Minerva Neurosciences, Inc. (NERV - Free Report) announced that it is on track to begin phase III studies on its key schizophrenia pipeline candidate MIN-101 in the second half of this year, as planned.
The company said that it has completed a bridging study to select a new and safer formulation of MIN-101, while using the same dose strengths used in phase IIb study for use in the scheduled phase III study. The company may also file an NDA with the same.
Additionally, the selected formulation showed no food effect while maintaining the overall safety and tolerability profile of the candidate as observed in the successfully completed phase IIb study.
The company expects to aggregate data from both the studies – phase IIb and phase III – to evaluate efficacy of MIN-101 as the used and new formulation has the same exposure. Moreover, the improved new formulation has the potential to enhance the safety profile of the candidate in phase III study.
The phase III trial design will be a 12-week, placebo-controlled, monotherapy study testing two doses of MIN-101 in patients with negative symptoms and a diagnosis of schizophrenia. The patients will be required to have stable negative and positive symptoms over several months prior to enrollment, with a specified minimum threshold baseline score on the Positive and Negative Syndrome Scale (PANSS) negative sub-scale in order to be eligible for the study.
The phase III study is similar to the phase IIb study, which met its primary endpoint. The phase IIb study showed improvement in schizophrenic patients with negative symptoms treated with MIN-101 compared to placebo. The phase IIb study was completed in 2016.
Based on positive data from the phase III study, along with the positive data from the phase IIb study, Minerva plans to file a new drug application with the FDA.
Moreover, the company plans to conduct additional trials to expand the profile of MIN-101. These may potentially include a study comparing the rate of psychosis relapses in patients treated with MIN-101, standard of care with antipsychotics or placebo.
However, the schizophrenia market is competitive as evident from declining sales of AstraZeneca plc’s (AZN - Free Report) Seroquel XR. Meanwhile, ACADIA Pharmaceuticals Inc. (ACAD - Free Report) and Alkermes plc (ALKS - Free Report) are also developing treatments for schizophrenia.
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