AiCure announces new study results demonstrating 90% adherence from Phase 2 Abbvie study
|AICURE ANNOUNCES NEW STUDY RESULTS DEMONSTRATING 90% ADHERENCE IN PATIENTS WITH SCHIZOPHRENIA USING AICURE PLATFORM BASED ON DRUG CONCENTRATION LEVELS|
Data Presented Today at ISCTM Validating the AiCure Platform based on Phase 2 Abbvie study
New York, Sept. 26, 2016 — AiCure, a clinically-validated artificial intelligence company that visually confirms medication ingestion on smartphones, announced that study results presented today during the International Society for CNS Clinical Trials and Methodology (ISCTM) Scientific Sessions confirm that use of the AiCure Platform significantly increases medication adherence in patients with schizophrenia, as measured by drug concentration levels.
The sub-study was part of a larger Abbvie, Phase 2, multicenter, randomized, double-blind, placebo-controlled, dose-ranging, parallel-group, study in nonsmoking subjects with schizophrenia who were clinically stable. Subjects were enrolled and randomized to placebo or ABT-126. Subjects were dosed once daily (QD) 25, 50, or 75mg ABT-126 or matching placebo, as 3 capsules in the morning for 24 weeks. The AiCure platform was introduced into 10 of 31 US sites; subjects were monitored either by AiCure or by modified Directly Observed Therapy (mDOT) at least 3 times per week. In addition, adherence was measured by review of returned study drug blister and scheduled pharmacokinetic sampling.
Results: cumulative adherence, measured by study drug concentrations above the LLOQ (minimum required therapeutic level), were higher through 24 weeks for subjects monitored using the AiCure platform (89.7%) compared with subjects monitored using mDOT (71.9%).
Traditional measures of adherence such as pill counts and other self-reported data are subject to patient tampering; deceptively removing pills to feign higher adherence leads to the high rates of adherence typically measured by pill count. Adherence according to pill count in this study ranged between 97% and 100%, consistent with most trials and evidence of the disparity between the two measures.
“The ability to increase adherence to 90% in challenging patient populations over 6 months is a powerful demonstration of the value of the platform in clinical research and clinical practice. Typical adherence in patients with schizophrenia is 50%”, said Adam Hanina, CEO of AiCure. “This research adds to the growing body of scientific evidence showing the advantages of using artificial intelligence to increase statistical power and reduce sample size in clinical trials, thereby decreasing costs and accelerating drug development. Utilizing AiCure’s proprietary platform, the accurate and clinically actionable data are setting a new gold standard in clinical research and clinical practice.”