Quickly improve symptoms! AXS-05 Treatment AD-Related Mania II/III Clinical End point

On April 27, local time, Axsome Therapeutics announced that its NMDA receptor antagonist AXS-05 had reached its primary endpoint in the 2/3 clinical trial ADVANCE-1 for Alzheimer's disease (AD) patients: rapid and significant improvement slower symptoms of restlessness in AD patients compared to placebosADVANCE-1 is a randomized, double-blind, controlled, multicenter study designed to assess the efficacy and safety of AXS-05 for Patients with AD-related restlessnessThe study included 366 patients diagnosed with AD and clinically significant restlessness, arranged 1:1:1 random grouping to receive AXS-05 (right meschafin/amphetamine, the dose increased from 30 mg/105 mg 1 time per day to 45 mg/105 mg twice a day), or atanifyability (dose increased from 105 mg 1 to 2 times per day), or continued for 5 weeksThe group was then modified according to an independent data monitoring committee, and patients were randomly treated with AXS-05 or placebo at a 1:1 ratioThe main finish point was a change in the total score of the Cohen-Mansfield Mania Questionnaire (CMAI) in Week 5 compared to the baselineCMAI is a 29-question caregiver scale that measures the frequency of behavior associated with restlessness in people with dementia, including excessive movement, verbal attack, and physical assaultresults showed that the total CMAI scores of patients in the AXS-05 treatment group were statistically significantly lower than in the placebo group, reaching the primary endpointThe total score in the AXS-05 group was reduced by an average of 15.4 points, in the amphetamine group was 10.0 points (p0.001) and in the placebo group was 11.5 points (p.010), with a statistically significant decrease in the averageCompared to baseline levels, the average percentage of restlessness in the AXS-05 group was 48 percent lower and the placebo group was 38 percentAt the same time, AXS-05 was also superior to the amphetamine treatment group (p0.001) in CMAI total scoredthe trial also demonstrated that AXS-05 can rapidly improve symptoms of restlessnessStarting in Week 2, the improvement in CMAI total score in patients with AXS-05 was numerically superior to placeboThe AXS-05 group decreased by an average of 11.5 points and the placebo was 8.7 points (p-0.069)In week 3, the improvement was statistically significant, with a 13.8 score reduction in the AXS-05 group and a placebo group of 9.7 points (p-0.007)studies, AXS-05 was well toleratedThe most common adverse reactions were drowsiness (AXS-05 group: 8.2%, amphetamine group: 4.1%, placebo group: 3.2%), dizziness (6.3%, 10.2%, 3.2%) and diarrhea (4.4%, 6.1%, 4.4%, respectively)In the AXS-05, amphetamine and placebo groups, the rates of severe adverse events were 3.1%, 8.2% and 5.7%, respectively, and the rates of discontinuation of adverse events were 1.3%, 2.0% and 1.3%, respectively A small mental state examination showed no evidence of cognitive decline in patients treated with AXS-05 AD is a progressive neurodegenerative disease characterized by cognitive decline, behavioral and psychological symptoms including restlessness It is reported that 70% of AD patients develop restlessness symptoms There is currently no approved treatment for irritability in Patients with AD AXS-05 is an innovative oral NMDA receptor antagonist consisting of right meschafin and amphetamines Among them, right meschafin is a non-competitive NMDA receptor antagonist, but also glutamate receptor regulator, sigma-1 receptor agonists, 5-serotonin and norepinephrine transport inhibitors, niacin acetylcholine receptor antagonists and small glial activation inhibitors Amphetamine synotherons are norepinephrine and dopamine reuptake inhibitors, and pyridoxaecholine receptor antagonists, which increase the bioavailability of right meschafin Therefore, the drug has several neurotransmitter systems associated with AD cognitive and behavioral abnormalities , AXS-05 is currently being developed to treat AD restlessness, severe depressive disorder (MDD), refractory depression (TRD), smoking cessation and other central nervous system diseases Previously, AXS-05 has been awarded the FDA's title of breakthrough therapy for the treatment of MDD, as well as a quick track for the treatment of AD restlessness and drug-resistant depression "We are pleased to see the positive results of the ADVANCE-1 trial, which provides clear evidence for reducing AD restlessness," said Dr Jeffrey Cummings, a professor of brain science at the University of Nevada, Las Vegas, and emeritus director of the Luluvo Brain Health Center in Cleveland Clinically, a significant reduction in restlessness is accompanied by good safety and tolerability of medication Irritability occurs in most AD patients, is painful for patients and their families, and is associated with a greater risk of hospitalization and accelerated development into severe dementia and death The positive results of AXS-05 represent a meaningful step towards an urgent lying choice of treatment due to the lack of recognized treatments, the safety of the use of non-label edicts, and the uncertain efficacy "With the ADVANCE-1 trial, AXS-05 has proven its effectiveness in AD mania, depression, and smoking cessation trials," said Dr Cedric O'Gorman, Senior Vice President of Clinical Development and Medical Affairs, Axsome Axsome is committed to accelerating the delivery of innovative, effective and safe drugs for patients with inadequate selection of central nervous system therapies, and the company's late-stage product line includes five candidate products AXS-05, AXS-07, AXS-09, AXS-12 and AXS-14 for the development of 7 different indications Axsome in the pipeline Source: The Company's website Axsome CEO Dr Herriot Tabuteau, said he looks forward to discussing the data with the FDA and will submit an application for a new drug for the treatment of severe depression and another drug, AXS-07, in the fourth quarter of this year reference source: 1, Axsome's Drug for Alzheimer's In's Hits Primary Endpoints in Phase II/III Trial 2, AxTherapeutics AXS-05 Achieves Primary In ADVANCE-1 Pivotal Phase 2/3 Trial in's Disease