On January 4th 2018, Auris Medical Holding AG (ticker symbol: EARS) provided an update on AM-111 for the treatment of sudden sensorineural hearing loss. The approximately 50-minute presentation and Q&A-session were preceded by a press release by Auris Medical on the same day, and combined, the two updates contributed further knowledge on post-hoc analysis subpopulation efficacy (despite AM-111 missing the overall primary efficacy endpoint in the HEALOS trial as announced in November 2017).
Highlights of the January 4th presentation included:
- A presentation by Dr. Hinrich Staecker describing the unmet medical needs of patients having suffered sudden sensorineural hearing loss. There are currently no FDA-approved drugs for the condition; corticosteroids are typically administered, but their efficacy is debated. Profound acute sudden hearing loss has the worst chance of recovery making it more likely to become a chronic condition.
- Although the overall HEALOS study failed to meet its primary endpoint in terms of hearing threshold recovery, a subpopulation – those with profound hearing loss – was found to benefit in a statistically- and clinically-meaningful way. The presentation explained that without a sufficiently severe auditory insult, there is no clear drug target due to lack of JNK activation.
- Hearing recovery in the placebo group was better than expected thereby reducing the chance of a statistically significant result in the HEALOS study.
- Despite the 2nd phase-III study (“ASSENT”) having been discontinued upon learning the lack of overall efficacy in the HEALOS study, Auris Medical now intends to try to bring AM-111 to market for the indication of “profound acute sensorineural hearing loss” as a result of the additional post-hoc analyses. Based on available studies, those in the profound-category represent about 25-30% of patients treated for sudden deafness.
- AM-111 has the potential to become the first treatment for acute inner ear hearing loss.
- A discussion of the regulatory pathways available to bring AM-111 to market – including the possibility of a conditional approval in the EU.
- Further updates will be made available in 2018.
A full transcript is available at the Cochlear Info Repository (available to journalists, researchers, clinicians, investors, and online community managers).