- July 10, 2018
- Posted by: PharmaScroll
Anavex Life Sciences, a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental diseases, announced that the Company has received approval from the Spanish Agency for Medicinal Products and Medical Devices (AEMPS), to initiate its Phase 2, double-blind, placebo-controlled 14-week trial of the safety and efficacy of ANAVEX®2-73 for the treatment of Parkinson’s disease dementia (PDD). The Phase 2 study is scheduled to initiate enrollment of approximately 120 patients, randomized 1:1:1 to two different ANAVEX®2-73 doses or placebo, within the next few months, in up to 24 clinical study sites.
Also the company announced that it has received approval by the Australian Human Research Ethics Committee to initiate its Phase 2b/3 double-blind, randomized, placebo-controlled, 48-week safety and efficacy trial of ANAVEX®2-73 for the treatment of early Alzheimer’s disease. The Phase 2b/3 study is scheduled to initiate enrollment of approximately 450 patients, randomized 1:1:1 to two different ANAVEX®2-73 doses or placebo within the next month. As part of the planned international study, North American sites will be added.
The Company ‘s trial design for the Phase 2 program in PDD includes genomic, precision medicine-based biomarkers identified from patients previously treated with ANAVEX®2-73. This novel approach has informed clinical trial designs and is expected to yield insight as to potential responders, and to enrich future regulatory submissions.
Professor Dag Aarsland, MD, Head of Department of Old Age Psychiatry at the Institute of Psychiatry, Psychology and Neuroscience at King’s College London commented: “Since as many as 80 percent of people with Parkinson’s will experience Parkinson’s disease dementia and treatment options are limited, this study is using the latest generation of diagnostic and treatment developments in Parkinson’s disease dementia and I am looking forward to a potential contribution to the future development of this significant unmet need.”
In Alzheimer’s Disease, the ANAVEX®2-73 Phase 2b/3 study design includes genomic precision medicine biomarkers identified in the ANAVEX®2-73 Phase 2a study. Primary and secondary endpoints will assess safety and both cognitive and functional efficacy, measured through ADAS-Cog, ADCS-ADL and CDR-SB. ANAVEX®2-73 Phase 2a Alzheimer’s disease study previously demonstrated dose dependent improvement in exploratory endpoints of cognition (MMSE) and function (ADCS-ADL).
“We are extremely pleased to gain approval to initiate the ANAVEX®2-73 Phase 2b/3 study for the treatment of early Alzheimer’s disease, an area of very high unmet need for the growing number of patients around the world,” said Christopher U Missling, PhD, President and Chief Executive Officer of Anavex.
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To read more news about Alzheimer’s disease indication, visit https://pharmascroll.com/news-category/alzheimers/
News Source: Avanex Lifesciences Website
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