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| Richard Pops--Courtesy of Alkermes |
When Alkermes ($ALKS) set out to develop ALKS 3831 for schizophrenia, it took a well-known antipsychotic--olanzapine--and combined it with a mu-opioid antagonist called samidorphan with an eye to controlling the disease without spurring the rapid weight gain that has bedeviled patients for years. Today, the company says it got the data it was looking for in Phase II and will now press ahead into a pivotal, late-stage program to see if they can replicate the results on a larger scale.
Investors rallied behind the news, driving Alkermes' shares up 5% in premarket trading on Wednesday.
Technically, the primary goal of the study was to establish that the combo was just as effective as olanzapine in controlling schizophrenia. And investigators say they achieved that objective--which wasn't too surprising given that they were using the standard therapy. Alkermes though also spelled out a 37% lower mean weight gain after 12 weeks of therapy and a 51% lower weight gain for a group of patients who had put on pounds during a week-long lead-in treatment period, hitting the key secondary goal in the study.
"We modeled this in animals," Alkermes CEO Richard Pops tells FierceBiotech. "It significantly reduced the weight gain, and we're reporting data from the 12-week portion of a 6-month study. We expect it to extend over time."
The company has been seeing the same effect consistently throughout its program for this drug, one of several that Alkermes has in the clinic, Pops adds. Now the CEO says they can pivot into Phase III this year confident that they should be able to provide additional data that mirrors the results they achieved in a large Phase II study that enrolled more than 300 patients.
The ALKS 3831 program is similar to other drugs in Alkermes' pipeline. The company, based in Ireland, doesn't go for the big home run hits in R&D. Instead, it looks at improving existing therapeutic approaches. In this case, he says, Alkermes is advancing a drug that has the potential to become a leading antischizophrenia therapy in a multibillion-dollar field currently dominated by troublesome generics.
"Olanzapine is considered one of the most efficacious atypical antipsychotics, yet it has one of the highest incidences and greatest amounts of weight gain among the widely prescribed products in this class of drugs, severely limiting its clinical use," said Dr. Peter Weiden, a professor of psychiatry at the University of Illinois Medical Center. "This study showed very promising results for ALKS 3831 in addressing the major drawback of weight gain in patients treated with olanzapine, and it offers the potential for widening the therapeutic use of an olanzapine agent to meet the needs of patients."
- here's the release