Alkermes Hones in on Schizophrenia with Aristada

- June 24th, 2019

Alkermes is aiming to treat patients with CNS disorders, in particular schizophrenia, with its product Aristada.

Alkermes (NASDAQ:ALKS) isn’t shying away from tackling the complexity of central nervous system (CNS) disorders. 

CNS disorders include conditions such as schizophrenia, depression, addiction and multiple sclerosis. Treating these conditions can often be difficult, because healthcare providers must conduct a number of tests to eliminate other conditions before a proper diagnosis is made.

Alkermes is aiming to treat patients who have CNS disorders, in particular schizophrenia, with its product Aristada. Blair Jackson, senior vice president of corporate planning, told the Investing News Network (INN) that the company is trying to tackle this condition “holistically.”

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As Jackson explained, Aristada is a long-acting injectable atypical antipsychotic therapy that has been approved by the US Food and Drug Administration (FDA) to treat schizophrenia in adults. The product is offered in multiple doses because the disease ranges in severity from patient to patient.

“Individual patients often require very, very different things, and this approach where (healthcare providers) give one dose to every patient and they’re going to be fine doesn’t really exist within the psych community,” he said. Jackson added that physicians also have the option of dosing Aristada monthly or every two months.

According to the National Institute of Mental Health, schizophrenia is a mental disorder with effects that include the disruption of thought processes, perceptions, emotions and social interactions. Its symptoms range from hallucinations and delusions to thought disorders and reduced expression of emotions.

At a global scale, MentalHelp.Net states that 1 percent of the population has been diagnosed with schizophrenia, while 1.2 percent of Americans — which translates to 3.2 million people — have been diagnosed with the disease.

Alkermes presented topline results of its ALKS-3831 clinical trial, called Enlighten-2, back in April. The six month study tested the efficacy, safety and tolerability of Aristada and Invega Sustenna in adult patients with schizophrenia.

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Prior to Enlighten-2, Alkermes tested the efficacy of ALKS-3831 in patients with schizophrenia, which then led to an agreement with the FDA to look at weight reduction in patients using ALKS-3831 versus those that are on olanzapine. Olanzapine, which is sold under the name Zyprexa, is an antipsychotic used to treat schizophrenia and bipolar disorder that has been criticized for causing weight gain.

According to Jackson, Enlighten-2 demonstrated a reduction in positive and negative syndrome scale total scores, meaning that ALKS-3831 was able to help control the symptoms of schizophrenia similarly to olanzapine over the course of the study. The ALKS-3831 study showed a significant reduction in weight gain when compared to patients on olanzapine throughout the study’s duration.

“Weight gain is one of the number one reasons why patients stop taking their medication,” Jackson said. “Olzanapine is well known to be one of the most efficacious atypical antipsychotics used, and (when) patients stop taking it (there are) situations like relapse, hospitalization and a lot of expensive and unhealthy outcomes.”

Jackson further added that patients in the ALKS-3831 trial maintained weight at a consistent level, meaning that patients can take the treatment without the fear of gaining weight.

“One of the things we were able to show with ALKS-3831 was that after four to six weeks where (patients) gain a little weight, as the patient stabilizes, the weight profile of the patients remains relatively flat,” he explained.

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While the company is largely focused on CNS disorders, Jackson said that Alkermes has a program called ALKS-4230 in its product pipeline, which is its first step into immuno-oncology.

The study, called Artistry-1, was advanced into the monotherapy expansion phase on June 12 in patients with renal cell carcinoma or melanoma.

“We’re at the Phase 1/2 of this program where we’re starting to move the drug into oncology patients, both as a monotherapy and as a combination therapy with contruda,” Jackson said. “We anticipate that as the year progresses, we’ll start to have some data both on the PKPD (pharmacokinetic/pharmacodynamic) response of our drug as well as some of the responses in oncology patients in a variety of different tumor lines.”

Jackson said that Alkermes can be a “hard company to get your arms around” due to the multiple components to its business, but noted that its pipeline — including ALKS-4230 — is an exciting upside for the company and investors.

Alkermes shares stood at US$21.61 as of market close on Monday (June 24), representing a 22.4 percent decrease since the start of the year.

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Securities Disclosure: I, Jocelyn Aspa, hold no direct investment interest in any of the companies 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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