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Fly News Breaks for September 10, 2019
Sep 10, 2019 | 10:38 EDT
JPMorgan analyst Jessica Fye said she is surprised that shares of Intra-Cellular are lower following the announcement that the FDA does not plan to schedule an Advisory Committee meeting to discuss lumateperone for schizophrenia. She thinks the base-case interpretation of the ad com update is positive, as it potentially is a sign of the FDA's comfort with lumateperone's risk/benefit and suggests the agency is comfortable evaluating the drug without outside feedback. The analyst, who added that management characterized their FDA dialogue as "very constructive" and said that they feel positive about the ad com update, is incrementally positive on the likelihood of approval following the update and keeps an Overweight rating on Intra-Cellular shares.
News For ITCI From the Last 2 Days
Dec 12, 2019 | 07:35 EST
Intra-Cellular Therapies announced data featured during the 58th Annual Meeting of the American College of Neuropsychopharmacology held in Orlando, FL, December 8-11, 2019 included: "Lumateperone in the Treatment of Bipolar Depression: Results from a Randomized Clinical Trial". This poster presented data from the positive Phase 3 clinical trial of lumateperone for the treatment of patients with bipolar depression. Study 404 was conducted globally, including in the U.S., and included 381 patients randomized to receive lumateperone 42 mg or placebo once daily for six weeks. Lumateperone met its primary endpoint of change from baseline at Week 6 on the Montgomery-Asberg Depression Rating Scale total score versus placebo. In the intent-to-treat study population, the LS mean improvement from baseline for lumateperone 42 mg was 16.7 points, versus 12.1 points for placebo, for a 4.6-point difference between the two groups. Lumateperone also met the study's key secondary endpoint, Clinical Global Impression Scale for Bipolar for Severity of Illness Total Score. In addition, the CGI component that specifically assesses depression showed improvement with lumateperone versus placebo. This improvement was statistically significant as early as week 1, the first time point measured, and was maintained at every time point throughout the study. In subgroup analyses of both Bipolar I patients and Bipolar II patients, statistically significant improvements were seen versus placebo on the MADRS total score. These results were supported by statistically significant improvements on responder rates and remission rates, demonstrating the clinical meaningfulness of the primary outcome, with 51.1% of patients on lumateperone meeting MADRS response criteria versus 36.7% for placebo at Day 43. Additionally, 39.9% of patients on lumateperone were considered remitters versus 33.5% for placebo. The safety profile in this study was consistent with previously reported placebo-controlled and open-label studies in patients with schizophrenia. Lumateperone showed similar effects as placebo on assessments of body weight, metabolic parameters, extrapyramidal symptoms, and prolactin. Rates of akathisia, restlessness and extrapyramidal symptoms combined were less than 1% and similar to placebo. The most commonly reported adverse events that were observed at a rate greater than 5% and higher than placebo were somnolence and nausea. The rates of discontinuation due to treatment emergent adverse events for lumateperone were less than 5 percent. "Efficacy and Safety of Lumateperone 42 mg in the Treatment of Schizophrenia: A Pooled Analysis of Randomized Clinical Trials". This poster highlighted the clinical results of lumateperone 42 mg, including its safety and tolerability profile from the short-term controlled studies of lumateperone in the treatment of patients with acute exacerbations of schizophrenia. The poster included additional post-hoc pooled analyses that found lower rates of MetSy in patients treated with lumateperone than in patients treated with risperidone. In these double-blind, placebo-controlled studies of 4 to 6 weeks duration, patients were randomized to either lumateperone 42mg, risperidone 4mg or placebo. The percentage of patients meeting criteria for MetSy at baseline was similar across groups. At study endpoint, fewer patients on lumateperone met the MetSy criteria compared with the percentage on risperidone. Among those patients with MetSy at baseline, the percentage who no longer met criteria for MetSy after study treatment was nearly twice as high among patients treated with lumateperone as among patients treated with risperidone. Among patients without MetSy at baseline, the percentage that developed MetSy during study treatment with lumateperone was half that in risperidone-treated patients. "Additional Results from a 12-Month Open-Label Safety Study of Lumateperone in Patients with Stable Symptoms of Schizophrenia". Additional results from the lumateperone long-term safety study were presented. The data presented showed the safety of long-term lumateperone treatment was consistent with previously reported studies and associated with a low risk of metabolic, EPS, and prolactin side effects. Patients with stable schizophrenia symptoms continued to show improvement in PANSS scores with lumateperone treatment throughout the 1-year open-label study. Furthermore, in patients with schizophrenia and comorbid depression symptoms at baseline lumateperone 42 mg improved depressive symptoms.