Auris Medical Holding AG (NASDAQ:EARS) Q2 2020 Earnings Conference Call - Final Transcript
Sep 17, 2020 • 08:30 am ET
drug-free nasal spray for protection against airborne pathogens and allergens. This spray has the potential to protect against a wide variety of pathogens and allergens. And we are pleased to report that we have already seen positive indications in SARS-CoV-2 in vitro assay. We'll be conducting more studies throughout the rest of the year.
Finally, from an operational and financial standpoint, we continue to reduce our operating expenditures and cash burn rate. I'm pleased to say that we managed to align our spending with a temporarily reduced activity levels in our key clinical trial during the main, COVID-19 lockdown phase in Europe. On the other hand, we used that lockdown to come up with some fresh ideas on how to self protect against airborne pathogens and allergens, leading to the establishment of a new subsidiary Altamira Medica, which is dedicated solely to the development of AM-301. We are pleased to have secured a convertible loan in order to kick-off AM-301's development.
Lastly, we recently initiated a strategic review to explore, review and evaluate a broad range of potential strategic alternatives for the company, with the aim of unlocking the potential of our various assets. I will discuss this in a bit more detail following the program updates.
Moving to Slide 3, I will now provide an update on each of our betahistine development projects.
On to Slide 4, I will start the program update with AM-125 intranasal betahistine for the treatment of acute vertigo. As a reminder, oral betahistine is the standard of care treatment for vertigo in many countries around the world. But its therapeutic potential is limited due to its low bioavailability. AM-125 is currently being assessed in our TRAVERS Phase 2 trial, which is conducted in several European countries and hopefully soon also in Canada and Australia.
The trial is to recruit 118 patients suffering from acute vertigo following certain types of neurosurgery. In the trial, we treat patients 3 times daily for four weeks, with AM-125 or placebo. The objective is to allow patients to regain control of their balance, sooner and to improve their quality of life. The primary endpoints were defined as improvement in how long patients maintain balance in the Tandem Romberg and Standing on Foam tests from baseline to 14 days post surgery. We just finished Part A of the trial, which serve for those finding and are currently enrolling patients for open label treatment with oral betahistine to generate additional reference data. The trial will conclude with Part B.
On to Slide 5. Part A of the trial demonstrated a dose-dependent improvement in balance, as well as good safety and tolerability of ascending doses of AM-125. At the highest dose of 20 milligram AM-125 treated patients improved their performance on the Tandem Romberg and the Standing on Foam balance tests. You see some pictures of those tests on the slide. On average 1.9 times to 2.4 times more than placebo-treated patients. So that's 6 versus 3.1 seconds and 10.5 versus 4.3