Biodel Inc. (BIOD) announced positive preliminary results from Study 3-151, a Phase 2a clinical trial comparing Biodel's proprietary, concentrated insulin formulation BIOD-531 to Humalog Mix 75/25 and Humulin R U-500 in patients with type 1 and type 2 diabetes with severe insulin resistance who use at least 150 units of insulin per day or at least 100 units of insulin in a single injection.
Many type 2, and some type 1, diabetes patients in clinical practice are treated with pre-mixed insulins, such as Humalog Mix 75/25, in order to receive both basal and prandial insulin in single injections. Pre-mixed insulin is commonly dosed before breakfast and before dinner and is usually used in patients who are not candidates for an intensive basal-bolus insulin regimen which often requires four or more injections per day.
Humulin R U-500 is used most commonly to treat type 2 diabetes patients with severe insulin resistance who require very high doses of insulin -- typically greater than 150 units per day. Humulin R U-500 is currently the only concentrated insulin available in the U.S.
BIOD-531 is an ultra-rapid-acting formulation of recombinant human insulin (RHI) at a concentration of 400 units/ml (U-400) combined with EDTA, citrate and magnesium sulfate. In the Phase 1 Study 3-150, BIOD-531 administered to non-diabetic, obese volunteers demonstrated ultra-rapid absorption and onset of action compared to Humalog Mix 75/25 and Humulin R U-500, and had an extended duration of action expected to be suitable for basal insulin needs.
The Phase 2a Study 3-152 demonstrated that a single dose of BIOD-531 conferred better postprandial glucose control for two consecutive meals compared to Humalog Mix 75/25 or Humulin R U-500 when administered to type 2 diabetes patients with moderate insulin resistance (insulin dose requirement between 50-150 units/day). Postprandial glucose control with BIOD-531 dosed after the standardized meal was also superior to the control provided by the comparators dosed prior to the standardized meal.
The results of this recently completed Phase 2a Study 3-151 demonstrate that BIOD-531 may confer similar clinically meaningful benefits of superior mealtime coverage and adequate basal duration for diabetes patients with higher degrees of insulin resistance and insulin dose requirements.
BIOD-531 was associated with superior glucose control compared to Humalog® Mix 75/25 during the post-breakfast period (the primary efficacy endpoint for the study) and throughout the 24-hour period of observation. BIOD-531 administered immediately before breakfast (pre-meal) achieved significantly lower mean glucose concentrations than did Humalog Mix 75/25 administered immediately before breakfast.
BIOD-531 dosed 20 minutes after the start of the standardized breakfast and dinner resulted in superior glucose control over the 24-hour period of observation compared to Humalog Mix 75/25 dosed prior to the meals. Mean glucose concentrations over the 24-hour period were 149.8 ± 11.8 mg/dl for post-meal BIOD-531 treatment compared to 172.6 ± 14.0 mg/dl for pre-meal Humalog Mix 75/25 treatment (p=0.006). The percentage of readings within the 70-180 mg/dl target range was 71.5 ± 8.1% for post-meal BIOD-531 treatment compared to 55.7 ± 9.9% for pre-meal Humalog Mix 75/25 treatment (p=0.025). Post-meal dosing of BIOD-531 resulted in similar overall glycemic control as observed with pre-meal Humulin R U-500 treatment.
BIOD closed Wednesday trading at $1.45 down $0.01 or 0.68%. however, in after hours, the stock surged $0.46 or 31.72%.
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