Intra-Cellular Therapies (NASDAQ:ITCI) is in the news Wednesday after announcing positive results from a recent study that sent ITCU stock soaring.
The good news comes from Intra-Cellular Therapies’ Phase 3 clinical trial of “lumateperone as adjunctive therapy to lithium or valproate in the treatment of major depressive episodes associated with Bipolar I or Bipolar II disorder.”
The clinical trial saw a 42mg dose of lumateperone a day improve cases of depression in patients with Bipolar I or Bipolar II disorder, which was the primary endpoint of the study. It also met its secondary endpoint, which was meeting a certain CGI-BP-S Depression Score.
Intra-Cellular Therapies also notes that the clinical trial went through without major adverse events. The most common side effects of the drug were somnolence, dizziness, and nausea.
Intra-Cellular Therapies points out that it did try a second dosage option of lumateperone at 28mg a day. However, the results from that were not statistically significant enough to warrant further development.
Dr. Roger McIntyre, Professor of Psychiatry and Pharmacology at the University of Toronto and Head of the Mood Disorders Psychopharmacology Unit at the University Health Network, Toronto, Canada, said the following about the study results.
“Lumateperone is the first treatment to demonstrate efficacy for bipolar depression as monotherapy and as adjunctive therapy to mood stabilizers in a study population including both Bipolar I and Bipolar II patients. This will be welcome news to the psychiatric community as there is a tremendous need for improved treatment options.”
ITCI stock was up 75.3% as of Wednesday afternoon.
On the date of publication, William White did not have (either directly or indirectly) any positions in the securities mentioned in this article.