Additional clinical results from HEALOS trial of AM-111 for the treatment of acute inner ear hearing loss.- Auris Medical.

Auris Medical Holding AG announced further clinical results from the HEALOS Phase III clinical trial that investigated Auris Medical Holding AG announced further clinical results from the HEALOS Phase III clinical trial that investigated AM-111 in the treatment of acute inner ear hearing loss and provided an update on the AM-111 development program. While the HEALOS trial had not met the primary efficacy endpoint in the overall study population, post-hoc analyses of top-line data revealed a clinically and statistically significant hearing improvement with AM-111 from baseline to Day 28 in the subpopulation of patients with profound hearing loss (n=98). The AM-111 0.4 mg/mL treatment group showed a mean improvement of 42.7 dB vs. 26.8 dB in the placebo group (p=0.0176). The improvement was 37.3 dB in the AM-111 0.8 mg/mL group (p=0.126). AM-111 was well tolerated and the primary safety endpoint was met. AM-111 treated patients had a lower incidence of no hearing improvement Further analyses on the basis of the full data set provide additional confirmation of and support for AM-111's otoprotective effects in the profound acute hearing loss subpopulation. Patients treated with AM-111 0.4 mg/mL showed a statistically significantly lower incidence of no hearing improvement compared to placebo by Day 91 (11.4 vs. 38.2%, risk ratio 0.30, p=0.012). They also had a lower incidence of no marked hearing improvement (28.6 vs. 50.0%, risk ratio 0.57, p=0.087). In addition, the significant improvement in pure tone hearing in the AM-111 0.4 mg/mL group was coupled with superior improvement in speech discrimination as the score of correctly recognized words improved by 49.2 percentage points to Day 91 compared to 30.4 percentage points in the placebo group (p=0.062).

The results from the profound acute hearing loss subgroup in HEALOS are broadly in line with those observed in the same subpopulation in the prior Phase II clinical trial with AM-111 (n=12 for AM-111 0.4 mg/mL and n=10 for placebo). Pooling the data from the two trials shows that hearing improved in the active group by 13.9 dB and 14.5 dB over the placebo group at Days 28 and 91, which is clinically and statistically significant (p=0.017 and 0.020, respectively). The relative risk ratio for no improvement at Day 91 was statistically significant at 0.39 (incidence 14.9 vs. 38.6%, p=0.016).

The Company expects data from a further 31 patients who enrolled in the ASSENT trial with profound acute hearing loss towards the end of the first quarter of 2018. ASSENT is being terminated early in order to avoid the need for substantial protocol changes and interruptions of enrollment pending feedback from health authorities on the regulatory pathway. The Company plans to discuss the accumulated safety and efficacy data and the regulatory pathway with the FDA and EMA in the second quarter of 2018. The data will also be submitted for peer review publication and presentation at a medical meeting in 2018.