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

DANBURY, Conn., April 15, 2012 /PRNewswire/ -- Biodel Inc. (Nasdaq: BIOD) today 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).

  • BIOD-123 and BIOD-125 achieved the Company's target pharmacokinetic, pharmacodynamic and toleration profiles in a Phase 1 clinical trial; BIOD-123 favored as lead product candidate to advance to Phase 2
  • Projecting initiation of a Phase 2 clinical trial of BIOD-123 in the third calendar quarter of 2012
  • Continuing development of ultra-rapid-acting insulin analog-based formulations with selection of candidates and initiation of a Phase 1 clinical trial projected in the second half of calendar year 2012
  • Liquid glucagon formulation for use as a rescue treatment for patients experiencing severe hypoglycemia projected for NDA submission in the fourth calendar quarter of 2013 or first calendar quarter of 2014
  • The Phase 1 clinical trial evaluated the pharmacokinetic, pharmacodynamic and injection site toleration profiles of BIOD-123 and BIOD-125 relative to Humalog®, a rapid-acting insulin analog. The objective of the trial was to identify an RHI-based formulation with pharmacokinetic and pharmacodynamic profiles similar to the Company's previous Linjeta™ formulation 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. 

    Pharmacokinetic measurements were made using separate assays to quantify the active ingredients in the study drugs – RHI
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    SOURCE Biodel Inc.
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