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Thu, May 26, 9:18 AM| Thu, May 26, 9:18 AM | 1 Comment
Thu, May 26, 9:08 AM
- A Phase 2b clinical trial assessing Minerva Neurosciences' (NASDAQ:NERV) lead product candidate, MIN-101, in patients with negative symptoms of schizophrenia met its primary endpoint of a statistically valid improvement over placebo in improving negative symptoms.
- The effect, statistically significant for both the 32 mg and 64 mg doses, was measured by the pentagonal structure model (PSM) of the Positive and Negative Syndrome Scale (PANSS). Only the 64 mg dose achieved statistical significance as measured by PANSS total score, however.
- MIN-101 was safe and well-tolerated with no significant difference in side effects compared to placebo. Two patients out of the 162 (1.2%) who received MIN-101 discontinued treatment due to changes in a cardiac function metric called QTcF prolongation. Both were in the 64 mg cohort. No weight gain or extra-pyramidal symptoms were observed.
- Patients who completed the 12-week double-blind core phase of the trial were given the option to participate in a 24-week open-label extension phase during which they will receive either 32 mg or 64 mg of MIN-101. The extension phase should be completed in Q3.
- Negative symptoms comprise the main burden for schizophrenia sufferers because they are responsible for poor vocational and psychosocial functioning. These symptoms include lack of motivation and initiative and restricted personal interaction.
- The development of MIN-101, which principally binds to the receptors 5-HT2A and sigma 2, is ongoing.
- Shares are up 255% premarket on robust volume.
Mon, May 23, 12:48 PM
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Mon, Mar. 14, 7:33 AM
- Minerva Neurosciences (NASDAQ:NERV): Q4 EPS of -$0.34 misses by $0.03.
Dec. 29, 2015, 4:44 PM
- The FDA accepts for review the Investigational New Drug (IND) application from Minerva Neurosciences (NASDAQ:NERV) for lead product candidate MIN-101, a 5-HT2a and sigma2 antagonist, for the treatment of schizophrenia. Once cleared, the company may initiate advanced-stage clinical testing in the U.S.
- The company's European Phase 2b trial has reached its enrollment target of 244 participants. The objective is to assess the efficacy of MIN-101 versus placebo in improving the negative symptoms of schizophrenic patients. Top-line results are expected in Q2.
- Previously: Minerva Neuro provides update on clinical development of three candidates (Dec. 9)
Dec. 9, 2015, 9:19 AM
- Minerva Neurosciences (NASDAQ:NERV) updates investors on the clinical development of three of its product candidates:
- MIN-101: Patient enrollment target of 234 in its Phase 2a trial in schizophrenia will be hit later this month. Top-line results for the core 12-week treatment evaluation period should be available in Q2 2016. Patients who respond positively to treatment will have the opportunity to enter into a six-month active treatment extension period.
- MIN-202: Patient enrollment completed in two studies, insomnia disorder and adjunctive treatment of major depressive disorder (MDD). The Phase 2a insomnia trial is assessing MIN-202 in 26 patients without psychiatric co-morbidity. The primary endpoint is sleep efficiency as measure by polysomnography. The Phase 2b MDD study is evaluating MIN-202 in 48 patients who are receiving either diphenhydramine or placebo. The primary endpoint is safety. Secondary endpoints include assessments of depressive symptoms, cognition and sleep.
- MIN-117: Patient recruitment ongoing in a Phase 2a study in MDD. Target enrollment is 80. The study is comparing two doses of MIN-117 to paroxetine and placebo. The primary endpoint is the efficacy of MIN-117 in reducing depressive symptoms versus placebo. Top-line data are expected in H1 2016.
Nov. 5, 2015, 7:38 AM
- Minerva Neurosciences (NASDAQ:NERV): Q3 EPS of -$0.24 beats by $0.12.
Aug. 5, 2015, 7:38 AM
- Minerva Neurosciences (NASDAQ:NERV): Q2 EPS of -$0.27 beats by $0.14.