A poster presentation (W54) entitled, “Lumateperone Improves Negative Symptoms Related to Emotional Experience (Avolition) in Patients with Schizophrenia” is being presented Wednesday, May 30, 2018, 11:15 am - 1:00 pm ET. This poster will be presented by Dr. Philip D. Harvey, Leonard M. Miller Professor of Psychiatry and Behavioral Sciences at the University of Miami Miller School of Medicine.
A poster presentation (T54) entitled, “A Novel Approach to Address an Unmet Need in the Treatment of Schizophrenia and Depression: Lumateperone, an Innovative Modulator of Dopamine, Serotonin, and Glutamate” is being presented Thursday, May 31, 2018, 12:30 pm - 2:00 pm ET. This poster will be presented by Dr. Kimberly E. Vanover, Senior Vice President of Clinical Development, Intra-Cellular Therapies.
https://globenewswire.com/news-release/2018/05/29/1513111/0/en/Intra-Cellular-Therapies-Announces-Presentations-on-Lumateperone-at-the-American-Society-of-Clinical-Psychopharmacology-ASCP-Annual-Meeting.html
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thanks for this twinklestars. do u know where i can watch?
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No, sorry. I don’t know if it’s public. But if anyone finds it, please post!
Thank you for posting @twinklestars!
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Intra-Cellular Therapies, Inc. (Nasdaq:ITCI), a biopharmaceutical company focused on the development of therapeutics for central nervous system (“CNS”) disorders, today announced that Sharon Mates, Ph.D., Chief Executive Officer and Chairman, is scheduled to present at the Jefferies 2018 Global Healthcare Conference in New York, NY. The presentation is scheduled for Wednesday, June 6, 2018 at 4:30 pm ET.
Probably be a few years before private insurance will want to cover it. Medi-cal probably won’t cover it.
Here’s some more info:
https://www.streetinsider.com/dr/news.php?id=14255411
“All negative symptoms do not have the same impact on functional outcomes and the domain of symptoms (emotional experience) improved by lumateperone are the most important predictors of social dysfunction in schizophrenia. The fact that lumateperone selectively improves these negative symptoms suggests the potential for improved social outcomes in people with schizophrenia,” said Dr. Philip D. Harvey, Leonard M. Miller Professor of Psychiatry and Behavioral Sciences at the University of Miami Miller School of Medicine.
While positive symptoms such as hallucinations, delusions, and suspiciousness can be effectively addressed by existing antipsychotics, negative symptoms such as emotional withdrawal and co-morbid symptoms of depression are common in the disorder yet not effectively treated. Moreover, interpersonal relationships and social function remain challenging for many people living with schizophrenia. The Company believes that lumateperone has the potential to treat symptomatology known to favorably impact social function and, thereby, significantly improve quality of life and better allow individuals living with schizophrenia to reintegrate into society."
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And were moving closer to Mid-2018, I am kinda excited.
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yes please let me become social again!
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If its that good, they might get Accelerated Approval, after sending the NDA to FDA.
Our clinical development program for the treatment of schizophrenia with lumateperone includes three large randomized, double-blind, placebo-controlled trials. In two studies, ITI-007 60 mg showed a statistically significant separation from placebo on the primary endpoint
im not getting too high on it, just 2/3 studies showed improvement
To be fair, the 3rd study also showed improvement, but they had an unusually high placebo response.
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I was just about to write that down, but was looking for the web-page.
This isn’t the first time that Intra-Cellular has seen its share tumble on lumateperone study results. Data from a late-stage study of the drug, previously known as ITI-007, showed that neither dose of lumateperone studied proved better than placebo in patients with schizophrenia. This was blamed on an “an unusually high placebo response at certain sites,” however, the comparator Risperdal (risperidone) arm seemed to show higher efficacy than placebo, which rather muddies the waters
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Yep. But, the safety question was apparently resolved, as it had to do with how dogs metabolized the drug, and people didn’t metabolize it the same way.
And the FDA has said the high placebo response in the one study does not preclude them from submitting an NDA.
But, they do have to prove it works, so it’s good that they have several other studies ending soon.
This new generation of AP, if this goes well, everything will go sky-high. And it doesn’t end there, they will find more information on how it work and might find the source of schizophrenia.
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