2019-0107 AXSM +161.22% 51,352,047 6.87 29,813,168
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Posted On: 01/19/2019 1:49:19 PM
2019-0107 AXSM +161.22% 51,352,047 6.87 29,813,168
January 7, 2019 6:00 AM
Axsome Therapeutics Announces AXS-05 Achieves Primary Endpoint in Phase 2 Trial in Major Depressive Disorder
Demonstrated statistically significant improvement in MADRS scores compared to active comparator (p<0.001 on primary endpoint)
Rapid improvement in depressive symptoms demonstrating statistically significant superiority over active comparator within the first week (p=0.045 on CGI-I)
Improvement with AXS-05 versus active comparator seen on multiple secondary endpoints, including remission in 47% of AXS-05 patients versus 16% of active comparator patients (p=0.004)
Data support ongoing development of AXS-05 in treatment resistant depression and further development in MDD
Potentially first-in-class, oral NMDA receptor antagonist with multimodal activity for the treatment of depression
Company to host conference call at 8:30 AM ET
NEW YORK, Jan. 07, 2019 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a clinical-stage biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, today announced that AXS-05, a novel, oral, investigational NMDA receptor antagonist with multimodal activity, met the prespecified primary endpoint and significantly improved symptoms of depression in the ASCEND Phase 2 trial in major depressive disorder (MDD). The ASCEND study is a randomized, double-blind, active-controlled, multi-center, U.S. trial, in which 80 adult patients with confirmed moderate to severe MDD were treated either with AXS-05 (45 mg dextromethorphan/105 mg bupropion), or the active comparator bupropion (105 mg), twice daily for 6 weeks.
AXS-05 met the prespecified primary endpoint by demonstrating a highly statistically significant reduction in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score, averaged over the 6-week treatment period (overall treatment effect), as compared to bupropion (p<0.001). At Week 6, AXS-05 demonstrated a 17.2 point reduction in the MADRS total score compared to a 12.1 point reduction for bupropion (p=0.013). AXS-05 rapidly reduced depressive symptoms, demonstrating a statistically significant improvement over bupropion on the Clinical Global Impression-Improvement scale (CGI-I) at Week 1 (p=0.045). Starting at Week 1, AXS-05 achieved numerical superiority over bupropion on the MADRS total score, with statistical significance achieved at Week 2 and maintained at all time points thereafter. At Week 6, 47% of patients who received AXS-05 achieved remission, prospectively defined as a score of 10 or less on the MADRS, compared with 16% of patients who received bupropion (p=0.004).
AXS-05 was superior to bupropion on multiple prespecified secondary endpoints, with statistically significant effects demonstrated on most, including the following: MADRS-6 (p=0.007 at Week 6); percentage of responders on MADRS-6 (response defined as ≥ 50% reduction from baseline) (p=0.014 at Week 6); CGI-I (p=0.045 at Week 1, and 0.051 at Week 6); Clinical Global Impression-Severity scale (CGI-S) (p=0.028 at Week 6); percentage of patients achieving remission on MADRS (remission defined as MADRS ≤10) (p=0.004 at Week 6). Additionally, the treatment effect observed with bupropion in the study was consistent with that observed in prior published trials.
“The clinically meaningful improvements in depressive symptoms seen with AXS-05 in this study were achieved versus an active comparator that is a well-established antidepressant, as early as only one week after initiation of treatment,” said Professor Maurizio Fava, MD, Executive Vice Chair, Department of Psychiatry, Massachusetts General Hospital (MGH) and Associate Dean for Clinical & Translational Research, Harvard Medical School. “Data show currently marketed antidepressants fail to provide adequate treatment response in about two thirds of treated patients. An estimated 16 million Americans suffer from major depressive disorder each year. As an oral NMDA receptor antagonist with multimodal activity, AXS-05 could provide a new approach to treating this potentially life-threatening condition.”
Fifty-one percent (51%) of patients in the trial had experienced three or more major depressive episodes prior to enrollment. Twenty-three percent (23%) of study participants had received first line treatment in their current major depressive episode prior to treatment with study medication.
AXS-05 was safe and well tolerated with no serious adverse events. The most commonly reported adverse events in the AXS-05 arm
January 7, 2019 6:00 AM
Axsome Therapeutics Announces AXS-05 Achieves Primary Endpoint in Phase 2 Trial in Major Depressive Disorder
Demonstrated statistically significant improvement in MADRS scores compared to active comparator (p<0.001 on primary endpoint)
Rapid improvement in depressive symptoms demonstrating statistically significant superiority over active comparator within the first week (p=0.045 on CGI-I)
Improvement with AXS-05 versus active comparator seen on multiple secondary endpoints, including remission in 47% of AXS-05 patients versus 16% of active comparator patients (p=0.004)
Data support ongoing development of AXS-05 in treatment resistant depression and further development in MDD
Potentially first-in-class, oral NMDA receptor antagonist with multimodal activity for the treatment of depression
Company to host conference call at 8:30 AM ET
NEW YORK, Jan. 07, 2019 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a clinical-stage biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, today announced that AXS-05, a novel, oral, investigational NMDA receptor antagonist with multimodal activity, met the prespecified primary endpoint and significantly improved symptoms of depression in the ASCEND Phase 2 trial in major depressive disorder (MDD). The ASCEND study is a randomized, double-blind, active-controlled, multi-center, U.S. trial, in which 80 adult patients with confirmed moderate to severe MDD were treated either with AXS-05 (45 mg dextromethorphan/105 mg bupropion), or the active comparator bupropion (105 mg), twice daily for 6 weeks.
AXS-05 met the prespecified primary endpoint by demonstrating a highly statistically significant reduction in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score, averaged over the 6-week treatment period (overall treatment effect), as compared to bupropion (p<0.001). At Week 6, AXS-05 demonstrated a 17.2 point reduction in the MADRS total score compared to a 12.1 point reduction for bupropion (p=0.013). AXS-05 rapidly reduced depressive symptoms, demonstrating a statistically significant improvement over bupropion on the Clinical Global Impression-Improvement scale (CGI-I) at Week 1 (p=0.045). Starting at Week 1, AXS-05 achieved numerical superiority over bupropion on the MADRS total score, with statistical significance achieved at Week 2 and maintained at all time points thereafter. At Week 6, 47% of patients who received AXS-05 achieved remission, prospectively defined as a score of 10 or less on the MADRS, compared with 16% of patients who received bupropion (p=0.004).
AXS-05 was superior to bupropion on multiple prespecified secondary endpoints, with statistically significant effects demonstrated on most, including the following: MADRS-6 (p=0.007 at Week 6); percentage of responders on MADRS-6 (response defined as ≥ 50% reduction from baseline) (p=0.014 at Week 6); CGI-I (p=0.045 at Week 1, and 0.051 at Week 6); Clinical Global Impression-Severity scale (CGI-S) (p=0.028 at Week 6); percentage of patients achieving remission on MADRS (remission defined as MADRS ≤10) (p=0.004 at Week 6). Additionally, the treatment effect observed with bupropion in the study was consistent with that observed in prior published trials.
“The clinically meaningful improvements in depressive symptoms seen with AXS-05 in this study were achieved versus an active comparator that is a well-established antidepressant, as early as only one week after initiation of treatment,” said Professor Maurizio Fava, MD, Executive Vice Chair, Department of Psychiatry, Massachusetts General Hospital (MGH) and Associate Dean for Clinical & Translational Research, Harvard Medical School. “Data show currently marketed antidepressants fail to provide adequate treatment response in about two thirds of treated patients. An estimated 16 million Americans suffer from major depressive disorder each year. As an oral NMDA receptor antagonist with multimodal activity, AXS-05 could provide a new approach to treating this potentially life-threatening condition.”
Fifty-one percent (51%) of patients in the trial had experienced three or more major depressive episodes prior to enrollment. Twenty-three percent (23%) of study participants had received first line treatment in their current major depressive episode prior to treatment with study medication.
AXS-05 was safe and well tolerated with no serious adverse events. The most commonly reported adverse events in the AXS-05 arm
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I (Znewcar1) do not provide personal investment advice and I am not a qualified licensed investment advisor. I am an amateur investor.
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