Accera Announces Results of its First Phase 3 Study in Mild-to-Moderate Alzheimer's Disease
February 28, 2017
-Bioavailability of the drug was suboptimal-
-New drug formulation addressing bioavailability has been developed and Accera is now finalizing next steps-
BOULDER, Colo., Feb. 28, 2017 — Accera, Inc., a leading CNS therapeutics company, today announced results of the AC-1204 Phase 3 study for the treatment of mild-to-moderate Alzheimer's disease. Patients treated with AC-1204 did not demonstrate a statistically significant difference at 26 weeks compared with patients treated with placebo, as measured by the Alzheimer's disease Assessment Scale-Cognitive Subscale test (ADAS-Cog). In the study, AC-1204 was shown to be safe and demonstrated high levels of tolerability with the most prevalent adverse event being only mild, transient gastrointestinal disturbance. A detailed pharmacokinetic analysis has shown that the modified AC-1204 formulation used in the study resulted in lower drug plasma levels than prior formulations. This suboptimal exposure contributed to the lack of efficacy observed in the trial.
Charles Stacey, MD, the company's President and Chief Executive Officer commented, "The trial result is disappointing for us and the millions of patients, caregivers and physicians who urgently need new treatment options for this devastating disease. This outcome is unexpected in light of the data seen in our Phase 2 study in which patients exhibited a statistically significant improvement of greater than 3 points in ADAS-Cog."
"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.