Auris Medical Snags CHMP Approval to Launch Another Phase III Trial for AM-111
Shares of Switzerland-based Auris Medical Holding AG shot up nearly 10 percent Monday after the company announced it received clearance to begin a new Phase III trial for AM-111, the company’s investigational treatment for acute inner ear hearing loss.
Auris said it requested Scientific Advice (protocol assistance) from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) as it looks to advance AM-111 in a second Phase III trial. The company made the request following a November 2017 report that AM-111 did not meet primary endpoints in its HEALOS study. While the primary endpoint of that trial was not met, the company did attempt to put a positive spin on things by pointing to efficacy in a subpopulation. BioSpace reported last year that the company noted “statistically and clinically significant treatment effects in the profound hearing loss subpopulation.” On Monday the company said a post-hoc analysis showed AM-111 delivered a clinically meaningful and nominally significant improvement in hearing for those who took a lower dose, in comparison to placebo. Auris said those patients were initially completely deaf or almost deaf in the affected ear and “normally would have faced a particularly poor prognosis for hearing recovery.”
The EMA reviewed Auris’ proposed concept for a single pivotal trial, which will build on the design and outcome of the HEALOS trial. Auris said the EMA endorsed the trial design and protocols. Additionally, the EMA did provide “important guidance on the regulatory path forward” for AM-111, as well as the maintenance of AM-111's orphan drug designation. Last year AM-11 also received Fast Track status from the U.S. Food and Drug Administration.
AM-111 has the active ingredient brimapitide and is being developed in a biocompatible gel formulation for the treatment of acute sensorineural hearing loss with a single-dose administration into the middle ear. AM-111 is designed to inhibit the JNK stress kinase. By blocking JNK, AM-111 protects stress-injured cochlear cells and helps to prevent or reduce chronic hearing loss.
Thomas Meyer, Auris Medical’s chief executive officer, said the company appreciates the EMA’s “thorough and very helpful comments and guidance for our AM-111.”
“We are very pleased to see the design for the single pivotal phase 3 trial validated and to have the path towards market approval in Europe mapped out. We now look forward to discussing the path forward also with the FDA, for which we intend to request a Type C meeting shortly,” Meyer said in a statement.
Auris said Monday that it will provide an update on its AM-111 plans as part of a general strategy update on May 15, which will be released alongside its first quarter financial reports.
The news was certainly a relief for the company and its investors following a blow the company received earlier this year when its late-stage tinnitus drug AM-101 failed to meet endpoints in a Phase III trial for the second time. In March the company announced AM-101 (Keyzilen) failed to meet its primary efficacy endpoint of a statistically significant improvement in the Tinnitus Functional Score after 84 days of treatment. That was the second time AM-101 failed at the late stage. In 2016 the therapy failed to show statistically significant changes in tinnitus loudness and tinnitus burden compared to placebo.