Auris Medical reports positive results from phase IIb trial

Preliminary results from the phase IIb study show that the local treatment with AM-111 was well tolerated. In addition, the study demonstrated a substantial improvement in hearing threshold and speech discrimination score. In subjects with severe to profound hearing loss who were treated with AM-111 0.4 mg/mL, the primary study endpoint, absolute hearing improvement in the 3 most affected contiguous test frequencies from baseline to Day 7, was met (p < 0.02, compared with placebo). The differences in hearing and speech discrimination recovery between treatment groups appeared as early as on Day 3 and were clinically relevant.
 
“The cell penetrating peptide AM-111 represents a novel approach to treating ASNHL“, stated Professor Markus Suckfüll, Munich (Germany), coordinating investigator of the study. “The clear and clinically meaningful improvements observed with AM-111 in the treatment of severe to profound hearing loss demonstrate that effective otoprotection is feasible, and they appear very promising. The inclusion of a placebo arm to control for the effects of spontaneous recovery lends particular credibility to the results and will provide also a wealth of important new information for future hearing research.”
 
Thomas Meyer, Auris Medical’s founder and Managing Director, commented: “We are very pleased with the positive results from the phase IIb trial with AM-111, which were achieved under challenging clinical conditions. The outcomes are in line with the positive results from preclinical studies conducted in various ASHNL conditions, which had demonstrated the strong otoprotective effects of the peptide.” In a next step, Auris Medical is planning to discuss the phase IIb results and further clinical development with AM-111 with regulatory agencies.
 
The double-blind, randomized, placebo-controlled phase IIb study with AM-111 was conducted in Germany, Poland and the Czech Republic, involving more than 30 sites. A total of 210 patients suffering from acute acoustic trauma or sudden deafness were enrolled within the first 48 hours following the incident. Their hearing loss, measured against a reference value, had to be at least 30 dB at the average of 3 contiguous audiometric test frequencies. Study participants received one single dose of either AM-111 at 0.4 or 2 mg/ml or placebo by way of i.t. injection and were followed for 90 days. In case of insufficient hearing recovery by Day 7, they were given the option of receiving oral prednisolone as a reserve therapy.
 
Auris Medical is a Swiss biotechnology company founded in 2008 developing specific pharmaceutical compounds for the prevention or treatment of inner ear disorders, an area of great unmet medical need. Around the world, many million people are permanently suffering from severe hearing loss and tinnitus. Truly effective and safe treatments for these disorders are still lacking. Auris Medical is currently focusing on the development of treatments for acute inner ear tinnitus (AM-101) and for acute sensorineural hearing loss (AM-111).