Key clinical studies of breakthrough drugs for schizophrenia have been successful

Sunovion Pharma, a U.S. subsidiary of Sunovion, Japan, recently announced that the results of sEP361-201, a four-week key study evaluating the treatment of schizophrenia with TAAR1 astrative SEP-363856, have been published in the New England Journal of Medicine (NEJM). The article is entitled: A Non-D2-Receptor-Binding Drug for The Treatment of Schizophrenia.The results showed significant improvement in the overall score of positive and negative symptom scales (PANSS) in the SEP-363856 treatment group compared to the placebo group. In the study, the effects of the SEP-363856 treatment group and the placebo group on the symptoms, weight and other metabolic parameters (blood lipids, glycified hemoglobin, oxytocin, etc.) in the cone's outer system were similar.SEP-363856 is a TAAR1 agonist that has been approved by the FDA as a breakthrough drug for schizophrenia (BTD), which has the potential to become the first new antipsychotic drug not to treat schizophrenia by combining dopamine D2 subjects.

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A 4-week, randomized, double-blind, parallel group, placebo-controlled, flexible dose, and multi-center study published in EJM evaluated the efficacy and safety of SEP-363856 in adult patients with acute schizophrenia. In the study, patients were randomly grouped at a 1:1 scale and received 1 daily SEP-363856 (50 mg or 75 mg) or placebo treatment for 4 weeks. Changes in the total score of positive and negative symptoms (PANSS; range: 30 to 210 points; higher scores indicating more severe psychotic symptoms) at week 4 of primary endpoint therapy relative to the baseline. The study had eight secondary endpoints, including changes in the clinical overall impression-severity scale (CGI-S) and the concise negative symptom scale (BNSS) score relative to the baseline. In the study, a total of 120 patients were assigned to the SEP-363856 treatment group, 125 patients were assigned to the placebo group, and the average PANSS score at the baseline of the two groups was 101.4 and 99.7 points, respectively.The results showed that the total score of positive and negative symptoms (PANSS) in the SEP-363856 daily elastic dose (50-75 mg) was statistically and clinically significantly improved compared to the placebo group in week 4 of treatment (-17.2 vs -9.7; p-0.001). Compared to the placebo group, the SEP-363856 treatment group also showed improvement in the clinical overall impression-severity scale (CGI-S) (p<0.001). In addition, improvements were made in all major PANSS (positive, negative and general psychiatry) score tables (p<0.02). Adverse events treated by SEP-363856 include drowsiness and gastrointestinal symptoms. Throughout the study, SEP-363856 had good tolerance, and the total stop rate of SEP-363856 and placebo groups was comparable. The rates of symptoms in both groups were similar to changes in blood lipids, glycoglobin and oxytocin levels.

"These data represent an exciting step forward in schizophrenia research," said Dr. John Krystal, M.D., co-author of the NEJM paper and chairman and co-director of the Yale Clinical Research Center at Yale University School of Medicine. Targeting TAAR1 is a new mechanism for treating schizophrenia and represents a brave and innovative approach to schizophrenia treatment. For the past 60 years, antipsychotic drugs combined with dopamine receptors have been the standard treatment for schizophrenia, despite their side effects. Key clinical findings published this time support the potential of SEP-363856 as a new treatment for schizophrenia, which has the potential to have a significant positive impact on the public health burden of schizophrenia patients, their families, and schizophrenia. Schizophreniais a chronic, severe and often severely disabling mental illness that affects more than 23 million people worldwide. In the United States, there are about 2.4 million adults with schizophrenia, equivalent to one in 100 adults. Schizophrenia has a variety of clinical manifestations, characterized by positive symptoms (e.g. hallucinations, delusions, unsymulative thinking), negative symptoms (e.g. lack of emotion, social withdrawal, lack of spontaneity), cognitive impairment (memory, attention and planning, organizational and decision-making problems). Acute episodes of schizophrenia are characterized by psychotic symptoms, including hallucinations and delusions, which often require hospitalization. The disease is chronic and lifelong, often accompanied by depression and a gradual deterioration in social function and cognitive abilities.SEP-363856 is a novel trace amine-related subject 1 (TAAR1) astigtor with 5-serotonin 1A (5-HT1A) astigtor activity, which is currently being evaluated in patients with schizophrenia. SEP-363856 does not bind to dopamine 2 (D2) or 5-serotonin 2A (5-HT2A) subjects, which are thought to mediat the role of atypical antipsychotic drugs currently available. Currently, the treatment of schizophrenia by SEP-363856 is being studied in DIMOND, a Phase III global development project, and Roommate Pharmaceuticals is considering other adaptations to the drug. In the United States, the FDA granted SEP-363856 A Breakthrough Drug Qualification (BTD) for schizophrenia in May 2019.Dr Kenneth Koblan, Sunovion's chief scientific officer, said: "These findings, published in the New England Journal of Medicine, show that SEP-363856 has the potential to be the first TAAR1 astiotheria to treat schizophrenia. With more than 23 million people with schizophrenia worldwide, SEP-363856 is an innovative approach that will provide them with a whole new treatment option. Alleyou Pharmaceuticals is committed to developing new treatment options for these patients and continues to study SEP-363856 to further evaluate its clinical efficacy for schizophrenia and other neuropsychiasts.as noted in the NEJM article, in the six-month open label extension study, SEP-363856 showed continuous improvement in efficacy indicators, including PANSS scores, CGI-S scores, short negative symptom scale (BNSS) totals, and appeared to be safe and sustainable. (
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