A Treatment for Sudden Deafness Fails in Phase 3 Trial

Auris Medical is developing what could be the principal treatments for inner ear disorders, for example, hearing loss, tinnitus, and vertigo. The company suffered a setback. Its lead candidate, AM-111, failed to demonstrate a statistical change in hearing following 28 days when compared with a placebo in patients experiencing severe or profound sudden deafness.

Auris has shown that the treatment showed a measurable improvement in a subgroup of patients with profound sudden deafness those with the largest loss of hearing, more than 80 decibels (dB). In any case, this was found in a post-hoc examination and was valid for the least of two doses tested.

HEALOS is a randomized, double-blind, placebo-controlled examination assessing the safety, efficacy, and tolerability of AM-111. The trial was conducted in a few European and Asian countries and enrolled 256 patients suffering from severe to profound sudden deafness within 72 hours from beginning. Patients were randomized in a 1:1:1 proportion to get a single dose of AM-111 0.4 mg/mL, AM-111 0.8 mg/mL, or placebo, administered into the middle ear.

For patients in the AM-111 0.4 mg/mL group compared with 33.4 dB for the placebo group (P = 0.226), the hearing change at the three worst affected contiguous test frequencies at day 28 was 38.4 dB.For patients in the AM-111 0.8 mg/mL group the change was 36.6 dB (P = 0.448).

At day 28 of 42.7 dB in the AM-111 0.4 mg/mL group versus 26.8 dB in the placebo treatment group, post-hoc study in the subpopulation of patients with profound hearing loss (n = 98) demonstrated an improvement, which was statistically significant (P = 0.0176). The improvement was 37.3 dB in the AM-111 0.8 mg/mL gathering (P = 0.126).

AM-111 was very much tolerated, and the essential safety endpoint was met. There was no significant contrast in the event of clinically relevant hearing deterioration between both of the actively treated groups and the placebo group at day 28.

In view of the findings from the HEALOS trial, Auris has concluded that the very similar design of the as of now progressing ASSENT trial is never again adequate for testing AM-111. The ASSENT trial will be ended early.


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