The assets acquired by Auris Medical, including preclinical and clinical data, as well as intellectual property rights, have been fully transferred to Auris Medical according to the announcement. Together the assets form the foundation for further development of AM-125, an intranasal formulation of betahistine, for the treatment of Meniere’s disease and other vestibular disorders.
Meniere’s disease has been estimated to affect approximately 600,000 people in the US, and as many as 5 million worldwide. The debilitating condition — with symptoms of vertigo, fluctuating hearing loss and tinnitus — is most often managed, with varying degrees of success, through dietary changes, diuretics and steroids.
There are currently no FDA-approved drugs to treat Meniere’s disease.
Meniere’s Disease Drug Treatment
In addition to Auris Medical’s asset acquisition from Otifex, the company also obtained (from an undisclosed party) the rights to certain proprietary preclinical and clinical data that will further support the development of AM-125 and assist with future regulatory filings.
“We are pleased to have efficiently assembled a package of relevant data to support the development of intranasal betahistine, a program with the potential to deliver significant clinical benefits to patients with vestibular disorders. Next, we plan to discuss the development strategy with U.S. and European regulatory agencies, with the goal of initiating the second Phase 1 trial of AM-125 in the fourth quarter of this year. We are targeting a U.S. investigational new drug (IND) submission in the first quarter of 2018 and would expect to proceed to a Phase 2 proof-of-concept trial following regulatory clearance.” –Thomas Meyer, Auris Medical Chairman and CEO
Based on the company’s announcement, previous Phase 1 trials of intranasal betahistine demonstrated good tolerance and significantly higher blood plasma concentrations when compared to data reported with oral betahistine. Further, a 14-day study in beagle dogs demonstrated that intranasal delivery was well tolerated with repeated dosing. The second
A second Phase 1 clinical trial of AM-125, scheduled for later this year, is planned to further examine single- and multiple-ascending doses in healthy subjects. The study outcomes will inform dose selection and regimen for a subsequent Phase 2 proof-of-concept trial of AM-125.