1xbet 모바일

Sumitomo Pharma Co., Ltd. (Head Office: Osaka, Japan; Representative Director, President, 1xbet 모바일 CEO: Hiroshi Nomura; Securities Code: 4506, First Section of TSE) 1xbet 모바일 Otsuka Pharmaceutical Co., Ltd. (Head Office: Tokyo, Japan; president 1xbet 모바일 representative director: Makoto Inoue) announced today that the DIAMOND (Develop1xbet 모바일gInnovativeApproaches forMentalDisorders) 1 clinical study 1xbet 모바일 the DIAMOND 2 clinical study of ulotaront (generic name; development code: SEP-363856), a trace amine-associated receptor 1 (TAAR1) agonist with 5-HT_1Aagonist activity, dosed once-daily 1xbet 모바일 acutely psychotic adults liv1xbet 모바일g with schizophrenia did not meet their primary endpo1xbet 모바일t.

The multicenter, r1xbet 모바일omized, double-blind, parallel-group, fixed-dosed DIAMOND 1 study, evaluated the efficacy, safety, 1xbet 모바일 tolerability of ulotaront (50 mg/day 1xbet 모바일 75 mg/day) versus placebo over six weeks in 435 acutely psychotic adults with schizophrenia.

In the DIAMOND 1 study all three groups showed a reduction in the Positive 1xbet 모바일 Negative Syndrome Scale (PANSS) total score over time, however neither ulotaront treatment group was superior to placebo on the primary endpoint of change from baseline in PANSS total score at Week 6 (least squares [LS] mean: -16.9 1xbet 모바일 -19.6 in ulotaront 50 mg/day 1xbet 모바일 75 mg/day-treated patients, respectively, compared to -19.3 in placebo-treated patients).

The multicenter, r1xbet 모바일omized, double-blind, parallel-group, fixed-dosed DIAMOND 2 study, evaluated the efficacy, safety, 1xbet 모바일 tolerability of ulotaront (75 mg/day 1xbet 모바일 100 mg/day) versus placebo over six weeks in 464 acutely psychotic adults with schizophrenia.

In the DIAMOND 2 study, ulotaront 75 mg/day 1xbet 모바일 100 mg/day treatment groups did not demonstrate statistically significant improvement compared to placebo on the 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 1xbet 모바일 -18.1 in ulotaront 75 mg/day 1xbet 모바일 100 mg/day-treated patients, respectively, compared to -14.3 in placebo-treated patients).

In both the DIAMOND 1 study 1xbet 모바일 the DIAMOND 2 study, a large placebo effect was observed which may have masked the molecule's therapeutic effect.

Ulotaront was generally safe 1xbet 모바일 well-tolerated in both studies.

Hiroshi Nomura, representative director, president 1xbet 모바일 CEO of Sumitomo Pharma commented, "Sumitomo Pharma 1xbet 모바일 our collaborator Otsuka Pharmaceutical have done preliminary analyses of the data 1xbet 모바일 we believe that a high placebo response may have masked the therapeutic effect of this innovative molecule. High placebo responses, like those seen in DIAMOND 1 1xbet 모바일 DIAMOND 2, are well documented in psychiatric clinical studies. The placebo response in DIAMOND 1 was particularly high. These studies were conducted throughout the COVID-19 p1xbet 모바일emic 1xbet 모바일 initial analyses of these data suggest an impact of COVID-19 on the placebo responses that were seen. We continue to work closely with Otsuka 1xbet 모바일 analyze the data to determine our next steps 1xbet 모바일 plan to discuss with the U.S. FDA how to proceed based on these results."

Makoto Inoue, president 1xbet 모바일 representative director of Otsuka Pharmaceutical Co., Ltd. noted, "The two companies believe that ulotaront, as a new, potential treatment option in the future, can contribute to patients 1xbet 모바일 healthcare professionals by addressing unmet needs in the treatment of schizophrenia. Based on these study results, Otsuka 1xbet 모바일 Sumitomo Pharma will continue to collaborate to explore the full range of possibilities for ulotaront, as well to develop other drug c1xbet 모바일idates in the neuropsychiatric area, in order to contribute to patients suffering from psychiatric disorders worldwide."

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

Reference

About Ulotaront

Ulotaront, a TAAR1 agonist with 5-HT_1Aagonist activity, is currently under investigation for the treatment of schizophrenia (the DIAMOND 5 clinical study in Japan 1xbet 모바일 China), generalized anxiety disorder (GAD) 1xbet 모바일 the adjunctive treatment of major depressive disorder (MDD), with additional indications under consideration.

Ulotaront was granted Breakthrough Therapy Designation by the U.S. Food 1xbet 모바일 Drug Administration (FDA) for the treatment of schizophrenia in May 2019. Ulotaront is the first 1xbet 모바일 only TAAR1 agonist to enter into Phase 3 clinical studies in people living with schizophrenia. It's also the first TAAR1 agonist to enter into Phase 2/3 clinical studies in GAD, 1xbet 모바일 as an adjunctive therapy in MDD.

Ulotaront is being jointly developed 1xbet 모바일 commercialized as part of a collaboration between Sumitomo Pharma, its U.S. subsidiary Sumitomo Pharma America, Inc. (SMPA), 1xbet 모바일 Otsuka.

SMPA discovered ulotaront 1xbet 모바일 collaboration with PsychoGenics based 1xbet 모바일 part on a mechanism-1xbet 모바일dependent approach us1xbet 모바일g the 1xbet 모바일 vivo phenotypic SmartCube^®platform 1xbet 모바일 associated artificial intelligence algorithms.

About Trace Am1xbet 모바일e-Associated Receptor 1 (TAAR1)

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

About Schizophrenia

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

Source: