Slide 1: Oramed Clinical Conference Call
Oramed Clinical Conference Call Monday, November 3, 2014 - 10:00 a.m. Eastern Time
Slide 2: Safe Harbor
Safe Harbor Certain statements contained in this material are forward-looking statements. These forward-looking statements are based on the current expectations of the management of Oramed only, and are subject to a number of factors and uncertainties that could cause actual results to differ materi
Slide 3: Oramed ORA-D-010 study design
Oramed ORA-D-010 A Prospective, Randomized, Double-blind, Placebo Controlled Study to Assess the Impact of ORMD-0801 (insulin capsules) on the Exogenous Insulin Requirements of Type 1 Diabetics 25 Subject (24 Planned, 25 Enrolled) 3 Day Placebo Run-in Period (Baseline) followed by 7 Days of Treatmen
Slide 4: All subjects completed the study
All 25 subjects completed the study. Demographics The active treatment group had proportionally less females (20% vs. 50%) The active treatment group had proportionally less Hispanics / Latinos (6.7% vs. 40%) Ages are similar between treatment groups (37.6 (Placebo) vs. 38.9 (Active)) All subjects t
Slide 5: Basal Exogenous Insulin - ITT - All Subjects
Basal Exogenous Insulin - ITT - All Subjects Placebo Run-in Period Average- 50.15 IU Day 6 and 7 Average - 49.05 IU Change → -1.10 IU Active Treatment Run-in Period Average - 37.67 IU Day 6 and 7 Average - 35.75 IU Change → -1.92 IU
Slide 6: Bolus Exogenous Insulin - ITT - All Subjects
Bolus Exogenous Insulin - ITT - All Subjects Placebo Run-in Period Average- 37.20 IU Day 6 and 7 Average - 41.13 IU Change → 3.93 IU Active Treatment Run-in Period Average -30.11 IU Day 6 and 7 Average - 29.93 IU Change → -0.18 IU
Slide 7: Total Exogenous Insulin - ITT - All Subjects
Total Exogenous Insulin - ITT - All Subjects Placebo Run-in Period Average- 87.34 IU Day 6 and 7 Average - 90.17 IU Change → 2.83 IU Active Treatment Run-in Period Average - 67.78 IU Day 6 and 7 Average - 65.68 IU Change → -2.09 IU
Slide 8: Continuous Glucose Monitoring
Continuous Glucose Monitoring Nighttime Glucose Placebo Run-in Period Combined - 161.73 Last 2 Days With At Least 80% of Readings - 133.17 Change → -28.56 Active Treatment Run-in Period Combined - 158.77 Last 2 Days With At Least 80% of Readings - 137.65 Change → -21.12 Daytime Glucose Placebo Run-i
Slide 9: Day Change from Average Run-in Value
Day 1 Change from Average Run-in Value Placebo → -27.3 Active → -29.7 Day 2 Change from Average Run-in Value Placebo → -31.8 Active → -43.5 Day 3 Change from Average Run-in Value Placebo → -35.9 Active → -52.0 Day 4 Change from Average Run-in Value Placebo → -37.6 Active → -59.5 Day 5 Change from Av
Slide 10: Hypoglycemic Events
Day 6 Placebo No events - 5 (50.0%) 1 event - 3 (30.0%) 2 events - 2 (20.0%) Active No events - 1 (6.7%) 1 event - 7 (46.7%) 2 events - 2 (13.3%) 3 events - 4 (26.7%) 5 events - 1 (6.7%) Day 7 Placebo No events - 4 (40.0%) 1 event - 4 (40.0%) 2 events - 1 (10.0%) 7 events - 1 (10.0%) Active No event
Slide 11: Thank You
THANK YOU