Auris Medical has announced the initiation of the Phase 2 TRAVERS trial of its AM-125 intranasal betahistine for the treatment of acute vertigo resulting from removal of a vestibular schwannoma.
Auris is also developing intranasal betahistine for the treatment of obesity associated with Prader-Willi syndrome and said that it has completed enrollment in a Phase 1b trial of AM-201 for that indication and expects top line results in the third quarter of 2019. The company also said in December 2018 that it intended to license the use of betahistine for depression and attention-deficit/hyperactivity disorder (ADHD).
The Phase 2 trial of AM-125 is expected to enroll a total of 138 patients. The first part of the study will evaluate five ascending doses of AM-125 vs placebo three times a day for four weeks; the second part will continue to evaluate two of those doses.
Auris Medical Founder, Chairman, and CEO Thomas Meyer said, “After securing approvals from the numerous regulatory authorities and ethics committees involved, we are excited to start patient enrollment into the TRAVERS trial. With AM-125, we seek to improve and accelerate vestibular recovery so that patients are back in control of their balance sooner, thus improving their quality of life. Betahistine, the active substance of AM-125, is known to promote vestibular compensation, and we expect intranasal delivery to provide superior efficacy compared to oral administration.”
Read the Auris Medical press release.
