Auris announced today that they initiated the patient enrollment for ASSENT Phase 3 Clinical Trial of their candidate drug AM-11. The drug will be used to treat patients with sudden deafness or also known as Idiopathic Sudden Sensorineural Hearing Loss or ISSNHL. Auris Medical Holding AG is a clinical-stage company that develops therapeutic medicines used for the treatment of unmet needs in otolaryngology.
Thomas Meyer, Chief Executive Officer, Chairman, and Founder of Auris Medical said that the enrollment of the first patient in ASSENT Trial signals that the pivotal program for AM-111 has finally begun. Meyer added that, for many patients, sudden deafness can be a frightening and traumatic experience. This condition may lead to tinnitus and chronic hearing loss that will significantly affect the quality of life of the patient.
The ASSENT Clinical Trial is an important milestone for the development of AM-111 as the first therapeutic and specific drug to treat acute inner ear hearing loss.
ASSENT trial is a placebo-controlled, randomized and double-blind study used to evaluate the tolerability, safety and efficacy of intratympanic administration and single dose treatment of AM-111.
The clinical trial will be conducted in South Korea, U.S. and Canada. The company plans to enroll over 300 patients suffering from severe to profound forms of ISSNHL. Patients who will be included are those who had the disorder at 3 days after the onset of the condition. The study participants will be randomized to receive varying doses of AM-111 or the placebo.
Patients may be given 0.4 mg/ml or 0.8 mg/ml or the placebo in 1:1:1 ratio. The oral corticosteroid will serve as background therapy. The primary end point of the study in terms of efficacy is to be able to measure an improvement in pure tone hearing thresholds. The data will be compared from the baseline up to Day 91.
Auris initiated two pivotal trials for the Phase 3 clinical development of AM-111. The first trial is called HEALOS, which is currently being conducted in several Asian and European countries. The study was started last November 2015 with around 255 patients while, the second trial is the ASSENT study.
The Phase 2 of the clinical trial program patients having severe to profound hearing loss showed statistically significant improvement in terms of hearing threshold and speech discrimination. They also have a higher rate of tinnitus remission compared with the placebo. Patients were given a dose of 0.4 mg/ml.
What is an Acute Inner Ear Hearing Loss?
Acute Hearing Loss is caused by an injury to cochlea. It results from having too much exposure on infectious agents like bacteria and viruses, noise, inflammation and or vascular compromise. These agents may damage the neurons and inner ear hair cells which lead to acute hearing loss. Good thing, the body has intrinsic repair mechanisms and other cellular defenses that allow recovery after few days or weeks of the insult.
But not all parts of the inner ear will be recovered; some may have permanent damage that may cause irreversible hearing loss. This condition may be accompanied by other related disorders like dizziness or tinnitus that may develop into a permanent loss of hearing and may have other chronic and debilitating consequences.
The Debilitating Impact of Hearing Loss
Hearing loss has a serious impact on the personal and professional lives of the patient. Acute or chronic hearing loss may reduce alertness of the patient. It may increase their risk for personal safety and it may hamper their ability to learn and get familiar with new tasks. Hearing loss may also reduce their earning potential and job performance.
As of this moment, there is no treatment for acute inner hearing loss with a proven efficacy. Thus, AM-111 can be a first-line treatment if granted an approval.