Intra-Cellular Therapies Finds Euphoria in Bipolar Study Results

Intra-Cellular Therapies Inc. (NASDAQ: ITCI) was one of the biggest winners on Wednesday after the company announced positive results from its late-stage clinical trial in patients with bipolar disorder. The Phase 3 trial (Study 402) evaluated lumateperone as adjunctive therapy to lithium or valproate in the treatment of major depressive episodes associated with bipolar 1 or bipolar 2 disorder.

In Study 402, once-daily lumateperone 42 mg met the primary endpoint for improvement in depression as measured by change from baseline versus placebo on the Montgomery-Asberg depression rating scale total score. Lumateperone 42 mg also met the key secondary endpoint, the CGI-BP-S depression score. The lower lumateperone dose, 28 mg, showed a trend for a dose-related improvement in symptoms of depression but the results did not reach statistical significance.

At the same time, lumateperone demonstrated a favorable safety profile and was generally well tolerated in the trial. The most commonly reported adverse events that were observed at a rate greater than or equal to 5% and at least twice the rate of placebo were somnolence, dizziness and nausea.

Also, this trial, in conjunction with the previously reported positive Phase 3 (Study 404) trail, forms the basis for the firm’s supplemental New Drug Application (sNDA) for the treatment of bipolar depression in patients with bipolar 1 or 2 disorder as monotherapy and adjunctive therapy.

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Management expects to submit this sNDA to the FDA in late 2020 or early 2021. The company also is submitting the sNDA to expand lumateperone’s label to include a second major neuropsychiatric disorder. Management even noted that with this clinical milestone, lumateperone has shown further potential to benefit patients suffering from a range of serious mental health conditions in addition to schizophrenia.

Intra-Cellular stock traded up about 68% on Wednesday to $30.92, in a 52-week range of $6.75 to $43.56. The consensus price target is $45.25.

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