close to 50 per cent for the TBF-12 score. Effects were somewhat less pronounced in patients with bilateral rather than unilateral tinnitus since only one ear was treated in the study as a precautionary safety measure. Efficacy outcomes with patients suffering from tinnitus related to ISSNHL were not conclusive for that subgroup overall, owing to an unexpectedly large rate of spontaneous recovery.
"The outcomes from the phase IIb study established proof of concept for AM-101's efficacy in the treatment of acute inner ear tinnitus," stated Prof. van de Heyning. "The robust and clinically meaningful improvements observed both for tinnitus loudness and patient-perceived tinnitus impact, as well as the good acceptance and tolerance of the treatment by patients, appear very promising." Based on the positive outcomes from the phase IIb study, Auris Medical is moving ahead with the clinical development of AM-101, and is currently in discussion with regulatory agencies on the design for the planned phase III studies.
"The phase IIb trial confirmed the importance of a targeted approach to tinnitus treatment, given the many different aspects of this bothersome symptom," stated Thomas Meyer, Auris Medical's founder and managing director. He added: "The trial provided us with a wealth of data and insights into AM-101's therapeutic benefits and safety, which together with the outcomes from the currently ongoing TACTT1 study and the input from regulatory agencies will be essential for the appropriate design of the confirmatory phase III studies and the path towards marketing approval."
Unfortunately, this is only in first 3 months of inception and only certain types of tinnitus, but a positive step for research nonetheless.
