Investors appear to be betting the Auris Medical Holdings AG (NASDAQ:EARS) will have some positive developments to report next week about its hearing loss program.
The Switzerland-based company provided very little insight about what could be coming, only saying that they will provide an update on its AM-111 program on January 4, 2018, with the announcement to be followed by a live conference call at 8:00 AM EST.
The call will feature Dr. Hinrich Staecker, Professor of Otolaryngology at the University of Kansas Medical Center.
Auris Medical is advancing AM-111 for the treatment of acute inner ear (sensorineural) hearing loss (ASNHL). The active ingredient is brimapitide, which is formulated as a gel and injected into the middle ear where it subsequently diffuses through the round window membrane into the cochlea.
Auris is developing AM-111 under Orphan Drug designations from both the U.S. FDA and European Medicines Agency. There are currently no approved drugs for ASNHL.
AM-111 is is in Phase 3 development that began in June 2016 and is slated for completion early in 2018, according to the clinicaltrials.gov website. Dr. Staecker is the principal investigator for the Phase 3 trial coined "ASSENT" (Acute Sudden Sensorineural Hearing Loss Treatment).
Investors seem to be banking on Auris and Dr. Staecker having some good data from the trial, as shares are up 21.3% to 56.4 cents as of about 1:00 p.m. EST after printing as high at 66 cents in morning trading.
Shares fell off a cliff late in November from near a dollar when the company said its other Phase 3 study (dubbed "HEALOS") of AM-111 for sudden deafness failed to meet its primary endpoint of a statistically significant improvement in hearing compared to placebo in either of two treatment groups.
On a positive note, a post-hoc analysis showed certain patients with profound acute hearing loss did realize a statistically significant improvement, which is serving as the basis for ongoing discussions about potential commercialization of the AM-111 for a specific indication.
