Oramed Pharmaceuticals Inc. · NASDAQ:ORMP

Oramed Pharmaceuticals — EASD 2020

14 slides from Oramed Pharmaceuticals's conference presentation, 2020

  1. Slide 1: Evening Oral Insulin (ORMD-0801) Glycemic Effects in Uncontrolled T2DM Patients

    Evening Oral Insulin (ORMD-0801) Glycemic Effects in Uncontrolled T2DM Patients Roy Eldor1, Alexander Fleming2, Joel Neutel3, Kenneth Homer4, Miriam Kidron5, Julio Rosenstock6 1Institute of Endocrinology, Metabolism & Hypertension, Tel-Aviv Sourasky Medical Center; 2Kinexum LLC, Harpers Ferry, WV, U

  2. Slide 2: Financial Disclosure

    FINANCIAL DISCLOSURE Presenter: Roy Eldor Oramed Pharmaceuticals: Medical consultant Alexander Fleming Oramed Pharmaceuticals: Scientific advisory board member Joel Neutel Integrium: Clinical Research Organization for this study Kenneth Homer Integrium: Clinical Research Organization for this study

  3. Slide 3: Fate of Protein/Peptides in the GIT

    FATE OF PROTEIN/PEPTIDES IN THE GIT Harsh pH Mechanical Protease Absorption challenges threat barrier Protein breakdown, low bioavailability

  4. Slide 4: Oramed Technology: Making needles needless

    ORAMED TECHNOLOGY Making needles needless Protease inhibitors Enteric coating Emulsifier PROTEIN/ PEPTIDE Absorption enhancer

  5. Slide 5: Insulin Route

    INSULIN ROUTE Sytemic circulation  Portal/peripheral FPM ratios are retained ➔  lower risk of hypoglycemia 20% of secreted insulin reaches the bloodstream

  6. Slide 6: Background/Objective

    BACKGROUND/OBJECTIVE Systemically administered insulin is associated with risk of hypoglycemia and weight gain. ORAL Portally infused insulin brings to a more rapid and pronounced suppression of hepatic glucose production, reduced fasting blood glucose concentrations and to reduced circulating INSUL

  7. Slide 7: Study Design

    STUDY DESIGN DOSE ESCALATION FOLLOW UP SCREENING ONLY FOR PATIENTS RANDOMIZED QD 2 wks after TO RECEIVE 32 mg ORMD-0801: At bedtime last dose Double-blind, 2 weeks, with dose escalation from 16 mg to 24 mg ORMD-0801 or placebo, QD, BID or BID TID at bedtime and 30-45 min before breakfast SCR RUN DOS

  8. Slide 8: Demographics and Baseline Characteristics

    DEMOGRAPHICS AND BASELINE CHARACTERISTICS QD BID TID POOLED 8 mg 16 mg 32 mg 8 mg 16 mg 32 mg 32 mg PLACEBO N=15 N=18 N=69 N=17 N=15 N=68 N=69 N=82 Sex, n (%) 49 (59.8) 10 (66.7) 11 (61.1) 42 (60.9) 10 (58.8) 11 (73.3) 45 (66.2) 40 (58.0) Male 33 (40.2) 5 (33.3) 7 (38.9) 27 (39.1 7 (41.2) 4 (26.7) 2

  9. Slide 9: Results – HbA1c Change from Baseline – ITT Population

    RESULTS – HBA1C CHANGE FROM BASELINE – INTENT TO TREAT (ITT) POPULATION PL QD BID TID 0.2 0 p=0.49 8 mg 16 mg 32 mg 8 mg 16 mg 32 mg 32 mg -0.2 -0.4 p=0.36 p=0.09 -0.6 p=0.04 p=0.04 -0.8 p=0.03 p=0.03 -1 * Least square means are presented. **The number of subjects at baseline and at 12-weeks differ.

  10. Slide 10: Results – Weeks 10-12 Continuous Glucose Area Under the Curve

    RESULTS – WEEKS 10-12 CONTINUOUS GLUCOSE AREA UNDER THE CURVE (MG*H/DL) - ITT PL QD BID TID PL QD BID TID PL QD BID TID 8 mg 16 mg 32 mg 8 mg 16 mg 32 mg 32 mg 8 mg 16 mg 32 mg 8 mg 16 mg 32 mg 32 mg 8 mg 16 mg 32 mg 8 mg 16 mg 32 mg 32 mg 200 195.6 137.8 150 Change from run-in AUC 100 37.6 50 24.1

  11. Slide 11: Results – Body Weight (kg)

    RESULTS – BODY WEIGHT (KG) PLACEBO QD BID TID 8 mg 16 mg 32 mg 8 mg 16 mg 32 mg 32 mg Baseline 95.7±5.3 109.3±6.5 95.4±6.6 96.3±5.1 100.9±6.4 96.7±6.5 94.0±4.9 97.2±5.1 Week 12 92.8±5.5 110.3±6.9 97.0±6.9 95.8±5.3 99.7±6.9 92.5±7.3 92.8±5.0 96.6±5.2 Change from -0.3±0.8 -1.4±1.0 0.5±1.0 0.1±0.8 -0.6

  12. Slide 12: Safety – Hypoglycemia

    SAFETY - HYPOGLYCEMIA 25 events, 5 patients 16 events, 4 patients PL 8BID 25 mild 15 mild, 1 moderate HYPOGLYCEMIA# HYPOGLYCEMIA 0 events 0 events 8QD 16BID 20 events, 1 patient 4 events, 3 patients 16QD 32BID 20 mild 4 mild 16 events, 6 patients 32 events, 6 patients 32QD 32TID 15 mild, 1 moderate

  13. Slide 13: Safety – Drug-Related Adverse Events (DRAEs)

    SAFETY –DRUG-RELATED ADVERSE EVENTS* (DRAES) 8 mg 16 mg 32 mg 8 mg 16 mg 32 mg 32 mg PL QD QD QD BID BID BID TID 3 patients 2 patients 0 patients 6 patients 0 patients 1 patient 3 patients 9 patients Hypoglycemia, Abdominal Diarrhea, Headache, Intermittent Diarrhea, DRAE* papules on cramping, headac

  14. Slide 14: Conclusion and Discussion

    CONCLUSION AND DISCUSSION The 12-week 8-32 mg ORMD-0801 QD and BID treatments elicited clinically significant HbA1c reductions among T2DM patients inadequately controlled on standard therapies and with mean HbA1c levels >8%. CGM and serum glucose measures showed similar trends. ORMD-0801 was not ass

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