New drugs for depression! Caplyta Assisted Treatment of Bisteal Depression Phase III Success: Significantly Improves Depressive Symptoms and Severity!

!--webeditor: page title" -- Bi-phase disorder (Photo: md-health.com) September 10, 2020 // -- Intra-Cellular Therapies (ICT) is a biopharmaceutical company focused on the development of innovative therapies to treat central nervous system (CNS) diseases.
, the company recently published positive top-line results from a Phase III clinical trial that evaluated Capallyta as an ad-assisted therapy for lithium salts or valproates to treat severe depressive episodes associated with biphasic type I or bisych type II disorder.
results showed that lumateperone 42 mg per day significantly improved depressive symptoms compared to placebo, with statistically significant results at the main endpoints (improved depression, p.0206) and key secondary endpoints (improved depression severity, p.0082).
jumped 74 per cent after the data was released.
Caplyta was approved by the U.S. Food and Drug Administration (FDA) in December 2019 for the treatment of adult patients with schizophrenia.
Based on the results of the 401 study, as well as the previously published single-drug therapy Phase III 404 study, ICT plans to submit a supplementary new drug application (sNDA) to the FDA by the end of 2020 or early 2021, using Caplyta as a single-drug therapy and complementary therapy for the treatment of bisceptic depression in patients with bisopleceal type I or type II disorders.
402 was conducted in five countries around the world, including the United States.
study, 529 patients with moderate to severe depressive episodes with biphasia I or bisoplex II disorder were randomly assigned a 1:1:1 ratio to take lumateperone 42 mg, 28 mg, placebo, and continue to use lithium salts or valproate as mood stabilizers.
results showed that lumateperone 42mg reached the primary endpoint: in week 6 of treatment (trial endpoint), the total score of Montgomery and Asperger's Depression Scale (MADRS) was evaluated relative to the baseline, and the lumateperone 42mg group showed significant statistically significant improvements in improving depression compared to the placebo group.
In the intentional therapy (ITT) study group, the average decrease in the minimum squares (LS) of the lumateperone 42 mg group relative to the baseline was 16.9 points, and the placebo group was 14.5 points (LS average difference was 2.4 points, the effect size was 0.27, p was 0.0206).
addition, the lumateperone 42mg group also reached a key secondary endpoint: a statistically significant improvement in the depression score of the Clinical General Impression-Bisplein Disorders Table of Disease Severity (CGI-BP-S) (p=0.0082; Effect size=0.31).
the study, the lumateperone 28mg group showed a dose-related improvement trend in depressive symptoms compared to the placebo group, but the results were not statistically significant.
, however, there was a statistically significant improvement in the 28mg group of lumateperone on CGI-BS-S compared to the placebo group.
the trial, lumateperone was well-to-do and safe.
adverse events were mild to moderate, similar to those seen in previous studies of biplex depression and schizophrenia, and no new adverse events were observed.
most common adverse events (with a rate of more than 5% and at least twice as high as placebo) were drowsiness, dizziness and nausea.
of restlessness, conical external symptoms, and weight changes were similar to placebos.
these findings provide further evidence to support the good safety and tolerance of luteperone in different patient groups.
the molecular structure of Lumentperone (Source: Wikipedia) Bipolar Type I and Bipolar Type II Affective Disorders are serious, highly prevalent mental illnesses.
these diseases are characterized by recurrent mania or mild mania mixed with severe depressive episodes called bipolar depression.
bipolar I and bipolar II each accounted for half of the total number of patients with bipolar disorder.
bipolar depression is the most common clinical manifestation of bipolar disorder.
these episodes tend to last longer, have a higher recurrence rate, and have a worse prognostic prognostic period than manic/mild mania attacks.
biscep depression remains a seriously inadequate medical need, with only a few FDA-approved treatments available, often associated with toestive problems.
Caplyta's active drug ingredient is lumateperone, a pioneering (first-in-class) small-molecule drug that selectively regulates three neurotransmitter paths involving severe mental illness: serotonin, dopamine, and glutamate.
pharmacological studies have shown that lumateperone, as a powerful antagonist, has high binding affinity on 5-serotonin 5-HT2A receptors, moderate binding affinity as an antagonist on post-synapse D2 receptors, and moderate affinity for D1 receptors as a 5-serotonin transporter (SERT) reuptake inhibitor with moderate affinity on D1 receptors (which may help to activate AMPA and NMDA receptors indirectly).
these subjects are thought to play an important role in schizophrenia, bipolar disorder, depressive disorder and other neuropsychiasts.
in-body studies have shown that lumateperone has about 60 times more affinity to 5-HT2A receptors than D2 receptors.
the United States, the FDA granted Luteperone fast-track status in November 2017 for the treatment of schizophrenia.
addition to schizophrenia, ICT is also developing luteperone to treat biphonic depression, depression and other neuropsychiasts.
industry is bullish about Caplyta's prospects, with pharmaceutical market research firm Evaluate Pharma predicting caplyta's sales will reach $2 billion by 2026, half of which will come from schizophrenia and the other half from biplex depression.
() !--/ewebeditor:page--!--ewebeditor:page title"--the original source: Intra-Cellular Therapies Announces Positive Topline Results from Study 402 Evaluating Luperone as Adjunct Therapy patient with Bipolar Depression !--/ewebitor