) 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
In the randomized, open label, parallel group study, BIOD-123
was compared to
Eli Lilly and Company
) 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.
) 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.
) with a Zacks Rank #1 (Strong Buy).
BIODEL INC (BIOD): Free Stock Analysis Report
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LILLY ELI & CO (LLY): Free Stock Analysis
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