ITCI - Intra-Cellular Therapies Highlights Data Presentations at the American College of Neuropsychopharmacology Annual Meeting | Benzinga
Company presents positive results of a pre-specified patient population in Study 403 examining the effects of CAPLYTA® (lumateperone) in patients experiencing a major depressive episode with anxious distress and mixed features.
Company presents preclinical data on ITI-1549, our lead product candidate in our non-hallucinogenic psychedelics program in mood disorders and other psychiatric disorders.
NEW YORK, Dec. 05, 2023 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (NASDAQ:ITCI), a biopharmaceutical company focused on the development and commercialization of therapeutics for central nervous system (CNS) disorders, today announced data presentations at the American College of Neuropsychopharmacology (ACNP) 62nd Annual Meeting.
"We are pleased to present new analyses at ACNP showing the antidepressant effects of lumateperone in patients with anxious distress and mixed features which further strengthen our confidence in CAPLYTA's potential as a broad treatment for MDD and other mood disorders," said Dr. Suresh Durgam, Executive Vice President and Chief Medical Officer of Intra-Cellular Therapies. "In addition, we are excited to share preclinical data on our newly introduced non-hallucinogenic psychedelic development program."
Monday, December 4:
Poster M91: "Lumateperone in the Treatment of Patients With Major Depressive Disorder and Bipolar Disorder with Anxious Distress and Mixed Features"
The poster presented at ACNP reports on an important post-hoc analysis from Study 403 evaluating the antidepressant effects of lumateperone in a pre-specified subgroup of patients with mixed features exhibiting anxious distress (commonly known as anxious depression).
Lumateperone improved change from baseline for MADRS total score at Day 43 compared with placebo in all three populations with anxious distress: combined major depressive disorder (MDD)/bipolar depression population (6.1 point reduction v. placebo; Cohen's d effect size (ES) = 0.67), MDD individual population (6.8 point reduction v. placebo; ES= 0.79), and bipolar depression individual population (5.5 point reduction v. placebo; ES= 0.59). Greater improvements vs placebo in MADRS Total score occurred by Day 15 and persisted throughout the study. Similarly, in the Clinical Global Impression Scale-Severity (CGI-S) lumateperone was superior versus placebo in all three patient populations. Cohen-D effect sizes on the CGI-s ranged from 0.48 to 0.66.
In DSM-5 anxious distress is defined as the presence of ?2 anxious symptoms (feeling tense, feeling restless, difficulty concentrating, fearful something awful may happen, or feeling out of control) during the majority of days during the current or most recent major depressive episode. Using this definition, anxious distress was present in 73.9% in MDD and 54.3% in bipolar depression patients enrolled in the study, highlighting its high prevalence, consistent with the literature.
Inner tension is an item within the MADRS which is often used as a surrogate marker for anxiety. With respect to the MADRS inner tension single-item score, lumateperone improved change from baseline at Day 43 compared with placebo for all three populations with anxious distress, demonstrating the consistency of the results.
The data presented in this poster represent further analyses from Study 403. Study 403 evaluated lumateperone 42mg as monotherapy in the treatment of major depressive episodes in patients with MDD with mixed features and in patients with bipolar depression with mixed features. Topline results for Study 403 are shown in Poster M88 and described below.
Both DSM-5 specifiers, mixed features and anxious distress, are common in patients with MDD and bipolar depression and their presence is associated with more pernicious forms of depressive illness (symptom severity, more comorbidities, increased suicide risk) and poor treatment response. In this analysis, lumateperone improved depression symptoms and severity score versus placebo in patients with MDD or bipolar depression with anxious distress and mixed features.
Poster M131: "Discovery and Characterization of ITI-1549, a Novel Non-hallucinogenic Psychedelic For the Treatment of Neuropsychiatric Disorders"
We are developing novel non-hallucinogenic psychedelics that allow exploration of this psychoactive drug class in neuropsychiatric conditions including mood disorders without the liabilities of known psychedelics, such as induction of hallucinations and risks for cardiac valvular pathologies. The lead molecule in this program, ITI-1549, is advancing through IND enabling studies and is expected to enter human testing in late 2024 or early 2025.
This poster describes the in-vitro and in-vivo preclinical characterization of ITI-1549. In vitro, similar to known hallucinogenic psychedelics, ITI-1549 exhibits high affinity binding to 5-HT2a receptors. Functionally, ITI-1549 acts as an agonist at 5-HT2A receptors favoring postsynaptic signaling within the beta-arrestin pathway over G-protein coupled pathways.
Activation of the 5-HT2a receptor coupled Gq signaling pathway has been linked to hallucinogenic properties of psychedelic compounds. By preferentially activating the ...