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...

Biodel’s ultra-rapid-acting formulations of recombinant human insulin, BIOD-105 and BIOD-107, failed to meet the company’s target product profile in the second phase 1 clinical trial at Oregon Health and Sciences University and will therefore not be advancing to phase 2 trials.  The top-line results from the phase 1 clinical trial of BIOD-105 and BIOD-107 was meant to evaluate the pharmacokinetic, pharmacodynamic and infusion site tolerability profiles of these ultra-rapid-acting formulations of recombinant human...

Biodel announced that an independent investigator initiated a pump trial of Biodel’s two ultra-rapid-acting formulations of recombinant human insulin. Biodel’s formulations, BIOD-105 and BIOD-107, are designed to result in more rapid insulin action compared to currently marketed mealtime insulin analogs. This study is designed as a double blinded, three-period cross over trial in which insulin pumps will be used to deliver BIOD-105, BIOD-107 and Humalog each at separate dosing visits in approximately 8 patients...

Biodel Inc. has selected two new formulations of recombinant human insulin for clinical testing and is accelerating clinical development plans of these mealtime insulin drug candidates. The new formulations, BIOD-105 and BIOD-107, are designed to result in more rapid insulin action compared to currently marketed meal time insulin analogs while maintaining an injection site tolerability profile comparable to currently marketed insulins.  Biodel plans to test these formulations in a Phase 1 clinical trial of approximately...

Scientists from Biodel Inc.  reported new findings from the company’s Linjeta™, insulin glargine, “smart” basal insulin and stabilized glucagon development programs in poster presentations at the Tenth Annual Diabetes Technology Meeting in Bethesda, MD. Dr. Frank Flacke presented results of a Phase 1 single-center, double-blind, randomized crossover trial in 13 subjects with type 1 diabetes who received a once-daily injection of Linjeta™ or one of two modified formulations of Linjeta™, each on a separate...

The U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) requesting additional information regarding Biodel Inc.’s new drug application (NDA) for Linjeta a more-rapid-acting human insulin injection for the treatment of type 1 and type 2 diabetes. The CRL stated that the FDA’s review cycle is complete and that the application cannot be approved in its present form.The CRL included comments related to clinical trials, statistical analysis and chemistry, manufacturing and controls. Biodel...

Biodel Inc. researchers presented results of a clinical study evaluating a new pH-neutral formulation of Linjeta(TM) (VIAject(R)) at the 46th annual meeting of the European Association for the Study of Diabetes (EASD) in Stockholm today. Dr. Tim Heise (Profil Institute for Metabolic Research, Neuss, Germany) and colleagues reported that the new pH-neutral, 100 IU/ml formulation of Linjeta(TM) was bioequivalent to the previously studied pH-4, 25 IU/ml formulation of Linjeta(TM), and had faster absorption and onset of action...

Biodel Inc. reported results of preclinical tests which demonstrated the potential of the company’s glucose-regulated or “smart” basal insulin product candidate, BIOD620, to release insulin proportionally in response to changing glucose conditions. In an oral presentation today at the 37th Annual Meeting and Exposition of the Controlled Release Society in Portland, Oregon, Nandini Kashyap, director of novel drug delivery at Biodel, described results of in vitro and in vivo studies with diabetic pigs which compared...

Biodel Inc. announced the award of two research grants by the Juvenile Diabetes Research Foundation (JDRF) to Stanford University and Oregon Health & Science University (OHSU) to evaluate the use of VIAject(R) (ultra-rapid-acting injectable human insulin) in the treatment of diabetes. The first grant will support clinical testing under the direction of Bruce Buckingham, M.D., professor of pediatrics at Stanford University School of Medicine, to compare the effects of VIAject(R) and Humalog(R) (insulin lispro) on postprandial...

Biodel Inc. announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the company’s new drug application seeking approval to market VIAject(R) for the treatment of diabetes. VIAject(R) is Biodel’s proprietary formulation of recombinant human insulin that is designed to be absorbed into the blood faster than currently marketed rapid-acting insulin analogs. The new drug has been tested in more than 875 patients who participated in Phase 1, 2 and...