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Auris Medical reported the results of the first clinical trial with AM-101, its investigational drug for the treatment of inner ear tinnitus
Basel, Switzerland | August 21, 2008 | Auris Medical reported the results of the first clinical trial with AM-101, its investigational drug for the treatment of inner ear tinnitus. The double blind, randomised clinical trial with placebo control involved four study sites in Germany and had the evaluation of AM-101’s safety as primary objective. As a secondary objective, the potential efficacy of AM-101 was evaluated. The study results show that intratympanically injected AM-101 was well tolerated by study participants, and provided first indications of therapeutic efficacy.
The first clinical evaluation of AM-101, an investigational medicinal product under development by Auris Medical for the treatment of inner ear tinnitus, was conducted from March 2007 to March 2008 in a phase I/II study in Germany. A total of 24 patients suffering from persisting moderate to severe tinnitus following acute noise trauma or sudden deafness were enrolled at 4 study centres (3 clinics of the German Bundeswehr and 1 private ear, nose and throat practice). Their tinnitus had been refractory to a first-line corticoid treatment prior to study inclusion, and was not older than 3 months (i.e. still at an acute stage).
Study participants were randomized to receive either AM-101 or placebo in a single dose intratympanic injection, whereby a total of 4 dose concentrations were tested under a dose escalation scheme. Follow-up visits were performed 7, 30 and 60 days after treatment administration. The primary objective of the study was to evaluate the safety of AM-101 delivered by intratympanic injection. Secondary objectives were a preliminary evaluation of the potential therapeutic benefit of AM-101 in the treatment of acute inner ear tinnitus as well as the determination of the systemic exposure from local drug administration. The study’s lead investigator was Professor Heinz Maier, Head of the Otorhinolaryngology and Head and Neck Surgery Department of the Bundeswehr clinic of Ulm (Germany).
At baseline, i.e. before administration of AM-101, study participants on average had had tinnitus for 62 days. In 19 cases, tinnitus had been provoked by acute acoustic trauma, in 5 cases it had been related to sudden deafness. A slight majority of patients suffered from bilateral tinnitus (13 out 24), in which case only the worse affected ear was treated. The average audiogram was downward sloping with a maximum hearing loss at 6 kHz.
Overall, AM-101 was well tolerated by study participants, irrespective of the administered dose. Adverse events occurred in only few patients and were either unrelated or considered unlikely related to the pharmaceutical treatment. AM-101 and its primary metabolite could be found in plasma samples obtained in the first hours following treatment in traces only, which confirmed the favourable safety profile of intratympanic injection. This minimally invasive procedure allows for a highly site specific treatment with low doses and only minimal systemic exposure.
In terms of efficacy, the clinical trial provided first indications for the potential efficacy of AM-101 in the treatment of inner ear tinnitus. The clinical data suggest that AM-101 has a positive effect on the perceived loudness of tinnitus as well as on its maskability; in addition, a positive trend was observed in the overall tinnitus handicap as measured by the TBF-12 questionnaire. Further details of the clinical trial and its outcomes shall be published later in a scientific journal.
Thomas Meyer, Auris Medical’s founder and Managing Director, commented: “We are very pleased with the positive results from this first clinical evaluation of AM-101. The trial not only confirmed the presumed good safety profile following local application, but also provided encouraging early indications of potential efficacy.” He added that the successful conclusion of the study represented an important milestone for Auris Medical and the development of a treatment for inner ear tinnitus, an area of great unmet medical need. In a next step, Auris Medical is planning to test AM-101’s efficacy in a phase IIb clinical trial with a substantially larger number of participants.
SOURCE: Auris Medical |
