Danish pharmaceutical manufacturer Lingbei launches Lu AF35700 Phase III clinical project for new schizophrenia
March 15, 2016 Source: Bio Valley
Window._bd_share_config={ "common":{ "bdSnsKey":{ },"bdText":"","bdMini":"2","bdMiniList":false,"bdPic":"","bdStyle":" 0","bdSize":"16"},"share":{ }};with(document)0[(getElementsByTagName('head')[0]||body).appendChild(createElement('script')) .src='http://bdimg.share.baidu.com/static/api/js/share.js?v=89860593.js?cdnversion='+~(-new Date()/36e5)];March 15, 2016 / Bio Valley BIOON / -- Danish pharmaceutical company Lundbeck recently announced the launch of a phase III clinical trial of the new antipsychotic drug Lu AF35700. The project consists of two key Phase III studies that will evaluate the efficacy and safety of two doses of Lu AF35700 (10 mg, 20 mg) in the treatment of refractory schizophrenia (TRS). The primary end point was the change in the total score of the 10th week Positive and Negative Symptoms Scale (PANSS) from baseline, and the other endpoints included the clinical overall impression - Severity of Disease (CGI-S) score, Personal and Social Function Scale (PSP). .
The first key Phase III study plans to recruit approximately 1,000 patients in approximately 15 countries, including the United States and Canada. The study is expected to last for about three years. The entire project will involve more than 2,000 patients.
In the United States, the FDA has granted Lu AF35700 a fast-track status for the treatment of refractory schizophrenia (TRS), which is expected to be the first new pharmacological therapy in the refractory schizophrenia (TRS) population in the past few decades. . Currently, only one drug (clozapine, Clozapine) is approved for the treatment of refractory schizophrenia, but the drug is not well tolerated and needs regular testing. Its application is severely limited due to some serious safety issues. .
Lu AF35700 has a novel pharmacological mechanism. Compared with D2 dopamine receptor, Lu AF35700 has a dominant advantage in the occupancy of D1 dopamine receptors, and has a high proportion of 5-HT2A and 5-HT6 serotonin receptors. Bit.
Given the relatively low occupancy of Lu AF35700 for D1 dopamine receptors, the drug is expected to reduce the burden of adverse events such as EPS, elevated prolactin, irritability, loss of pleasure or anhedonia, and depression. In the completed safety clinical study, Lu AF35700 is generally well tolerated with favorable safety.
Schizophrenia is a chronic, severe mental health disorder that is often disabling. It is estimated that about 30% of patients with schizophrenia have no relief from pharmacological treatment and are considered to be refractory to schizophrenia. These patients account for a significant proportion of schizophrenia-related health care expenditures, including the use of hospitalization and other health resources.
Clozapine is the only drug that has been shown to be effective in the treatment of refractory schizophrenia (TRS), but patients are generally poorly tolerated and require regular testing due to the drug and some serious The security issue is related, so its application is severely limited.
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