Minerva (NERV) Provides Phase III Development Strategy For MIN-101
Zacks Investment Research | May 16, 2017 06:02AM ET
Minerva Neurosciences, Inc. (NASDAQ:NERV) announced plans for its phase III and phase IV clinical development of pipeline candidate MIN-101. MIN-101 is being evaluated for the treatment of negative symptoms of schizophrenia. The company made this announcement following an "end-of-Phase II” meeting with the FDA.
Minerva’s share price has declined 29.3% year to date, while the Zacks classified Medical-Drugs industry witnessed a gain of 7.2%.
The company plans to initiate the phase III study of MIN-101 in the second half of 2017. The data from the phase IIb study with MIN-101 have led to the design of the 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 study will be followed by an optional 36-week extension phase in which all patients will receive MIN-101. The study is expected to enroll 500 patients at about 60 clinical sites across the U.S. and Europe.
The primary phase III trial endpoint of improvement in negative symptoms at 12 weeks will be measured by the PANSS negative sub-scale score using the Marder factor. Secondary efficacy endpoints will include the Clinical Global Impression of Severity (CGI-S) scale and Personal and Social Performance (PSP) total score.
The phase III study is similar to the phase IIb study which met its primary endpoint. The phase II b study showed improvement in schizophrenic patients with negative symptoms treated with MIN-101 compared to placebo. The phase IIb study was completed in 2016.
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.
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.
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Zacks Rank & Stocks to Consider
Minerva currently carries a Zacks Rank #3 (Hold). Some better ranked stocks in the health care sector include VIVUS, Inc. (NASDAQ:VVUS) , MEI Pharma, Inc. (NASDAQ:MEIP) and Aeglea BioTherapeutics (NASDAQ:AGLE) . While VIVUS and MEI Pharma sport a Zacks Rank #1 (Strong Buy), Aeglea carries a Zacks Rank #2 (Buy). You can see .
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MEI Pharma’s estimates narrowed from loss per share of 1 cent to gain per share of 1 for 2017 over the last 60 days. The company posted positive earnings surprises in three of the four trailing quarters, with an average beat of 66.56%.
Aeglea’s loss per share estimates narrowed from $3.64 to $2.48 for 2017 over the last 60 days. The company posted positive earnings surprises in three of the four trailing quarters, with an average beat of 20.75%.
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