Auris Medical Holding Ltd (NASDAQ: EARS), a clinical-stage company dedicated to developing therapeutics that address important unmet medical needs in neurotology and central nervous system disorders, announced the completion of patient enrollment into Part A of its Phase 2 “TRAVERS” trial with intranasal betahistine in vertigo (AM-125). The Company expects to release interim results from TRAVERS and commence Part B of the trial in the coming weeks.
Thomas Meyer, Auris Medical’s Founder, Chairman, and CEO said, “Thanks to a quicker than expected recovery of study activities following the COVID-19 outbreak, we are very pleased to announce the completion of enrollment into Part A of TRAVERS. We look forward to analyzing the interim results and anticipate further improvement in recruitment rates as we will begin Part B of TRAVERS.”
In Part A of the TRAVERS trial, three ascending doses of AM-125 or placebo, administered three times daily over a total of four weeks, will be tested in a total of 30 patients. The primary endpoint will be the improvement of vestibular function from baseline to Day 14. This is assessed by measuring for how long patients are able to maintain their balance with eyes closed—once while standing on foam, and once while doing the tandem Romberg test, which requires the two feet to be aligned one after the other. The results from the interim analysis will inform the selection of two doses for further testing against placebo in an estimated 72 patients in Part B of the trial. While the interim analysis will be carried out and prior to starting Part B, open label testing of oral betahistine for reference purposes will be completed (n=16).
Source: Auris Medical