Auris Medical Announces Positive Interim Results from AM-201 Phase 1b Study in Antipsychotic-Induced Weight Gain


Hamilton, Bermuda, Oct. 11, 2019 (GLOBE NEWSWIRE) -- 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, today announced positive interim results from its Phase 1b trial with AM-201 in antipsychotic-induced weight gain and somnolence. The study demonstrated good safety and tolerability of AM-201 over the four-week treatment period and revealed relevant reductions in olanzapine-induced weight gain and daytime sleepiness. In female study participants, who overall showed more pronounced changes than male participants, a reduction in weight gain of 1.1 kg against placebo was observed at the highest tested dose of 20 mg three times per day (probability of effectiveness = 90%). The study will now proceed to the next higher and final dose level of 30 mg to be tested on 30 healthy volunteers.

“We are very pleased to see the good safety and tolerability of intranasal betahistine confirmed over an extended period of time and are encouraged by the first efficacy signals observed in the indication of antipsychotic-induced weight gain and somnolence prevention“, commented Thomas Meyer, Auris Medical’s founder, Chairman and CEO. “We look forward to confirming and expanding these results in a larger dose cohort in the second leg of the study, for which we anticipate a data read-out towards the end of the first quarter of 2020.”  

“Weight gain and somnolence are major side effects of olanzapine and other antipsychotic medications and often inflict a major burden on the health and quality of life of patients”, stated Nir Barak, MD, member of Auris Medical’s Scientific Advisory Board. “Olanzapine is still considered one of the most efficacious antipsychotic drugs, yet its clinical use is often restricted due to the risk of substantial weight gain and metabolic adverse effects such as impaired glucose tolerance, new onset diabetes, hyperlipidemia or cardiovascular disease. A major cause of the weight gain associated with the use of olanzapine and many other antipsychotic drugs is the inhibition of the histamine H1 receptor, which betahistine seeks to counteract.”   

The Phase 1b trial with AM-201 in antipsychotic-induced weight gain and somnolence is being conducted at a single trial site in Europe and has enrolled 50 healthy volunteers to date. Participants received either AM-201 (1, 2.5, 5, 10 or 20 mg) or placebo three times a day in parallel with oral olanzapine (10 mg) once a day for four weeks. The primary efficacy outcome for the trial is the reduction in olanzapine-induced weight gain; the secondary efficacy outcome is the reduction in olanzapine-induced daytime sleepiness.

About Betahistine

Betahistine is a small molecule structural analog of histamine, which acts as an agonist at the H1 and as an antagonist at the H3 histamine receptors. Unlike histamine, it crosses the blood-brain-barrier. It is known to enhance inner ear and cerebral blood flow, increase histamine turnover and enhance histamine release in the brain, increase release of acetylcholine, dopamine and norepinephrine in the brain and to result in general brain arousal. Betahistine for oral administration is approved in about 115 countries, with the US being a notable exception, for the treatment of vertigo and Meniere’s disease. The compound has a very good safety profile, yet it is also known that its clinical utility is held back by poor bioavailability. Intranasal administration of betahistine has been shown to result in 5 to 29 times higher bioavailability.

About AM-201

Intranasal betahistine is being developed under project code AM-201 for the prevention of antipsychotic-induced weight gain and somnolence. Many antipsychotic drugs are known to block the H1 histamine receptor, which is involved in the control of appetite and wakefulness, resulting in weight gain and somnolence as side effects. As an H1 receptor agonist, betahistine is thought to counteract the antipsychotics’ inhibitory effects; in addition, betahistine blocks presynaptic H3 histamine autoreceptors, thus increasing histamine release and in turn augmenting betahistine’s direct agonistic effects on H1 receptors.

About Auris Medical

Auris Medical is a biopharmaceutical company dedicated to developing therapeutics that address important unmet medical needs in neurotology and central nervous system disorders. The company is focused on the development of intranasal betahistine for the treatment of vertigo (AM-125) and for the treatment of antipsychotic-induced weight gain and somnolence (AM-201). These projects have gone through two Phase 1 trials and entered into proof-of-concept studies in 2019. In addition, Auris Medical has two Phase 3 programs under development: Sonsuvi® (AM-111) for acute inner ear hearing loss and Keyzilen® (AM-101) for acute inner ear tinnitus. The Company was founded in 2003 and is headquartered in Hamilton, Bermuda. The shares of Auris Medical Holding Ltd. trade on the NASDAQ Capital Market under the symbol “EARS.”

Forward-looking Statements

This press release may contain statements that constitute “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements are statements other than historical facts and may include statements that address future operating, financial or business performance or Auris Medical’s strategies or expectations. In some cases, you can identify these statements by forward-looking words such as “may,” “might,” “will,” “should,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “projects,” “potential,” “outlook” or “continue,” or the negative of these terms and other comparable terminology. Forward-looking statements are based on management’s current expectations and beliefs and involve significant risks and uncertainties that could cause actual results, developments and business decisions to differ materially from those contemplated by these statements. These risks and uncertainties include, but are not limited to, Auris Medical’s need for and ability to raise substantial additional funding to continue the development of its product candidates, the timing and conduct of clinical trials of Auris Medical’s product candidates and that such trials will not meet their endpoints , the clinical utility of Auris Medical’s product candidates, the timing or likelihood of regulatory filings and approvals, Auris Medical’s intellectual property position and Auris Medical’s financial position, including the impact of any future acquisitions, dispositions, partnerships, license transactions or changes to Auris Medical’s capital structure, including future securities offerings. These risks and uncertainties also include, but are not limited to, those described under the caption “Risk Factors” in Auris Medical’s Annual Report on Form 20-F for the year ended December 31, 2018 and future filings with the Securities and Exchange Commission. Forward-looking statements speak only as of the date they are made, and Auris Medical does not undertake any obligation to update them in light of new information, future developments or otherwise, except as may be required under applicable law. All forward-looking statements are qualified in their entirety by this cautionary statement.

Investor contact:
Joseph Green
Edison Advisors for Auris Medical