January 7, 5:00 p.m. EST

Transcription

1 Study Phase 2 Trial: Preliminary Results BIOD-531, a Concentrated Ultra-Rapid-Acting Prandial/Basal Insulin, Demonstrates Superior Post-Meal Glucose Control Compared to Marketed Prandial/Basal Insulins in Patients with Diabetes Who Require High Doses of Insulin January 7, 5:00 p.m. EST

2 Phase 2 Meal Study Trial Design 12 Diabetes patients requiring >150 units of insulin daily or >100 units of insulin per dose Single center, single blind, randomized four period crossover BIOD-531 (531) before meal (pre-meal) BIOD-531 (531) 20 minutes after beginning of meal (post-meal) to test ultra-rapid-acting onset of action Humulin R U-500 (U-500) before meal (pre-meal) Humalog Mix 75/25 (75/25) before meal (pre-meal) injected subcutaneously in conjunction with breakfast (1.2 U/kg) and dinner (0.8 U/kg) Glucose measured every 5 minutes throughout the day; insulin measured periodically Subjects receive standardized lunches and bedtime snacks with no insulin Injection site toleration assessed using 100 mm Visual Analog Scales and severity scores Visit 1-2 (screening) Visit 3 (1st dosing visit) Visit 4 (2nd dosing visit) Visit 5 (3rd dosing visit) Visit 6 (4th dosing visit) Visit 7 (final visit) 531 (pre-meal) 531 (pre-meal) 531 (pre-meal) 531 (pre-meal) 2-21 days 75/25 (pre-meal) 75/25 (pre-meal) 75/25 (pre-meal) 75/25 (pre-meal) 2-14 days 531 (post-meal) 531 (post-meal) 531 (post-meal) 531 (post-meal) U-500 (pre-meal) U-500 (pre-meal) U-500 (pre-meal) U-500 (pre-meal) 6-21 days wash-out period 6-21 days wash-out period 6-21 days wash-out period January 7,

3 Study 3-151: Mean Glucose Responses to Pre-Meal BIOD-531 vs. Pre-Meal Humalog Mix 75/ BIOD-531 pre-meal Humalog Mix 75/25 pre-meal 200 Blood Glucose (mg/dl) Minutes Standard Breakfast) Standard Lunch Standard Dinner) Bedtime Snack January 7,

4 Study 3-151: Mean Glucose Responses to Pre-Meal or Post-Meal BIOD-531 vs. Pre-Meal Humalog Mix 75/ BIOD-531 pre-meal Humalog Mix 75/25 pre-meal BIOD-531 post-meal Blood Glucose (mg/dl) Minutes Standard Breakfast) Standard Lunch Standard Dinner) Bedtime Snack January 7,

5 Study 3-151: Mean Glucose Responses to Pre-Meal or Post-Meal BIOD- 531 vs. Pre-Meal Humalog Mix 75/25 and Pre-Meal Humulin R U BIOD-531 pre-meal Humalog Mix 75/25 pre-meal BIOD-531 post-meal Humulin R U-500 pre-meal Blood Glucose (mg/dl) Minutes Standard Breakfast) Standard Lunch Standard Dinner) Bedtime Snack January 7,

6 Average Glucose Concentrations: BIOD-531 vs. Humalog Mix 75/25 vs. Humulin R U BIOD-531 pre-meal Humalog Mix75/25 pre-meal Average Glucose Concentrations (mg/dl) Primary Efficacy Endpoint * * ** Humulin R U-500 pre-meal BIOD-531 post-meal ** 130 Breakfast Breakfast - Lunch Lunch Breakfast Breakfast - Dinner Dinner Overall Overall Test Test Period Period * p<0.05 Vs. pre-meal BIOD-531 comparison ** p<0.05 Vs. pre-meal and post-meal BIOD-531 comparison January 7,

7 80 75 Percentage of Glucose Values Between mg/dl Target Range: BIOD-531 vs. Humalog Mix75/25 vs. Humulin R U-500 BIOD-531 pre-meal Humalog Mix75/25 pre-meal Humulin R U-500 pre-meal BIOD-531 post-meal * * ** Breakfast - Lunch Breakfast - Dinner Overall Test Period * p<0.05 Vs. pre-meal BIOD-531 comparison ** p<0.05 Vs. post-meal BIOD-531 comparison + p<0.05 Vs, pre- and post-meal BIOD-531 comparisons January 7,

8 Study Phase 2 Trial: Preliminary Results January 7, 5:00 p.m. EST

9 BIOD-531: Ultra-Rapid-Acting Prandial Insulin with Suitable Duration of Action/Basal Profile and Reduced Volume of Injection Insulin Product Desired Attribute for Treatment of Diabetes Patients Prandial Coverage Post-Meal Dosing Basal Coverage Reduced Volume of Injection BIOD-531 (U-400) Humulin R U-500 X X Pre-mixed Insulins* X X X BIOD-531 demonstrates superior glucose control compared to marketed prandial/basal insulins Percentage of readings within the target range is higher for BIOD-531 than comparators BIOD-531 dosed after meals is at least as effective as comparators dosed before meals BIOD-531 basal activity is at least as effective as comparators supporting similar dosing frequencies Mean visual analog scores and absolute severity scores were low for all treatment groups, suggesting excellent injection site tolerability * Preparations of human insulin or rapid acting analog prandial insulins such as Humalog and NovoLog premixed with intermediate-acting neutral protamine insulins in a variety of ratios such as 70/30, 75/25 and 50/50 January 7,

10 BIOD-531 Late Stage Clinical Development Plans: Phase 3 Designed With Recent Written FDA Feedback Phase 2b: Study : Randomized, parallel group study in patients with Type 2 diabetes, BIOD-531 vs. Humalog Mix 75/25, n= week (6 weeks titration, 3-months stable dosing) treatment period Primary endpoint = HbA1c non-inferiority Secondary endpoints include postprandial glycemia, hypoglycemia and weight. To be initiated in 2Q2015; top line data projected for mid 2016 Phase 3 Study 3-350: Patients with Type 1 diabetes, BIOD-531 vs. Comparator (to be determined), n=500 Study 3-351: Patients with Type 2 diabetes, BIOD-531 vs. Humalog Mix 75/25, n=500 Study & Study 3-351: 24 week (3 month titration followed by 3 months stable dosing) treatment period Primary endpoint: HbA1c non-inferiority To be extended for additional 6 months of dosing for safety database Final pivotal trial designs to be confirmed with FDA prior to initiation Toxicology and CMC studies in support of pivotal Phase 3 studies to be initiated in 2015 Ready for pivotal trials in 2016 January 7,

11 Study Phase 2 Trial: Preliminary Results BIOD-531, a Concentrated Ultra-Rapid-Acting Prandial/Basal Insulin, Demonstrates Superior Post-Meal Glucose Control Compared to Marketed Prandial/Basal Insulins in Patients with Diabetes Who Require High Doses of Insulin January 7, 5:00 p.m. EST