GR-MD-02 in Liver Fibrosis

NASH with advanced fibrosis clinical development program

Phase 1 Clinical Trial GT-020
• Title: Phase 1 Study to Evaluate Safety of GR-MD-02 in Subjects With Non-Alcoholic Steatohepatitis (NASH) and Advanced Fibrosis
• Status: Completed December 2014
• More information on trial design can be found at clinicaltrials.gov: https://clinicaltrials.gov/ct2/show/NCT01899859?term=GR-MD-02&rank=2
• Results: Description of results can be found in CEO Perspective

Phase 1 Clinical Trial GT-029
• Title: A Single Center, Open-Label, Phase 1 Drug-Drug Interaction Study to Evaluate the Pharmacokinetics of Midazolam following Single and Multiple Doses of GR MD 02 in Normal Healthy Volunteer Subjects
• Status: Completed May 2015
• Results: Description of results can be found in CEO Perspective

Phase 2 Clinical Trial GT-026: NASH-CX
• Title: Clinical Trial to Evaluate the Safety and Efficacy of GR-MD-02 for the Treatment of Liver Fibrosis and Resultant Portal Hypertension in Patients With Nash Cirrhosis (NASH-CX)
• Status: Enrolling
• More information on trial design can be found at clinicaltrials.gov: https://clinicaltrials.gov/ct2/show/NCT02462967?term=GR-MD-02&rank=3 and in CEO Perspective

Phase 2 Clinical Trial GT-026: NASH-FX
• Title: Clinical Study for Non-Invasive Imaging Methods for GR-MD-02 for Treatment of Liver Fibrosis (NASH-FX)
• Status: Enrolling
• More information on trial design can be found at clinicaltrials.gov: https://clinicaltrials.gov/ct2/show/NCT02421094?term=GR-MD-02&rank=4 and in CEO Perspective