| AICURE ANNOUNCES NEW STUDY RESULTS DEMONSTRATING AVERAGE ADHERENCE RATES OF 96.7% IN PATIENTS POST HOSPITAL DISCHARGE |
| Data Presented Today at CNS Summit Reinforces Value of AiCure in Increasing Adherence and Retention Based on Results from Phase 2 Takeda Study New York, Oct. 27, 2016 — AiCure, a clinically-validated artificial intelligence company that visually confirms medication ingestion on smartphones, announced that study results presented today during the CNS Summit confirm that use of the AiCure Platform can significantly increases medication adherence and study retention in patients with schizophrenia. A recent Phase 2 study (NCT02477020) was completed in the United States, evaluating the efficacy, safety, and tolerability of treatment for 6 weeks with TAK-063 compared with placebo in subjects with acutely exacerbated schizophrenia. TAK-063 is a potent and selective inhibitor of PDE10A in development for the treatment of schizophrenia. Study subjects were in-hospital for the first 3 weeks of the study and eligible to be discharged after that. Clinically stable subjects were discharged to the outpatient portion of the study and followed using the AiCure application on a mobile device for the remainder of the 6-week treatment period. Results: Mean cumulative adherence rates based on visual confirmation of drug ingestion (AI Platform) were 82.5% from Week 4 or Week 5 (depending on when subjects were discharged) through Week 6. The majority of these subjects (“high adherers”) had rates of adherence above 80%, with average adherence rates of 96.7%. Subject completion rates were 80.8% in the outpatient segment among subjects using the AiCure Platform compared to 64.6% for the entire trial (inpatient and outpatient). Pill counts and pharmacokinetic samples do not provide a continuous measurement of adherence. In addition, pill counts can be falsified and plasma and urine assays are subject to individual differences in metabolism. As a result, neither method offers a full and accurate adherence profile for each subject over time. Adherence monitoring is problematic in trials where even brief interruptions in medication usage, or partial adherence, can drown out an efficacy signal and lead a trial to fail. Average adherence in patients with schizophrenia is 50%. “Following an acute exacerbation of schizophrenia, the majority of subjects were able to use the technology throughout the outpatient portion of the study and maintain optimal adherence. This study demonstrates the feasibility of using AI platforms as a potential tool to monitor adherence in real-time including in patients recently discharged from the hospital who are highly vulnerable to treatment discontinuation and relapse, both in clinical research and population health settings”, said Adam Hanina, CEO of AiCure. |