http://ir.minervaneurosciences.com/releasedetail.cfm?ReleaseID=1026381
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The primary Phase 3 trial endpoint of improvement in negative symptoms at 12 weeks will be measured by the PANSS negative sub-scale score using the Marder factor, a widely recognized instrument for quantifying severity of negative symptoms. The Marder negative sub-score is similar to the White negative sub-score used in the Phase 2b trial. The two factors differ from each other in that the Marder score has eliminated four items and added one on active social avoidance (G16 item). The Company is employing the Marder scale because this item has been shown to be well correlated with patients’ overall functional outcome.
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Is this good news? What does it mean?
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Cool. I love this board. I get info even before my google alerts.
I also found this interesting:
"In Phase 4 development, 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. In addition, the Company may conduct a trial in adolescents at high risk for schizophrenia who during the prodromal phase manifest negative symptoms. "
So it seems there may be some risk of relapse without an antipsychotic. But of course we’ll have to wait and see. They’re not testing this as an add on therapy, but if there is a high level of relapse it might have to be used as one. Another concern would be how much negative symptoms are impacted by participants going off their antipsychotics in order to participate in the study. If a large effect comes from that, it could make it difficult to tell the effects of MIN 101 vs a “med holiday”.
I’m excited about the prodrome study though because there are a limited number of studies on the prodrome.
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Any idea when this med might be available to the public? If it’s going to be put through 4 phases I’m guessing longer then the next couple of years?
The Company believes that the efficacy data from the Phase 3 trial, if positive, in addition to the Phase 2b data, may form the basis for the future submission of a New Drug Application (NDA) for MIN-101 to the FDA.
So they’ll try to bring it to market after phase 3.
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Thanks @everhopeful. So much for our boy iti 007, it seems. When do you think we’ll get better drugs? You think min101 will be the first to hit the market?
The 4th phase can be conducted after it’s on the market - although I suppose it doesn’t have to be, but they’ll probably want to make the med available as soon as the FDA says OK.
The average is 3 years for phase 3 but that includes development and recruitment and meetings with the FDA. They have already done some of that though so it won’t be a full 3 years for the study. Then a few years for the FDA review. Probably a total of 3-5 years, so 2020-2022. Possibly a bit less if they advance it quickly and there are no major health problems to make the FDA have to request more tests.
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Probably 3 years for min-101. For the USA that is. I wouldn’t write off iti-007 just yet either.
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Wow, that’s a ways away still. Too bad. I guess we’re stuck with the atypicals for a while longer.
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