Biodel Inc. recently announced initial results from Study 3-201, a phase II study evaluating its diabetes candidate, BIOD-123.
BIOD-123, an ultra-rapid-acting mealtime insulin based on RHI formulation, is being developed for the treatment of type I diabetes.
In the randomized, open label, parallel group study, BIOD-123 was compared to Eli Lilly and Company’s (LLY - Free Report) Humalog with respect to various parameters such as measures of HbA1c, weight changes, postprandial glucose excursions, glycemic variability and hypoglycemic event rates.
The study was a randomized, open label, parallel group study conducted across approximately 32 U.S. sites. During the 18-week study, approximately 132 type I diabetes patients with HbA1c levels between 6.5% and 8.5% received either BIOD-123 or Humalog as meal-time insulin.
The study consisted of two phases - a 6-week dose titration phase and a 12-week relative stable dosing phase.
Each group consisted of 66 patients. Sanofi’s (SNY) Lantus (glargine), was used as the basal insulin in both arms. Female population in the BIOD-123 arm was 50.8% while it was 28.8% in the Humalog arm. Average HbA1c level was balanced between the two arms, with 7.36% and 7.33% in the BIOD-123 arm and the Humalog arm, respectively. The BIOD-123 arm patients had average diabetes duration of 25.8 years whereas it was 20.5 years in the Humalog arm.
BIOD-123 met the primary endpoint of non-inferiority in HbA1c control compared to Humalog. There was no statistically significant difference in hypoglycemia frequencies and mean event rates between the arms. Although baseline weights between the arms were substantially different, the change from baseline in weight was not significantly different with both arms gaining 1kg on average during the study duration.
Meanwhile, the adverse event profile between the arms was balanced. However, injection site pain was significantly higher in the BIOD-123 arm compared to Humalog (13.8% versus 1.5%).
Biodel expects to organize the full analysis of the data and submit an end of phase II meeting request to the U.S. Food and Drug Administration in the fourth quarter of 2013.
Biodel carries a Zacks Rank #4 (Sell). Currently, companies which look attractive include Gilead Sciences Inc. (GILD - Free Report) with a Zacks Rank #1 (Strong Buy).