Oramed Pharmaceuticals Inc. · NASDAQ:ORMP
Oramed Pharmaceuticals — Technical Presentation (June 2022)
22 slides from Oramed Pharmaceuticals's technical presentation, June 2022
Slide 1: Efficacy and safety of ORMD-0801 (Insulin Capsules) in patients with type 2 diabetes
Efficacy and safety of ORMD-0801(Insulin Capsules) in patients with type 2 diabetes mellitus inadequately controlled with metformin over 28 days: a randomized, double-blind, placebo-controlled study. (ORA-D-007) Roy Eldor 1, Joel Neutel 2, Ken Homer3, Miriam Kidron 4 1 Diabetes Unit, Institute for E
Slide 2: Disclosures
Disclosures ▪ The study was conducted by ORAMED Inc., Jerusalem, Israel. ▪ Financial support was provided by ORAMED Inc., Jerusalem, Israel. ▪ R. Eldor is a member of ORAMED’s scientific advisory board. ▪ M. Kidron is an employee and shareholder of ORAMED Inc., Jerusalem, Israel.
Slide 3: An Unsolved Challenge: Proteins and Peptides do Not Survive the Digestive System
An Unsolved Challenge: Proteins and Peptides do Not Survive the Digestive System Harsh pH Stomach acidity cleaves and shreds protein Protease attack Proteases attack and break down proteins Absorption barrier Most therapeutic proteins fail to be absorbed via the intestinal wall (barrier) 3
Slide 4: Oramed Technology Protects Drug Integrity and Increases Absorption
Oramed Technology Protects Drug Integrity and Increases Absorption pH shield for passage through stomach pH sensitive enteric coating protects capsule contents. Capsule dissolves only once in small intestine Protease protection Protease inhibitors stave off and protect the active agent from protease
Slide 5: ORA-D-007 Study rationale
ORA-D-007 Study rationale ▪ ORMD-0801 is an oral formulation of recombinant human insulin based on ORAMED’s Protein Oral Deliver Technology 5
Slide 6: In a previous Phase IIa study ORMD-0801 was Safe With no Serious Adverse Events
In a previous Phase Iia study ORMD-0801 was Safe With no Serious Adverse Events ▪ 30 T2DM patients ▪ Primary objective: Safety and tolerability ▪ Secondary objective: Pharmacodynamic effects on mean nighttime glucose Fasting CGM Glucose (mg/dL) Nighttime CGM Glucose (mg/dL) Daytime CGM Glucose (mg/d
Slide 7: ORA-D-007 Study rationale
ORA-D-007 Study rationale ▪ ORMD-0801 is an oral formulation of recombinant human insulin based on ORAMED’s Protein Oral Deliver Technology ▪ Here we report the results from a Phase 2b placebo controlled study, aimed to assess the safety and efficacy of the addition of ORMD-0801 (16 mg insulin or 24
Slide 8: Completed: 180 Patient FDA Phase IIb Study
Completed: 180 Patient FDA Phase IIb Study 33 US sites 180 patients 28 day treatment 1 time a day at night 8
Slide 9: ORA-D-007 Study diagram
ORA-D-007 Study diagram ORMD-0801 24mg (690IU) n=60 A1C 6.5 - 10% on metformin ≥ 1500mg/day for ≥ 2 R ORMD-0801 16mg (460IU) n=60 weeks Placebo n=60 14 to 28 day run-in period Day -7 Day 0 Day 21 Day 28 14 Day CGM CGM follow up • CGM- continuous glucose monitoring 9
Slide 10: Inclusion/Exclusion criteria
Inclusion/Exclusion criteria ▪ Inclusion - Adult patients with T2DM age 20-75 years, BMI 25-40kg/m2, who were on stable treatment with metformin (≥1500 mg/day) for at least 2 weeks and had HbA1c 6.5 - 10% at the screening visit ▪ naïve with HbA1c ≥7.5were started on or titrated to ≥1,500 mg metformi
Slide 11: ORA-D-007 Study: ORMD-0801 Endpoints and Objectives
ORA-D-007 Study: ORMD-0801 Endpoints and Objectives ▪ Safety of ORMD-0801 Primary ▪ Evaluate PD effects of ORMD-0801 (pooled 01 objectives doses) on mean night glucose (6 hours after treatment) ▪ Evaluate PD effects of ORMD-0801 (pooled doses) Secondary on fasting blood glucose, morning blood insuli
Slide 12: Baseline characteristics
Baseline characteristics Placebo (N=64) ORMD-0801 16 mg ORMD-0801 24 (N=61) mg (N=63) Age (Mean ± SD) 58.6±9.2 57.9±8.0 57.3±8.8 Men, n (%) 29 (45.3) 39 (63.9) 34 (54.0) Race, n (%) White 53 (82.8) 50 (82.0) 55 (87.3) Black or African American 7 (10.9) 8 (13.1) 4 (6.3) Asian 2 (3.1) 2 (3.3) 2 (3.2)
Slide 13: Primary Endpoint: Change from run-in nighttime CGM glucose
Primary Endpoint Safe and well tolerated oral delivery – No drug related serious adverse events Nighttime CGM Glucose Nighttime CGM Glucose Nighttime CGM Glucose Mean % change Mean mg/dl change Median mg/dl change Placebo 13.70 Placebo Placebo 12.38 Change from run-in – 80% trim 8.48 ORMD-0801 2.01*
Slide 14: Primary objective - Waterfall plot
Primary objective - Waterfall plot Placebo 460IU 690IU Placebo 460IU 690IU Change from baseline values as obtained from continuous glucose monitoring at 4 weeks - 80% trimmed data - ITT population. Efficacy assessments using CGM data were based on the results from the two last days during the assess
Slide 15: Other Continuous Glucose Monitoring Parameters (Exploratory Objectives)
Other Continuous Glucose Monitoring Parameters (Exploratory Objectives) Fasting Daytime 24 Hours 5AM to 7AM 6AM to 10PM Change from Run-in Period Glucose (mg/dl) Placebo P-value=<0.0001* 15.95 Placebo P-value=<0.0001* Placebo 13.26 P-value=0.0010* 11.88 ORMD-0801 P-value=0.0010* ORMD-0801 ORMD-0801
Slide 16: HbA1c (Exploratory Objective)
HbA1c (Exploratory Objective) Day 29 Change from baseline Placebo 0.20 ORMD-0801 -0.01* * Indicates comparison to placebo p-Value<0.05 16
Slide 17: Baseline values and treatment outcomes at 4 weeks - ITT population
Baseline values and treatment outcomes at 4 weeks - ITT population Placebo (N=58) ORMD-0801 ORMD-0801 24 ORMD-0801 16mg (N=54) mg (N=60) Combined (N=114) Morning fasting serum insulin (pmol/L) N 58 52 60 112 Day 29- End of treatment mean ± SD 125.5 ± 82.3 114.4 ± 75.7 114.9 ± 72.9 114.7 ± 73.9 Chang
Slide 18: Baseline values and treatment outcomes at 4 weeks - ITT population
Baseline values and treatment outcomes at 4 weeks - ITT population Placebo (N=58) ORMD-0801 ORMD-0801 24 ORMD-0801 16mg (N=54) mg (N=60) Combined (N=114) Alkaline Phosphatase (U/L), mean +SD N 62 59 63 Day 29- End of treatment mean ± SD 83.5 ± 24.8 89.6 ± 26.7 82.7 ± 22.6 Change, mean ± SD -4.9 ± 13
Slide 19: Overview of Treatment-Emergent Adverse Events by Treatment Group
Overview of Non-Hyperglycemic/Hypoglycemic Treatment- Emergent Adverse Events by Treatment Group- Safety Population Placebo ORMD-0801 ORMD-0801 N=64 460 IU 690 IU N (%) N= 61 N= 63 N (%) N (%) Total Adverse Events 34 34 42 TEAEs 19 (29.7) 19 (31.1) 19 (30.2) Severe TEAE 0 (0) 1 (1.6) 0 (0) Serious T
Slide 20: Conclusions: ORA-D-007 Study Demonstrated Safety and Blood Glucose Lowering Efficacy
Conclusions: ORA-D-007 Study Clearly Demonstrated the Safety and Blood Glucose Lowering Efficacy of ORMD-0801 Safe and well tolerated with no Sustained and significant glucose reduction significant hyperglycemic event observed in every CGM parameter: Fasting, Daytime, Nighttime, 24 hr HbA1c showed a
Slide 21: ORMD-0801 – ORA-D-007 results support the potential MOA - Liver directed insulin
ORMD-0801 – ORA-D-007 results support the potential MOA- Liver directed insulin ▪ Prolonged anti-hyperglycemic effect despite an expected short half life of regular insulin once absorbed into the blood stream. ▪ Lack of increase in hypoglycemia. ▪ Lack of increase in peripheral insulin. ▪ Lack of we
Slide 22: Acknowledgments
Acknowledgments ▪ The authors wish to thank the patients, investigators, and staff of the ORA-D-007 trial
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