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 day (“Characterization of Pharmacokinetics and Toleration of Three Variant Formulations of Linjeta™”). The purpose of the study was to compare the pharmacokinetic characteristics and toleration of Linjeta™ to the two modified formulations. The study found that the modified formulations were associated with improved toleration profiles and lower maximal insulin concentrations compared to Linjeta. Modified formulation BIOD-102 was associated with a similar rate of absorption as Linjeta.
Dr. Roderike Pohl reported results of in vitro and preclinical testing of a modified form of insulin glargine in diabetic miniature swine to assess its duration of activity and pharmacokinetic profile compared to insulin glargine (“A New Formulation of Insulin Glargine with an Extended Release Profile”). The study found that certain excipients, when combined with insulin glargine, reduced the drug’s solubility and could prolong its duration of action to greater than 24 hours compared to an average 18.5 hours for insulin glargine.
Nandini Kashyap described results of in vitro and in vivo studies in diabetic swine which showed that a “smart” basal insulin formulation can release insulin in response to changing glucose concentrations (“Smart Basal Insulin Formulation That Releases Insulin in Response to Changing Blood Glucose Concentrations”). This suggests that a modified form of basal insulin can be regulated based on insulin need, which would be expected to result in fewer hyper- and hypoglycemic excursions.
Dr. Solomon Steiner announced progress in the development of a stable form of glucagon for potential use in automated bihormonal pumps that deliver insulin and glucagon (“A Stabilized Glucagon Formulation For Bihormonal Pump Use”). Although generally unstable, glucagon can be used to prevent the hypoglycemia which occurs as a result of low or falling glucose concentration when too much insulin is administered. Biodel’s glucagon was found to be chemically and physically stable beyond seven days and physiologically active after three days of exposure in diabetic miniature swine, suggesting its utility for use in a bihormonal pump.
These poster presentations are available on the company’s website, www.biodel.com.
Dr. Steiner, Biodel’s chief scientific officer, commented: “These presentations highlight the many applications of our drug delivery technology as well as the potential of our product candidates to improve the treatment and quality of life of people with diabetes. The new formulations of Linjeta™, insulin glargine, ‘smart’ basal insulin and stabilized glucagon described in these abstracts appear to improve the tolerability, pharmacokinetic activity, and in some instances stability, of the unmodified forms of these compounds. We look forward to validating our findings by advancing our product candidates through clinical testing.”
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