NEW YORK - Intra-Cellular Therapies, Inc. (NASDAQ:ITCI), a biopharmaceutical company, announced today that its drug lumateperone 42 mg has shown positive results in a Phase 3 study as an adjunctive treatment for major depressive disorder (MDD). The study met its primary and key secondary endpoints with statistical significance.
The primary endpoint was the change from baseline at Week 6 on the Montgomery-Åsberg Depression Rating Scale (MADRS), where lumateperone achieved a 4.9 point reduction versus placebo. The key secondary endpoint, the Clinical Global Impression Scale for Severity of Illness (CGI-S), also showed significant improvement. Both measures indicated a sustained effect starting from Week 1 through Week 6.
Additionally, lumateperone was generally well-tolerated, with a safety profile consistent with previous trials. The most common adverse events were dry mouth, fatigue, and tremor, which were in line with those observed in treatments for bipolar depression and schizophrenia.
The study involved 485 patients who were randomly assigned to receive either lumateperone 42 mg plus an antidepressant or a placebo plus an antidepressant. The trial aimed to assess the efficacy and safety of lumateperone as an adjunctive therapy in patients with MDD who had an inadequate response to antidepressant therapy alone.
Dr. Sharon Mates, Chairman and CEO of Intra-Cellular Therapies, expressed confidence in lumateperone as a potential first-choice treatment across mood disorders, citing its robust efficacy results and favorable safety profile. Results from a second Phase 3 study, Study 502, are expected later in the second quarter of this year.
MDD is a severe and common mood disorder that affects millions and is a leading cause of disability worldwide. Current treatments often fail to achieve remission, highlighting the need for new therapies with better efficacy and tolerability.
The company will host a conference call and webcast today at 8:30 a.m. ET to discuss the study results.
This article is based on a press release statement.
InvestingPro Insights
Intra-Cellular Therapies (NASDAQ:ITCI) has recently captured the attention of the medical community with their positive Phase 3 study results. Investors tracking the company's financial health will find several key metrics from InvestingPro that offer a broader picture of the company's performance and market position.
The company's market capitalization stands at a robust $6.27 billion, reflecting significant investor confidence in its potential. Despite this, the company's P/E ratio remains negative at -44.35, signaling that analysts do not expect Intra-Cellular Therapies to be profitable within this fiscal year. This aligns with one of the InvestingPro Tips, which highlights that the company has not been profitable over the last twelve months.
On a more positive note, the company's liquid assets have surpassed its short-term obligations, suggesting a healthy liquidity position that could support ongoing research and development efforts. This is particularly relevant given the capital-intensive nature of the biopharmaceutical industry. Moreover, the company operates with a moderate level of debt, which is an encouraging sign for risk-averse investors.
Revenue growth has been impressive, with an 85.51% increase over the last twelve months as of Q4 2023. This suggests that the company's products are gaining traction in the market, which may bode well for future financial performance, especially as new treatments like lumateperone progress through clinical trials and potentially enter the market.
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