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.
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.