Clinical Evidence

67%

Increase in Drug Concentration Levels

in stroke patients on DOACs
post-discharge1

90%

Mean Cumulative Pharmacokinetic Adherence

over 24 weeks across indications2

100%

Treatment Completion Rates

in patients with hepatitis C and tuberculosis3

Central Nervous System

AiCure is ensuring trial success in global CNS studies, Phases I-IV. Sponsors benefit from behavior and novel assessment tracking across thousands of patients and hundreds of sites.

AbbVie: JMIR; ISCTM. AiCure significantly increases drug exposure

AiCure helped AbbVie ensure high adherence to the investigational product (IP) in a Phase 2, 6-month schizophrenia study. Average adherence in schizophrenia trials can be as low as 61%. Subjects using AiCure achieved 89% mean adherence.

Bain EE, Shafner L, Walling DP, Othman AA, Chuang-Stein C, Hinkle J, Hanina A. Use of a Novel Artificial Intelligence Platform on Mobile Devices to Assess Dosing Compliance in a Phase 2 Clinical Trial in Subjects With Schizophrenia. JMIR Mhealth Uhealth. 2017 Feb 21;5(2):e18.

Presented at the International Society for CNS Clinical Trials and Methodology (ISCTM) Autumn 2016 Conference, September 26-27, 2016, Philadelphia, PA, USA.

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Roche: ASCP. AiCure used as the primary measure of adherence.

Subjects with schizophrenia treated with antipsychotics in a 15-week Phase 1b cross-over study achieved 94.9% mean adherence.

Presented during the American Society of Clinical Psychopharmacology (ASCP) Annual Meeting, May 29 – June 2, 2017, Miami Beach, FL, USA. Study BP29904: NCT02824055.

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Takeda: ASCP; CNS Summit. AiCure data helped researchers identify discrepancies in self-reported data at the point of PK sampling.

Subjects with an acute exacerbation of schizophrenia successfully used AiCure in a Phase 2 clinical study.

Presented during the American Society of Clinical Psychopharmacology (ASCP) Annual Meeting, May 29 – June 2, 2017, Miami Beach, FL, USA. Study 2002: NCT02477020.

Presented during the CNS Summit, October 27-30, 2016, Boca Raton, FL, USA. Study 2002: NCT02477020.

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Infectious Disease and Cardiovascular Disease

Montefiore Medical Center – Randomized controlled trial. Patients discharged following ischemic stroke used AiCure for 12 weeks.

Patients using AiCure had 100% of their plasma samples within therapeutic range vs 50% in the control group.

Labovitz DL, Shafner L, Reyes Gil M, Virmani D, Hanina A. Using Artificial Intelligence to Reduce the Risk of Nonadherence in Patients on Anticoagulation Therapy. Stroke. 2017 May;48(5):1416-1419

Presented during the Connected Health Symposium, October 20-21, 2016, Boston, MA. Study NCT02599259.

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Hepatitis C: AASLD. AiCure ensured optimal adherence in real-world setting.

Patients used AiCure to monitor adherence to fixed-dose ledipasvir and sofosbuvir. Mean cumulative dose adherence was 91.3% and treatment completion was 100% in a challenging patient population (100% reported current or past drug use).

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Tuberculosis: Vancouver; World Health Organization, Geneva. The Los Angeles County Department of Public Health (DPH) is using AiCure in lieu of in-person DOT to monitor adherence to therapy for TB disease and latent TB infection in ambulatory patients (outside the clinic).

Patients are achieving 94% mean adherence. Accurate monitoring using AiCure reduces patient and clinic burden, reducing the need for travel time and appointments. Expanding treatment access and monitoring to the 13 million LTBI patients is a key priority of the CDC. AiCure is working towards this common goal!

Presented during the 21st Conference of The Union North America Region, 22-25 February, 2017.

Presented at the “Digital health for the End TB Strategy: progress since 2015 and future perspectives”

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Clinical Trial Methodology and Statistical Analysis Implications

Accounting for subject nonadherence and eliminating inappropriate subjects in clinical trials are critical elements of a successful study.

Nonadherence can increase variance, lower study power, and reduce the magnitude of treatment effects.

Shiovitz TM, Bain EE, McCann DJ, Skolnick P, Laughren T, Hanina A, Burch D. Mitigating the Effects of Nonadherence in Clinical Trials. J Clin Pharmacol. 2016 Sep;56(9):1151-64.

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AiCure quantifies the benefit of monitoring patient behavior and demonstrates the impact on statistical power.

In clinical research, increasing adherence will result in an increase in drug concentration, which in turn will lead to a better efficacy outcome if a positive exposure-response relationship exists. Similarly, an increase in adherence will lead to better health outcomes in real-world settings.

Chuang-Stein, C; Hinkle J; Hanina A; Shafner L. The Impact of Adherence. April 2016

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