Alkermes plc (NASDAQ: ALKS) today presented positive results from a phase 1 study of ALKS 3831, a novel drug candidate for the treatment of schizophrenia, in an oral session at the 53rd Annual New Clinical Drug Evaluation Unit (NCDEU) Meeting in Hollywood, Fla. By combining a novel opioid modulator, ALKS 33, and olanzapine, an antipsychotic drug commercially available as ZYPREXA®, ALKS 3831 is designed to be a broad spectrum treatment for schizophrenia with the potential benefits of reduced weight gain associated with olanzapine and expanded utility in patients with schizophrenia and comorbid substance abuse.
In the phase 1 study, subjects who received once-daily, oral administration of ALKS 3831 for three weeks demonstrated significantly less weight gain compared to subjects taking olanzapine. Weight gain is a common and clinically relevant metabolic side effect of atypical antipsychotic medications, and olanzapine has one of the highest incidences and greatest amounts of weight gain among the widely prescribed products in this class of drugs. Data from the phase 1 study showed that ALKS 3831 had a safety and tolerability profile similar to that observed in the olanzapine-only treatment group.
Based on the positive results of the phase 1 study, Alkermes plans to initiate a phase 2 dose-ranging study of ALKS 3831 in mid calendar 2013. This study will evaluate ALKS 3831's safety and effects on metabolic outcomes, including weight gain, in patients with schizophrenia. Additional studies will investigate ALKS 3831 for the large number of patients with the dual diagnosis of schizophrenia and substance abuse, a group representing as many as 50% of patients with schizophrenia. A prior 400-patient phase 2 clinical study of ALKS 33, the opioid modulator in ALKS 3831, showed utility in reduction of heavy drinking in patients with alcohol dependence.
Elliot Ehrich, M.D., Chief Medical Officer of Alkermes commented, "We believe that the addition of the opioid modulating properties of ALKS 33 to olanzapine creates the opportunity for a broader spectrum schizophrenia treatment that may be a useful therapeutic option for physicians and patients in two important ways. First, we believe that ALKS 3831 has the potential to attenuate the clinically significant weight gain commonly seen with olanzapine, and diminishing this side effect could open its proven therapeutic benefits to a wider range of patients with schizophrenia. Second, we see potential applicability for the large number of patients with the dual diagnosis of schizophrenia and substance abuse - a group representing as many as half of patients with schizophrenia."