Auris Medical Holding AG (NASDAQ:EARS) Q2 2020 Earnings Conference Call - Final Transcript
Sep 17, 2020 • 08:30 am ET
seconds. So at the beginning at baseline these patients are unable to walk or stand in the vast majority of cases.
In contrast to placebo, the improvement from baseline was statistically significant for AM-125, 20 milligram in the Tandem Romberg test with a p-value of 0.02. And for all active dose groups in the Standing on Foam test with p-values ranging between less than 0.01 and less than 0.05. These positive results were supported by similar improvements in additional efficacy measures, including additional objective as well as clinician and patient reported outcomes.
In terms of next steps, we will be testing the 10 milligram and 20 milligram doses of AM-125 against placebo in 72 patients in Part B of the trial. The improvement in the Standing on Foam test to day 14 will remain the primary efficacy endpoint. The improvement in the more challenging Tandem Romberg test will be assessed as key secondary endpoint at day 45. We are aiming to complete enrollment by the end of Q1 2021 provided that there are no new COVID-19 restrictions on enrollment.
On to Slide 6 and AM-201. A few months before the positive interim results with AM-125, we reported positive outcomes already from our second intranasal betahistine project AM-201. With this project, we are seeking to prevent major side effects of second-generation antipsychotics such as olanzapine, in particular, weight gain and somnolence. These side effects arise from the antagonistic effect of the antipsychotic drugs at histamine 1 receptors in the brain. It's well-known that histamine plays a key role in the brain's regulation of food intake and wakefulness.
The Phase 1b trial demonstrated good safety and tolerability of ascending doses of AM-201 as well as a dose-dependent reduction in weight gain in healthy volunteers treated with oral olanzapine at 10 milligrams for four weeks. At the highest AM-201 dose of 30 milligram the mean weight gain from baseline to the end of the treatment period was 2.8 kilograms compared against 3.7 kilogram in control subjects. The primary efficacy endpoint of mean reduction in weight gain was 0.9 kilogram and statistically significant with a p-value of less than 0.02. In the next step, following additional preclinical testing the company intends to file for an IND in 2021.
Moving to Slide 7. I will now discuss our newly established program [Indecipherable] for protection against airborne pathogens and allergens.
On to Slide 8. Last week, we announced the initiation of a new development program where we are aiming to develop a drug-free nasal spray for personal protection against airborne pathogens and allergens. The current worldwide pandemic have further highlighted the risks associated with airborne pathogens. The nose is the main port of entry for airborne viruses and bacteria. On normal conditions, human beings take in approximately 90% of air through their noses. And other risk is exposure to allergens such as those from pollen, animal hair or house dust mite, which affect many people. Close to 8% of the adult US population and 9% of