Positive Results for Biodel’s Ultra Rapid Acting Insulin

April 16, 2012

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Biodel Inc. announced positive top-line results from a Phase 1 clinical trial of its product candidates, BIOD-123 and BIOD-125 — two proprietary ultra rapid acting formulations of recombinant human insulin (RHI). The objective of the trial was to identify an RHI-based formulation with pharmacokinetic and pharmacodynamic profiles similar to the company’s previous ultra rapid acting insulin formulation, Linjeta,  used in Phase 3 clinical trials, but with improved injection site toleration characteristics. 

The Phase 1 clinical trial was a single-center, randomized, double-blind, three-period crossover trial in 12 patients with type 1 diabetes.  Each study drug was administered subcutaneously on separate days with a washout period between injections. 

In the phase 1 clinical trial, absorption rates of Biodel’s ultra rapid acting insulin’s BIOD-123 and BIOD-125 were significantly faster than that of Humalog as indicated by 64% and 54% reductions, respectively.  In a previous clinical trial, the Linjeta formulation demonstrated a 61% reduction compared to Humalog.  Peak metabolic effects were not significantly different between the three study drugs. 

All three drugs were well tolerated, with injection site tolerability generally perceived by patients to be similar to that of their usual mealtime injections used at home.  As measured on a 100 mm visual analog scale in which 100 mm is defined as the worst possible injection discomfort, local toleration was not significantly different for BIOD-123 compared to Humalog.  The VAS score for BIOD-125 was slightly higher as compared to Humalog.  However, this score was markedly improved relative to the Linjeta formulation.

The encouraging findings from these studies  will enable Biodel to advance the ultra rapid acting insulin into a Phase 2 clinical trial as early as next quarter.  In parallel, the company will continue its 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.  
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