Minerva Neurosciences, a Waltham, Mass.-based clinical-stage biopharmaceutical company focused on the development of therapies to treat central nervous system (CNS) disorders, has announced that the FDA has accepted the company’s Investigational New Drug (IND) application for MIN-101, a first-in-class 5-HT2a and sigma2 antagonist in clinical development for the treatment of schizophrenia.
In addition, the company announced the completion of the enrollment of a total of 244 patients in a randomized, placebo-controlled double-blind European phase IIb clinical trial of MIN-101. The primary objective of the trial is to evaluate the efficacy of MIN-101 compared to placebo in improving the negative symptoms of schizophrenic patients. Additional objectives include the assessment of cognitive symptoms and overall symptomatology of the disease following treatment with MIN-101. Topline results from the core 12-week treatment evaluation period are expected in the second quarter of 2016.
“Acceptance of the IND for MIN-101 is an important step toward the initiation of advanced-stage clinical testing of this compound in the U.S. following the results of our ongoing phase IIb trial in Europe,” said Remy Luthringer, president and chief executive officer of Minerva. “We will be continuing our dialogue with the FDA as part of our overall planning for late-stage clinical testing in the U.S.”