Clinically meaningful, dose-dependent, and statistically significant improvements in the Cognitive Drug Research (CDR) computerized assessment system analysis
Company to host conference call today at 8:30 AM ET
NEW YORK, Oct. 15, 2020 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. (“Anavex” or the “Company”) (NASDAQ:AVXL), a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental disorders including Alzheimer’s disease (AD), Parkinson’s disease (PD), Rett syndrome and other central nervous system (CNS) diseases, today announced results from the proof of concept Phase 2 controlled trial evaluating the safety, tolerability, and efficacy of ANAVEX®2-73 (blarcamesine) in patients with Parkinson’s disease dementia (PDD).
The study found that ANAVEX®2-73 (blarcamesine) was safe and well tolerated in oral doses up to 50 mg once daily. The results show clinically meaningful, dose-dependent, and statistically significant improvements in the Cognitive Drug Research (CDR) computerized assessment system analysis. The study confirmed the precision medicine approach of targeting SIGMAR1 as a genetic biomarker of response to ANAVEX®2-73 (blarcamesine).
The ANAVEX®2-73-PDD-001 study was an international, double-blind, multicenter, placebo-controlled Phase 2 clinical study and randomized 132 patients with PDD equally to target doses of 30mg, 50mg ANAVEX®2-73 (blarcamesine) or placebo, respectively. In addition to safety and cognitive efficacy, sleep function was assessed during the study at week 8 and week 14.
ANAVEX®2-73-PDD-001 study results will be submitted for presentation at a medical conference and for publication in a peer-reviewed medical journal. Anavex is planning a pivotal trial of ANAVEX®2-73 (blarcamesine) in Parkinson’s disease dementia after submitting the results of the study to the FDA to obtain regulatory guidance.
Dr. Jaime Kulisevsky Bojarski, MD, PhD, Full Professor of Neurology & Vice-Dean Faculty of Medicine Autonomous University of Barcelona and Director of the Movement Disorders Unit, Department of Neurology, Sant Pau Hospital and Principal Investigator in the trial, commented, "As the first double-blind trial of ANAVEX®2-73 (blarcamesine) in PDD, this proof-of-concept study provides extremely encouraging data. PDD can be debilitating with significant co-morbidities. New therapies are urgently needed to alleviate this suffering and disability. There has not been a mechanistically novel medication approved for PDD in over 20 years."
“I am very pleased to see the promising results of the ANAVEX®2-73-PDD-001 trial, providing significant improvements in cognitive function accompanied by a favorable safety and tolerability profile,” said Dag Aarsland, MD, PhD, Professor and the Head of Department of Old Age Psychiatry at the Institute of Psychiatry, Psychology & Neuroscience, King’s College London, UK. “Cognitive impairment of patients with Parkinson’s disease dementia is very distressing to patients and their families and is associated with greater risk of institutionalization and accelerated progression to severe dementia and death. Given the limited options of adequate treatments for Parkinson’s disease dementia, and the safety concerns and modest or uncertain efficacy of currently used off-label treatments, the ANAVEX®2-73 (blarcamesine) study results represent a meaningful step forward toward urgently needed treatment for this serious complication of Parkinson’s disease.”
“We would like to thank all the patients and participating families as well the investigators and clinical site coordinators for their dedication to this stud,” said Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex. "Our strategy to advance ANAVEX®2-73 (blarcamesine) with focus on Precision Medicine has been validated in this study of patients with significant cognitive impairment and we are looking forward to the next clinical data readout of ANAVEX®2-73 (blarcamesine) in Rett syndrome and Alzheimer’s disease, indications where cognitive impairment is also prevalent.”
After completing the trial, participants were able to enroll in a voluntary 48-week open-label extension study, ANAVEX®2-73-PDD-EP-001, which continues to assess safety, long term efficacy and changes in gut microbiota.1
ANAVEX®2-73 (blarcamesine) is an orally available, small-molecule activator of the sigma-1 receptor, which has been shown to be pivotal to restoring neural cell homeostasis and promoting neuroplasticity.2