Alzheimer's (AD) is a breakthrough drug! AXS-05 (right methafin/aphetamine release agent) enters Phase 3 clinical!

December 31, 2020 // -- Axsome Therapeutics is a biopharmaceutical company dedicated to the development of innovative therapies for the treatment of central nervous system (CNS) diseases.
recently, the company announced the launch of the ACCORD (Assessment of Clinical Outcomes of Alzheimer's Disease) study, a randomized, double-blind, placebo-controlled Phase 3 study that will evaluate the efficacy and safety of AXS-05 (right methafin/aphetamine release agent) for the treatment of Alzheimer's disease (AD).
currently, no drug has been approved for the treatment of AD-thyre.
AXS-05 is a new type of oral NMDA body antagonist with multi-mode activity.
from the II/III ADVANCE-1 study, AXS-05 can quickly, substantially, and significantly improve the progression of AD patients compared to placebos.
June, the FDA granted AXS-05 the breakthrough drug qualification (BTD) for the treatment of AD.T.
this is also the second time the AXS-05 has been awarded BTD by the FDA.
, the FDA has granted AXS-05 BTD for the treatment of severe depression (MDD), as well as fast-track eligibility (FTD) for the treatment of refracingable depression (TRD) and AD.
. Herriot Tabuteau, Chief Executive Officer of
Axsome, said, "The launch of the Alzheimer's Phase 3 ACCORD trial continues to accelerate the clinical development of AXS-05 for the treatment of this serious disease.
AXS-05 has unique pharmacological characteristics, and its potential in this adaptation is supported by the positive results of the key ADVANCE trials we have completed.
Alzheimer's disease is a common and debilitating disease associated with the early placement of nursing homes to accelerate the development of severe dementia and an increased risk of death.
no drugs have been approved to treat Alzheimer's disease.
, the AXS-05 has the potential to address this highly unseoled need and significantly improve the lives of patients and their caregivers.
" Alzheimer's disease -AD (pictured: tecake.in) Alzheimer's disease (AD) is the most common type of dementia characterized by cognitive decline, behavioral and psychological symptoms including restlessness.
can be observed in 70 percent of AD patients, which is associated with accelerated cognitive decline, early placement in nursing homes, and increased mortality.
AXS-05 is a new, oral, proprietary NMDA subject antagonist with multi-mode activity and is currently being clinically developed to treat depression and other central nervous system (CNS) diseases.
AXS-05 consists of proprietary formulations and dosages of dextromethorphan and bupropion, and uses Axsome's metabolic suppression technology.
AXS-05's right methafin group is a non-competitive N-methyl-D-winter antagonist, also known as a glutamate-like regulator, which is a new mechanism of action that means it functions differently from most depression drugs currently available.
the right methafin part of AXS-05 is also a sigma-1 subjector astigtor, niacin acetylcholine ligand antagonist, serotonin, and dethyrene transporter inhibitor.
AXS-05's amphetamine component improves the bio-utilization of right methafin, a dethyriphrine and dopamine reuptake inhibitor and a niacin acetylcholine inhibitor antagonist.
AXS-05 holds more than 40 U.S. and international patents until 2034.
, AXS-05 has been shown to be effective in Alzheimer's, depression, and smoking cessation trials.
, AXS-05 showed rapid results in Both the Alzheimer's and depression control groups compared to both positive drugs and placebo control groups.
fda granted AXS-05 a breakthrough drug qualification (BTD) for the treatment of Alzheimer's disease, based on data from the Phase II/III ADVANCE-1 study.
this is a randomized, double-blind, controlled, multi-center, U.S. trial designed to evaluate the efficacy and safety of AXS-05 in treating AD aggressiveness.
in this study, 366 patients were randomly treated with AXS-05 (dose increased to 45 mg/105 mg twice daily), acetone (dose increased to 105 mg, 2 times daily), and placebo for 5 weeks of continuous treatment.
indicators of efficacy are the Cohen-Mansfield Emotional Behavior Scale (CMAI), or Koch Scale for short.
CMAI is a scale of 29 caregivers assessing the frequency of aggressive behavior in people with dementia, including excessive exercise (such as pacing), verbal attacks (such as screaming and shouting), and physical attacks (such as grabbing, pushing, and hitting).
the end of April, Axsome announced that the ADVANCE-1 trial had reached its main end point.
data showed that in week 5, the total CMAI score of patients in the AXS-05 group was statistically significantly lower than in the placebo group: the AXS-05 group decreased by an average of 15.4 points from the baseline and the placebo group by an average of 11.5 points (p-0.010).
results represent a decrease of 48 per cent for the AXS-05 group from the baseline level and 38 per cent for the placebo group.
AXS-05 also outperformed acetone (p<0.001) in cmAI overall, confirming the contribution of the right methadone component in the drug.
AXS-05 can quickly improve the symptoms of aggressiveness.
improvement in the total CMAI score of AXS-05 from week 2 was numerically superior to that of placebo, achieving statistically significant statistical significantness only one week after the full dose of AXS-05 was used, i.e. week 3 .007.
Compared to the placebo group, the proportion of patients in the AXS-05 group who received a clinical response to CMAI (73% vs. 57%, p-0.005) increased statistically, defined as a 30% or higher increase over the baseline level.
these results are consistent with overall assessment changes measured by clinicians using the improved Alzheimer's Collaborative Study-Clinical Change Overall Impression Scale (mADCS-CGIC).
AXS-05 showed a statistically significant improvement over placebo (p.036).
AXS-05 was well- resistant in this experiment.
the most common adverse reactions in the AXS-05 group were drowsiness (8.2 per cent in the AXS-05 group, 4.1 per cent in the admoetone group and 3.2 per cent in the placebo group), dizziness (6.3 per cent, 10.2 per cent, 3.2 per cent) and diarrhoea (4.4 per cent, 6.1 per cent and 4.4 per cent, respectively).
in the AXS-05, acetone and placebo groups, the rates of drug suspension due to adverse events were 1.3%, 2.0% and 1.3%, respectively.
3.1 percent of patients treated with AXS-05 had severe adverse events, while 8.2 percent of patients treated with acetone and 5.7 percent were treated with a placebo, respectively.
no serious adverse events associated with the study drug were found in any of the treatment groups.
deaths in the placebo group, one death in the acetone group and none in the AXS-05 group.
small mental state examination (MMSE) is a widely used general cognitive function measurement method, there is no evidence of cognitive decline in patients treated with AXS-05.
AXS-05 treatment has nothing to do with sedation.
() Original source: Axsome Therapeutics Initiates ACCORD Phase 3 Trial of AXS-05 in Alzheimer's Disease Agitation<!--/ewebeditor:page->