Anavex Provides Corporate Update, Announces Completion of Clinical Conduct of ADME and DDI Clinical Studies
Key Highlights
- ➤DDI study completed with 65 participants receiving 30 mg blarcamesine; full analysis ongoing
- ➤ADME study completed with 8 participants receiving 30 mg blarcamesine; full analysis ongoing
- ➤FDA cleared Anavex’s Fragile X syndrome IND; study start-up activities underway
- ➤FDA meeting scheduled for November to discuss adding pediatric participants to Phase 3 Rett study
- ➤Blarcamesine clinical pharmacology studies expected to support Alzheimer’s, Rett and Fragile X programs
Expert Statements
Terrie Kellmeyer, Interim Chief Executive Officer of Anavex Life Sciences Corp.
“Completion of the DDI and ADME studies represents an important milestone for blarcamesine, advancing the clinical pharmacology data package recommended by the FDA, which we expect to benefit our ongoing core programs.”
Terrie Kellmeyer, Interim Chief Executive Officer of Anavex Life Sciences Corp.
“Together with the FDA’s recent clearance of our IND in Fragile X syndrome, these studies reflect positive progress and execution on timelines previously set forth. With these achievements, we believe that we are well positioned to continue to move forward on our strategic objectives through the remainder of the year.”
NEW YORK, Oct. 20, 2026 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. (“Anavex” or the “Company”), a clinical-stage biopharmaceutical company developing innovative treatments for central nervous system diseases with significant unmet medical needs, today provided a corporate update highlighting progress across its three core indications for blarcamesine (ANAVEX 2-73): early Alzheimer’s disease, Rett syndrome and Fragile X syndrome. Recent Company highlights include the completion of clinical conduct of the Drug-drug Interaction (DDI) and Absorption, Distribution, Metabolism and Excretion (ADME) studies of blarcamesine, clearance by the U.S. Food and Drug Administration (FDA) of the Company’s Investigational New Drug (IND) application in Fragile X syndrome, and an upcoming meeting with the FDA in November to discuss adding pediatric participants to the Phase 3 Rett syndrome study.
“Completion of the DDI and ADME studies represents an important milestone for blarcamesine, advancing the clinical pharmacology data package recommended by the FDA, which we expect to benefit our ongoing core programs.” said Terrie Kellmeyer, Ph.D., Interim Chief Executive Officer. “Together with the FDA’s recent clearance of our IND in Fragile X syndrome, these studies reflect positive progress and execution on timelines previously set forth. With these achievements, we believe that we are well positioned to continue to move forward on our strategic objectives through the remainder of the year.”
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