Auris Medical initiates Phase III trial for sudden deafness treatment
Auris Medical (NASDAQ: EARS) has announced that it has initiated enrolment for a new Phase III trial that will evaluate their drug, AM-111, in patients with idiopathic sudden sensorineural hearing loss, which is also called sudden deafness.
The ASSENT trial will be the second of two pivotal trials in Auris’s clinical development program for AM-111. The ongoing HEALOS trial was initiated in November 2015. In Phase II trials, patients with severe to profound hearing loss showed a statistically significant improvement in hearing threshold, speech discrimination and a higher rate of complete tinnitus remission with AM-111 compared to placebo.
AM-111 contains the synthetic peptide D-JNKI-1 and works by blocking the JNK stress kinase which, when activated, plays a key role in causing acute inner ear hearing loss. It has been granted orphan drug designation in both the US and the EU.
In this latest trial, 300 patients are set to be recruited in the US, Canada and South Korea. The primary efficacy endpoint for the trial is the improvement of pure tone hearing thresholds from baseline to day 91.
Thomas Meyer, CEO at Auris Medical, says: “For many patients, sudden deafness is a very frightening experience and may result in chronic hearing loss and tinnitus as well as a significantly reduced health-related quality of life. The start of ASSENT is yet another important milestone on our way toward the development of AM-111 as the first specific therapeutic for acute inner ear hearing loss.”