"The formulation of the drug was changed between the Phase 2 and Phase 3 studies. Unfortunately, this change in formulation had the unintended consequence of lowering drug levels in patients. We are confident that our newly developed formulation will provide increased exposure and allow a more conclusive test of drug efficacy," said Samuel Henderson, PhD, Vice President of Research & Development at Accera.
"We are pleased that analysis of the data has provided support for the treatment hypothesis and valuable information for the future development of the program," said Michael Gold, MD, Accera's Senior Medical Advisor. "We are grateful for the time and effort of the patients, caregivers and investigators who participated in this study. Accera remains committed to its work in Alzheimer's disease with the goal of developing an effective drug for patients. We are now finalizing our clinical development plan and will engage with the FDA to confirm our proposed path forward."
Accera intends to present the full results and analysis of this Phase 3 study at the Alzheimer's Association International Conference in London in July 2017.
About the NOURISH AD Phase 3 Clinical Study
NOURISH AD is a 26-week, double-blind, randomized, placebo-controlled, parallel-group study investigating the effects of daily administration of AC-1204 in subjects with mild to moderate Alzheimer's disease, with an optional 26-week open-label extension. The primary and key secondary endpoints will examine the effects of AC-1204 on memory and cognition as measured by the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-Cog) and global function as measured by the Alzheimer's Disease Study Cooperative Study – Clinical Global Impression of Change (ADCS-CGIC) after 26 weeks among non-carriers of the epsilon 4 variant of the gene apolipoprotein E (APOE4). The study will also evaluate activities of daily living, resource utilization and quality of life among subjects with mild-to-moderate Alzheimer's.
Accera, Inc. is a CNS therapeutics company based in Boulder, Colorado. The company's proprietary scientific platform addresses unmet medical needs in brain health, including Alzheimer's disease. Accera is focused on the clinical development of drugs with innovative mechanisms of actions. The company's management team includes globally recognized specialists in central nervous system diseases and drug development, who together leverage the latest scientific knowledge and understanding of neurological disorders. Accera's lead candidate is AC-1204, a small molecule drug compound in a Phase 3 clinical study in patients with mild to moderate Alzheimer's disease. For more information, visit www.accerapharma.com.
Follow Accera on Twitter at twitter.com/accerainc.
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SOURCE Accera, Inc.