BIOD-531: Preliminary Phase IIa data

Preliminary data from the single-blind, 4-way crossover, U.S. Phase IIa Study 3-151 in 12 Type I and II diabetics with severe insulin resistance showed that subcutaneous BIOD-531 given immediately before breakfast was superior to Humalog Mix 75/25 insulin lispro protamine/insulin lispro on the primary endpoint of improving average glucose concentration from 0 to 330 minutes post-breakfast (164.6 vs. 179.9 mg/dL, p=0.009). BIOD-531 given immediately before breakfast was also superior to Humalog R U-500 insulin on the primary endpoint (164.6 vs. 178 mg/dL, p=0.019).

Pre-meal BIOD-531 also significantly increased the percentage of glucose readings within the target range of 70-180 mg/dL during the 330 minute post-breakfast period vs. Humalog Mix 75/25 (65.3% vs. 49%, p=0.004) and Humalog R (65.3% vs. 51.2%, p=0.009). Additionally, pre-meal BIOD-531 significantly improved average glucose concentration (165 vs. 184.9 mg/dL, p=0.007) and the percentage of glucose readings within the target range (67% vs. 49%, p=0.011) over the 660 minute period after breakfast until dinner vs. Humalog Mix 75/25. BIOD-531 given 20 minutes after the start of breakfast and dinner significantly improved mean glucose concentrations over the 24-hour period vs. pre-meal Humalog Mix 75/25 (149.8 vs. 172.6 mg/dL, p=0.006). ...