Slide 1: ORA-D-007 Presentation of Results
ORA - D - 007 : Randomized, Double - Blind, Placebo - Controlled Study to Assess the Safety and Efficacy of Multiple Oral Bedtime Doses of ORMD - 0801 (Insulin Capsules) in Adult Patients with Type 2 Diabetes Mellitus who are Inadequately Controlled with Diet and Metformin Presentation of Results Ju
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 m
Slide 3: Study Objectives
Primary Objectives • To evaluate the pharmacodynamics effects of ORMD - 0801 on mean nighttime glucose (determined using continuous glucose monitoring (CGM)). • To evaluate the safety of ORMD - 0801, including incidence of hypoglycemia. Secondary Objectives • To evaluate changes from baseline in fas
Slide 4: Study Disposition Summary
Study Disposition Summary Number of Subjects in Safety Population (Received Treatment) Placebo – 64 Subjects ORMD - 0801 460IU – 61 Subjects ORMD - 0801 690IU – 63 Subjects Overall – 188 Subjects Number of Subjects Discontinuing Study Placebo – 2 Subjects (3.1%) ORMD - 0801 460IU – 4 Subjects (6.6%)
Slide 5: Summary of Demographics
Summary of Demographics Placebo (N=64) ORMD - 0801 460IU (N=61) ORMD - 0801 690IU (N=63) Sex - n (%) Male 29 (45.3) 39 (63.9) 34 (54.0) Female 35 (54.7) 22 (36.1) 29 (46.0) 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
Slide 6: Primary Efficacy Objective
Primary Efficacy Objective p - value = 0.0268* p - value = 0.0117* 6
Slide 7: Other Continuous Glucose Monitoring Parameters (Exploratory Objectives)
Other Continuous Glucose Monitoring Parameters (Exploratory Objectives) p - value = <0.0001* p - value = <0.0001* p - value = 0.0010* 7
Slide 8: HbA1c (Exploratory Objective)
HbA1c (Exploratory Objective) p - value = 0.0149* 8
Slide 9: Safety Summary
Safety Summary Placebo (N=64) ORMD - 0801 460IU (N=61) ORMD - 0801 690IU (N=63) Number of Reported Adverse Events: 34 34 42 Number (%) of Subjects With at Least One: Treatment Emergent Adverse Event (TEAE) 19 (29.7) 19 (31.1) 19 (30.2) Severe TEAE 0 ( 0.0) 1 ( 1.6) 0 ( 0.0) Serious TEAE 0 ( 0.0) 1 (
Slide 10: Thank You
THANK YOU www.oramed.com