Top-Line Data Expected in December 2016
BOULDER, Colo., May 12, 2016 – Accera, Inc. today announced that it has completed enrollment of the NOURISH AD Phase 3 clinical study of AC-1204 for the treatment of mild to moderate Alzheimer’s disease. The company expects to report top-line data in December.
In conjunction with this, Accera is finalizing plans for a second pivotal Phase 3 study that will be required for regulatory approval of the drug. Data from NOURISH AD will inform the design of this study, which Accera plans to initiate early next year.
“Accera is one of a few companies that will report Phase 3 clinical results in Alzheimer’s in 2016,” said Dr. Charles Stacey, the company’s president and CEO. “Positive Phase 3 data will provide further clinical validation of targeting the metabolic deficit that is known to be characteristic of Alzheimer’s disease. Furthermore, it will build on the impressive efficacy data we obtained in our Phase 2b study.”
Data from the Phase 2b study showed a significant improvement compared to placebo of greater than 3 points in the Alzheimer’s Disease Assessment Scale-Cognitive (ADAS-Cog) in patients with mild to moderate Alzheimer’s disease who did not carry the epsilon 4 variant of the apolipoprotein E gene (APOE4).
Dr. Stacey further commented, “Physicians need new treatment options; we believe that our drug candidate has the potential to become an integral part of the armamentarium for use in treating mild to moderate Alzheimer’s disease.”
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 clinical-stage biotechnology company based in Boulder, Colo., that is developing therapies for central nervous system disorders. 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 product candidate is AC-1204, a ketosis-inducing compound in a Phase 3 clinical study in patients with mild to moderate Alzheimer’s disease. For more information, visit www.accerapharma.com.