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Posted On: 10/13/2021 11:49:24 AM
Post# of 1460
News: "AVXL today announced that the Independent Data Safety Monitoring Board (DSMB) for the Company's Phase 2b/3 Alzheimer’s disease study of its investigational compound ANAVEX®2-73 (blarcamesine) has completed its recent pre-planned review of the preliminary Phase 2b/3 study data.
As specified in the protocol, the DSMB reviewed the interim safety data for the ANAVEX®2-73 Phase 2b/3 Alzheimer’s disease clinical study ANAVEX®2-73-AD-004 and its Open Label Extension (OLE) ANAVEX®2-73-AD-EP-004 ATTENTION-AD study.
Upon review of the interim safety data, the DSMB made the following recommendation:
The DSMB recommendation is to continue the studies without modification.
DSMBs are committees commonly used in clinical trials to protect the interests of the patients and the integrity of the study data in ongoing trials.
ANAVEX®2-73 activates the sigma-1 receptor (SIGMAR1). Data suggests that activation of SIGMAR1 results in the restoration of complete housekeeping function within the body and is pivotal to restoring neural cell homeostasis and promoting neuroplasticity.1
PET scan data previously confirmed dose-dependent target engagement of SIGMAR1 with ANAVEX®2-73.2
The placebo-controlled 509-patient Phase 2b/3 ANAVEX®2-73 clinical study in patients with Alzheimer's disease achieved full enrollment and includes prespecified SIGMAR1 gene expression as endpoints using ADAS-Cog (cognition) and ADCS-ADL (activities of daily living and function) as primary endpoints.3 The Company anticipates topline data in the second half of 2022."
As specified in the protocol, the DSMB reviewed the interim safety data for the ANAVEX®2-73 Phase 2b/3 Alzheimer’s disease clinical study ANAVEX®2-73-AD-004 and its Open Label Extension (OLE) ANAVEX®2-73-AD-EP-004 ATTENTION-AD study.
Upon review of the interim safety data, the DSMB made the following recommendation:
The DSMB recommendation is to continue the studies without modification.
DSMBs are committees commonly used in clinical trials to protect the interests of the patients and the integrity of the study data in ongoing trials.
ANAVEX®2-73 activates the sigma-1 receptor (SIGMAR1). Data suggests that activation of SIGMAR1 results in the restoration of complete housekeeping function within the body and is pivotal to restoring neural cell homeostasis and promoting neuroplasticity.1
PET scan data previously confirmed dose-dependent target engagement of SIGMAR1 with ANAVEX®2-73.2
The placebo-controlled 509-patient Phase 2b/3 ANAVEX®2-73 clinical study in patients with Alzheimer's disease achieved full enrollment and includes prespecified SIGMAR1 gene expression as endpoints using ADAS-Cog (cognition) and ADCS-ADL (activities of daily living and function) as primary endpoints.3 The Company anticipates topline data in the second half of 2022."
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