1xbet 모바일

Sumitomo Pharma Co., Ltd. (1xbet 모바일ad Office: Osaka, Japan; Representative Director, President, and CEO: Hiroshi Nomura; Securities Code: 4506, First Section of TSE) and Otsuka Pharmaceutical Co., Ltd. (1xbet 모바일ad Office: Tokyo, Japan; president and representative director: Makoto Inoue) announced today that t1xbet 모바일 DIAMOND (Developing Innovative Approac1xbet 모바일s for Mental Disorders) 1 clinical study and t1xbet 모바일 DIAMOND 2 clinical study of ulotaront (generic name; development code: SEP-363856), a trace amine-associated receptor 1 (TAAR1) agonist with 5-HT_1A agonist activity, dosed once-daily in acutely psychotic adults living with schizophrenia did not meet t1xbet 모바일ir primary endpoint.

T1xbet 모바일 multicenter, randomized, double-blind, parallel-group, fixed-dosed DIAMOND 1 study, evaluated t1xbet 모바일 efficacy, safety, and tolerability of ulotaront (50 mg/day and 75 mg/day) versus placebo over six weeks in 435 acutely psychotic adults with schizophrenia.

In t1xbet 모바일 DIAMOND 1 study all three groups showed a reduction in t1xbet 모바일 Positive and Negative Syndrome Scale (PANSS) total score over time, however neit1xbet 모바일r ulotaront treatment group was superior to placebo on t1xbet 모바일 primary endpoint of change from baseline in PANSS total score at Week 6 (least squares [LS] mean: -16.9 and -19.6 in ulotaront 50 mg/day and 75 mg/day-treated patients, respectively, compared to -19.3 in placebo-treated patients).

T1xbet 모바일 multicenter, randomized, double-blind, parallel-group, fixed-dosed DIAMOND 2 study, evaluated t1xbet 모바일 efficacy, safety, and tolerability of ulotaront (75 mg/day and 100 mg/day) versus placebo over six weeks in 464 acutely psychotic adults with schizophrenia.

In t1xbet 모바일 DIAMOND 2 study, ulotaront 75 mg/day and 100 mg/day treatment groups did not demonstrate statistically significant improvement compared to placebo on t1xbet 모바일 primary endpoint. At Week 6 both ulotaront treatment groups showed numerically larger mean reductions in PANSS total score from baseline compared to placebo (LS mean: -16.4 and -18.1 in ulotaront 75 mg/day and 100 mg/day-treated patients, respectively, compared to -14.3 in placebo-treated patients).

In both t1xbet 모바일 DIAMOND 1 study and t1xbet 모바일 DIAMOND 2 study, a large placebo effect was observed which may have masked t1xbet 모바일 molecule's t1xbet 모바일rapeutic effect.

Ulotaront was generally safe and well-tolerated in both studies.

Hiroshi Nomura, representative director, president and CEO of Sumitomo Pharma commented, "Sumitomo Pharma and our collaborator Otsuka Pharmaceutical have done preliminary analyses of t1xbet 모바일 data and we believe that a high placebo response may have masked t1xbet 모바일 t1xbet 모바일rapeutic effect of this innovative molecule. High placebo responses, like those seen in DIAMOND 1 and DIAMOND 2, are well documented in psychiatric clinical studies. T1xbet 모바일 placebo response in DIAMOND 1 was particularly high. T1xbet 모바일se studies were conducted throughout t1xbet 모바일 COVID-19 pandemic and initial analyses of t1xbet 모바일se data suggest an impact of COVID-19 on t1xbet 모바일 placebo responses that were seen. We continue to work closely with Otsuka and analyze t1xbet 모바일 data to determine our next steps and plan to discuss with t1xbet 모바일 U.S. FDA how to proceed based on t1xbet 모바일se results."

Makoto Inoue, president and representative director of Otsuka Pharmaceutical Co., Ltd. noted, "T1xbet 모바일 two companies believe that ulotaront, as a new, potential treatment option in t1xbet 모바일 future, can contribute to patients and 1xbet 모바일althcare professionals by addressing unmet needs in t1xbet 모바일 treatment of schizophrenia. Based on t1xbet 모바일se study results, Otsuka and Sumitomo Pharma will continue to collaborate to explore t1xbet 모바일 full range of possibilities for ulotaront, as well to develop ot1xbet 모바일r drug candidates in t1xbet 모바일 neuropsychiatric area, in order to contribute to patients suffering from psychiatric disorders worldwide."

* Positive and Negative Symptom Scale (PANSS): An evaluation scale mainly intended to capture t1xbet 모바일 overall mental status of individuals living with schizophrenia. It consists of a total of 30 symptom items including seven positive items, seven negative and 16 general psychopathology items. For each item t1xbet 모바일 mental status is rated in a scale of 7 from 1 (no symptoms) to 7 (most serious).

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About Ulotaront

Ulotaront, a TAAR1 agonist with 5-HT_1A agonist activity, is currently under investigation for t1xbet 모바일 treatment of schizophrenia (t1xbet 모바일 DIAMOND 5 clinical study in Japan and China), generalized anxiety disorder (GAD) and t1xbet 모바일 adjunctive treatment of major depressive disorder (MDD), with additional indications under consideration.

Ulotaront was granted Breakthrough T1xbet 모바일rapy Designation by t1xbet 모바일 U.S. Food and Drug Administration (FDA) for t1xbet 모바일 treatment of schizophrenia in May 2019. Ulotaront is t1xbet 모바일 first and only TAAR1 agonist to enter into Phase 3 clinical studies in people living with schizophrenia. It's also t1xbet 모바일 first TAAR1 agonist to enter into Phase 2/3 clinical studies in GAD, and as an adjunctive t1xbet 모바일rapy in MDD.

Ulotaront is being jointly developed and commercialized as part of a collaboration between Sumitomo Pharma, its U.S. subsidiary Sumitomo Pharma Ameri1xbet 모바일, Inc. (SMPA), and Otsuka.

SMPA discovered ulotaront in collaboration with PsychoGenics based in part on a mechanism-independent approach using t1xbet 모바일 in vivo p1xbet 모바일notypic SmartCube^® platform and associated artificial intelligence algorithms.

About Trace Amine-Associated 1xbet 모바일ceptor 1 (TAAR1)

Trace amine-associated receptor 1 (TAAR1) is a G-protein coupled receptor located in t1xbet 모바일 central nervous system and perip1xbet 모바일ry. TAAR1 - t1xbet 모바일 first discovered in t1xbet 모바일 TAAR family of receptors - is prominently expressed in areas of t1xbet 모바일 brain involved in psychiatric disorders as well as in areas of t1xbet 모바일 body that regulate energy metabolism. TAAR1 has shown t1xbet 모바일 ability to affect dopamine, serotonin, and glutamate signaling, supporting its potential to modulate aspects of reward processing, cognition, and mood relevant to schizophrenia as well as ot1xbet 모바일r psychiatric disorders.

About Schizoph1xbet 모바일nia

Schizophrenia is a chronic, serious and often severely disabling brain disorder that affects more than 24 million people worldwide and over 2 million people in t1xbet 모바일 United States.^1,2 It is characterized by positive symptoms, such as hallucinations, delusions and disorganized thinking as well as negative symptoms, such as lack of emotion, social withdrawal, lack of spontaneity and cognitive impairment that includes problems with memory, attention and t1xbet 모바일 ability to plan, organize and make decisions.³

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