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Biodel Reports Positive Top-Line Results from Study of Experimental Ultra-Rapid-Acting Insulin Formulations
Date:4/15/2012

a-rapid absorption profile of Linjeta™, while improving injection site toleration.  These recent data suggest that our latest formulations have achieved this goal, and we feel that further clinical development is warranted." 

Dr. Errol De Souza, Biodel's president and chief executive officer, stated: "The findings from these studies are very encouraging and will enable us to advance an ultra-rapid-acting RHI-based formulation into a Phase 2 clinical trial as early as next quarter.  In parallel, we will continue our development of ultra-rapid-acting insulin analog-based formulations, with the goal of advancing product candidates into a Phase 1 clinical trial later in 2012.  We expect our ultra-rapid-acting insulin program, along with our liquid glucagon rescue program that is targeted for NDA filing by the end of 2013 or early 2014, to generate multiple meaningful milestones in the short-term." 

Phase 1 Study in Patients with Type 1 Diabetes (n=12)Pharmacokinetic Profiles of BIOD-123, BIOD-125 and Humalog® Treatment

MetricsEarly 1/2 Tmax

(minutes)

Tmax

(minutes)

Late 1/2 Tmax

(minutes)Humalog®

27.0 +/- 2.7

(25.9)

65.0 +/- 7.0

(67.5)

151 +/- 11

(150)BIOD-123

9.8 +/- 1.1*

(9.6)

46.4 +/- 14.9

(25.0)

206 +/- 35

(170)BIOD-125

12.4 +/- 2.0*

(9.4)

60.8 +/- 15.2

(30.0)

179 +/- 41

(140)-- Data represent the Mean +/- SEM; Median Values are presented in parentheses. 

* p<0.001 vs. Humalog® Injection Site Toleration Profiles of BIOD-123, BIOD-125 and Humalog®Treatment

MetricsTolerability

(VAS 0 – 100mm)

Absolute Severity

Score

Relative Severity ScoreHumalog®

1.8  +/- 1.1

0.17 +/-  0.11

2.92 +/-  0.08 BIOD-123
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SOURCE Biodel Inc.
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