The regulatory agency supports Auris’ plan to conduct multiple doses of AM-201 in a Phase 1 trial with healthy volunteers. The drug is in development to address negative side effects from an antipsychotic medication.

On Tuesday (November 20), Auris Medical (NASDAQ:EARS) announced the results of its pre-Investigational New Drug (IND) application meeting with the US Food and Drug Administration (FDA).

According to the release, the regulatory agency supports Auris’ plan to conduct multiple doses of AM-201 in a Phase 1 trial with healthy volunteers. The drug is in development to address negative side effects from an antipsychotic medication, olanzapine.

Olanzapine is an overall robust drug to treat schizophrenia and bipolar disorder, but side effects range from weight gain to fatigue. These shortcomings have limited doctors from prescribing the drug, Thomas Meyer, CEO of Auris told the Investing News Network (INN) in a phone interview.

Auris has been developing betahistine in two programs — for vertigo in AM-125 and Olanzapine-induced weight gain in AM-201. Meyer said the drug was once approved by the FDA decades ago, but was pulled in the early 70s and never brought back in. It was and is still used to treat dizziness, or vertigo.

Histamines play a role in the body to improve wakefulness, regulating appetite and plays a key role in balancing the vestibular system, he said. A major downside of this drug — in tablet form — is that it’s absorbed and broken down so quickly in the body that little is absorbed into the bloodstream.

Auris has reformulated the drug as a nasal spray. In preclinical models, it has shown to be absorbed into the bloodstream at higher concentrations. “This should translate into much higher, or better efficacy,” Meyer said.

For olanzapine, the drug causes patients to gain anywhere from 4-5 kg (8.8-11 lbs) of weight a year on average. In other cases, patients can gain up to 10-20 kg (22-44 lbs) annually. The fatigue is another major side effect from the drug, both are caused by Olanzapine blocking these histamine receptors.

AM-201 acts as a histamine-agonist by lifting the block of the histamine receptor in the brain, brought on by drugs such as olanzapine.

A separate double-blind, placebo controlled study of over 50 patients was published at the end of October on similar research. Both the tablet form of the olanzapine and another antipsychotic drug clozapine were dosed in patients taking the drugs who had previously gained weight from the drugs. Weight gain was reduced by roughly 3 kg (6.6 lbs) for betahistine versus the placebo in the 12-week study.

Ultimately, Auris’ future clinical trials will prove if this is a viable option or not for patients with the weight gain. Auris presented its proposal for the Phase 1 trial, which consisted of patients already taking olanzapine to also use the nasal spray three times daily.

A Phase 1 clinical trial is expected to start in Q1 2019 in Europe with 50 healthy volunteers all placebo-controlled. Mitigating weight gain, drowsiness and ensuring patient safety will be a few objectives in the trial, among others.

Auris also received guidance on the regulatory pathway and future objectives for trials. Suggestions were also made, which Meyer said will be added to the upcoming trials. He said this meeting was timed appropriately to allow the guidance to be included well before the trial starts.

Despite the downsides of olanzapine, marketed as Zyprexa by Eli Lilly (NYSE:LLY), it is still one of the top schizophrenia-marketed drugs in the US. There are about 550,000 patients currently using the drug in the five largest countries in Europe, the US and Japan which are currently treated with the drug, Meyer said.

The drug had originally been developed for vertigo, a Phase 2 clinical trial is set to start for this indication also in Q1 2019. Meyer said some clinical trial data could be released for both this and the AM-201 program next summer.

Meyer said the company is also exploring other indication opportunities for its betahistine drug.

On November 15, Auris announced its plans to partner for its Phase 3 drug AM-111 for ASNHL, or sudden deafness. The company previously had a drug, Keyzilen, which failed in its second Phase 3 clinical trial. Meyer said the drug failed due to design issues and that this trial is currently on the sideline.

The company still believes the drug has potential.“Work will be done on a smaller scale than the Phase 3, to bring [the drug] back,” Meyer said.

Meyer started the company in 2003, and has led it with a focus on neurotology and mental health supportive care.

Investor takeaway

Auris Medical’s share price increased 36 percent over the trading period to US$0.68, as of market close on Tuesday.

According to TipRanks, last month Euro Pacific Capital analyst James Molloy initiated a “Buy” target for the company with a US$2.50 price target.

Milestones investors can look forward to is both clinical trials starting next quarter, and possible data readouts in the summer of the same year. Investors can follow news on the company’s site for additional highlights.

Don’t forget to follow@INN_LifeScience for real-time updates!

Securities Disclosure: I, Gabrielle Lakusta, hold no direct investment interest in any company mentioned in this article.

Editorial Disclosure: The Investing News Network does not guarantee the accuracy or thoroughness of the information reported in the interviews it conducts. The opinions expressed in these interviews do not reflect the opinions of the Investing News Network and do not constitute investment advice. All readers are encouraged to perform their own due diligence.


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