American Journal of Psychiatry has published online results from a Phase IIb clinical trial of MIN-101 a proposed treatment for schizophrenia.- Minerva Neurosciences.
Minerva Neurosciences, Inc. announced that the American Journal of Psychiatry has published online results from its previously reported Phase IIb clinical trial of MIN-101. MIN-101 is a novel compound with affinities for sigma2 and 5HT2A receptors but no direct activity on dopamine receptors. In this regard, MIN-101 differs from drugs currently indicated for schizophrenia, all of which directly interfere with dopamine neurotransmission by antagonizing dopamine receptors.
The key finding from the publication is that MIN-101 achieved its primary outcome in the trial, demonstrating statistically significant superiority over placebo in improving negative symptoms in schizophrenia patients as measured by the pentagonal negative symptoms cluster of the Positive and Negative Syndrome Scale (PANSS). The improvement in negative symptoms was shown for both doses tested: 32 milligrams (mg): p = 0.024 effect size = 0.45, and 64 mg: p = 0.004 effect size = 0.57. Supporting these findings were similar and concomitant improvements on several secondary outcome measures, including PANSS cluster analyses of negative symptoms, the PANSS total score, the Clinical Global Impression (CGI) and the Brief Negative Symptom Scale (BNSS). Psychosis measured by the PANSS Positive symptoms subscale remained stable during the trial, suggesting that the improvement in negative symptoms associated with MIN-101 was specific and not a pseudo-effect secondary to improvements in psychosis. MIN-101 also demonstrated good tolerability, with no weight gain or other metabolic abnormalities, no clinically significant changes in vital signs, routine laboratory values, sedation and extra-pyramidal symptoms (EPS). The lack of observed adverse effects associated with MIN-101 treatment as compared to placebo helped to preserve the blinding of the trial, further supporting the validity and specificity of the improvement observed in negative symptoms.
Comment:The findings published in the American Journal of Psychiatry are noteworthy in that MIN-101 was shown to improve negative symptoms without blocking dopamine receptors, unlike other drugs indicated for schizophrenia. MIN 101 is currently in Phase III trials for schizophrenia.
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