Oramed Pharmaceuticals Inc. · NASDAQ:ORMP
Oramed Pharmaceuticals — GTC Diabetes Summit (April 2014)
21 slides from Oramed Pharmaceuticals's conference presentation, Apr 24, 2014
Slide 1: The tolerability and efficacy of oral insulin in Type 2 diabetes patients: A pilot clinical study
The tolerability and efficacy of oral insulin in Type 2 diabetes patients: A pilot clinical study GTC Diabetes Summit Dr. Miriam Kidron April 24, 2014
Slide 2: Oramed Background
Oramed Background
Slide 3: Oramed POD™ Technology: Absorption Enhancers
Oramed POD™ Technology: Absorption Enhancers Assists with translocation of active ingredient (protein/ peptides) across intestinal membrane into bloodstream Oramed’s delivery platform protects insulin and enhances its absorption , allowing it to reach the bloodstream via the portal vein, thereby est
Slide 4: Study ORA-D-009
Study ORA-D-009
Slide 5: Phase IIa, randomized, double-blind, placebo-controlled study
STUDY: Phase IIa, randomized, double-blind, placebo- controlled SETTING : In-patient (8 days) PARTICIPANTS : 30 male or female adult T2DM patients inadequately controlled with diet and metformin TREATMENT : 16 mg or 24 mg insulin, or placebo, at bedtime.
Slide 6: ORA-D-009 was a substudy requested by the FDA
ORA-D-009 was a substudy requested by the FDA prior to commencement of a large scale study with a similar design. The study was initiated to ensure safety of ORMD-0801 and was not powered to demonstrate efficacy.
Slide 7: Primary and secondary objectives
PRIMARY OBJECTIVE: • To evaluate the safety and tolerability of ORMD-0801 SECONDARY OBJECTIVES : • To evaluate the PD effect of ORMD-0801 on mean night time (10 PM - 6 AM) glucose (CGM data) as compared to placebo • To evaluate changes from baseline in fasting blood (finger stick) and plasma glucose
Slide 8: Dosing
Dosing ORMD-0801 was supplied as gel caps formulated as either 8 mg or 16 mg • First group received two 8 mg gel caps • Second dose group received one 8mg and one 16 mg gel cap Gel Cap Dissolution: Performance Issue with 16 mg gel caps During the course of the study, GMP analysis of study drug formu
Slide 9: Study Design
Study Design 14 days ORMD-0801 8mg + 8 mg ORMD-0801 8mg + 16 mg
Slide 10: Patient demographics
Patient demographics Placebo ORMD-0801 8 + 8mg ORMD-0801 8mg+16mg Sex, n (%) Male 3 (30.0) 5 (50.0) 7 (70.0) Female 7 (70.0) 5 (50.0) 3 (30.0) Race, n (%) White 6 (60.0) 6 (60.0) 6 (60.0) Black/African Am 4 (40.0) 2 (20.0) 1 (10.0) Asian 0 (0.0) 1 (10.0) 3 (30.0) N. Hawaiian/Pacific Is 0 (0.0) 1 (10
Slide 11: Results
Results
Slide 12: Primary objective - safety and tolerability
Primary objective - safety and tolerability No significant changes in clinical laboratory and physical parameters were noted Hypoglycemic Events Serious Adverse Events Severe Adverse Events ORMD 0801 Related Adverse Events Adverse Events (non treatment related): Placebo 5 patients 7 reported adverse
Slide 13: Mean night time glucose concentrations (CGM)
Night time mean (SD) CGM Glucose - mg/DL (1) Placebo (n = 10) ORMD 0801 8 mg + 8 mg (n = 10) Difference (ORMD 0801 - placebo) ORMD 0801 8 mg + 16 mg (n = 8) Difference (ORMD 0801 - placebo) Last 2 days of data 167.95 (64.172) 135.64 (39.400) -32.31 150.24 (49.264) -17.71 All 7 days 165.85 (60.760) 1
Slide 14: Mean daytime glucose concentrations (CGM)
Daytime mean (SD) CGM Glucose - mg/DL (1) Placebo (n = 10) ORMD 0801 8 mg + 8 mg (n = 10) Difference (ORMD 0801 - placebo) ORMD 0801 8 mg + 16 mg (n = 8) Difference (ORMD 0801 - placebo) Last 2 days of data 176.06 (63.698) 153.23 (40.160) -22.83 158.58 (40.672) -17.48 All 7 days 175.99 (61.115) 152.
Slide 15: Mean fasting glucose concentrations (CGM)
Fasted mean (SD) CGM Glucose - mg/DL (1) Placebo (n = 10) ORMD 0801 8 mg + 8 mg (n = 10) Difference (ORMD 0801 - placebo) ORMD 0801 8 mg + 16 mg (n = 8) Difference (ORMD 0801 - placebo) Last 2 days of data 156.26 (58.622) 126.02 (27.264) -30.24 136.12 (43.168) -20.14 All 7 days 154.37 (57.993) 129.2
Slide 16: Morning fasting serum insulin
Morning fasting serum insulin - μIU/mL (2) Placebo (n = 10) ORMD 0801 8 mg + 8 mg (n = 10) Difference (ORMD 0801 - placebo) ORMD 0801 8 mg + 16 mg (n = 10) Difference (ORMD 0801 - placebo) Screening 34.51 (64.375) 20.80 (18.984) -13.71 17.34 (12.225) -17.17 Day 2 9.01 (4.665) 11.93 (10.122) 2.92 12.
Slide 17: Morning fasting C-peptide
Morning fasting C-peptide - mg/DL (2) Placebo (n = 10) ORMD 0801 8 mg + 8 mg (n = 10) Difference (ORMD 0801 - placebo) ORMD 0801 8 mg + 16 mg (n = 10) Difference (ORMD 0801 - placebo) Screening 5.159 (4.9825) 4.233 (2.3869) -0.926 3.125 (1.3372) -2.134 Day 2 2.400 (0.9419) 3.180 (1.6593) 0.78 3.064
Slide 18: ORMD-0801: Phase IIa T2DM Conclusions
ORMD-0801: Phase IIa T2DM Conclusions Safety Conclusions • ORMD-0801 oral insulin gel caps were observed to be safe and well-tolerated for the dosing regimen considered in this study • No hypoglycemic events occurred at any point during the study in any treatment group • No ORMD 0801 related adverse
Slide 19: Planned Phase IIb trial
Planned Phase IIb trial ORA-D-007
Slide 20: ORMD-0801: Phase IIb T2DM
ORMD-0801: Phase IIb T2DM Study ORA-D-007: Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Pharmacodynamics of Multiple Oral Bedtime Doses of ORMD-0801 in Adult Patients with T2DM who are Inadequately Controlled with Diet and Metformin PRIMARY OBJECTIVE: • To evaluate the
Slide 21: Thank you!
Thank you! Dr. Miriam Kidron CSO, Oramed Pharmaceuticals miriam@oramed.com
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