Auris Medical said that the first part of the Phase 2 TRAVERS study of its AM-125 intranasal betahistine for the treatment of vertigo has demonstrated a dose dependent improvement in balance up to 2.4 times greater than placebo at the highest dose. The company had announced the initiation of the TRAVERS trial in July 2019.
The 4-week trial evaluated 1, 10, or 20 mg doses of AM-125 versus placebo three times daily in 33 patients who had vertigo after neurosurgery. All dose groups of AM-125 demonstrated statistically significant improvement in balance compared to baseline. Patient-reported and clinician-reported improvements were similar, the company said. The second part of the study will evaluate the 10 and 20 mg doses, with the standing on foam test as the primary endpoint.
Auris Medical Chairman and CEO Thomas Meyer commented, “We are very excited and encouraged by the good safety and tolerability as well as the strong and consistent signals of AM-125’s clinical efficacy observed in this first part of the TRAVERS trial. For patients suffering from vertigo, regaining balance as quickly as possible is of utmost importance. Unlike other vertigo drugs that suppress the vestibular function to treat just short-term symptoms such as nausea, AM-125 acts as a vestibular stimulant to enhance and accelerate vestibular compensation and help patients to ‘get back on their feet’. There is a strong medical need for a novel drug in this area, with e.g. 35.4% of the US population aged 40 years and older suffering from vestibular dysfunction (i.e. failing the standing on foam test). We look forward to advancing the AM-125 program further in order to bring this innovative nasal spray to patients.”
Read the Auris Medical press release.
