Irish biopharmaceutical firm Alkermes has commenced a supportive Phase III ENLIGHTEN-Early clinical trial of ALKS 3831 in young adults with schizophrenia, schizophreniform or bipolar I disorder.
ALKS 3831 is an investigational, oral atypical antipsychotic drug candidate currently being developed as a broad-spectrum treatment for schizophrenia.
The product contains a new molecular entity known as samidorphan, which is co-formulated in a single bilayer tablet with an established antipsychotic agent, olanzapine.
The multi-centre, randomised, double-blind Phase III trial is designed to compare the weight gain profile of once-daily ALKS 3831 with that of olanzapine over a period of 12 weeks in 250 patients who are early on in their illness.
Olanzapine is reported to result in metabolic liabilities such as significant weight gain, and ALKS 3831 is expected to deliver the former’s strong antipsychotic efficacy with a favourable safety profile, weight and metabolic properties.
Alkermes CEO Richard Pops said: “With a novel pharmacologic approach designed with the real-life needs of patients in mind, we believe that ALKS 3831 has the potential to have a meaningful impact on the treatment of schizophrenia, particularly in this young adult population that has demonstrated susceptibility to antipsychotic weight gain and who could benefit from a highly effective medicine early in the course of their disease.”
The ENLIGHTEN-Early trial will also evaluate the safety and tolerability of the drug candidate.
The subjects in the double-blind portion of the trial will also be eligible to participate in another open-label safety study that will be carried out for an additional 24 months.
The extension phase of the study will evaluate the long-term safety, tolerability and durability effects of once-daily, oral ALKS 3831.