Baxter Presents Phase I Inhaled Insulin Study Results
Baxter Healthcare Corporation announced results of a Phase I study that evaluated pulmonary insulin produced with Baxter's PROMAXX microsphere technology and administered using a small, standard dry powder inhaler.
Baxter presented the Phase I data earlier this week at the Respiratory Drug Delivery Europe 2007 Conference in Paris.
The study demonstrates that the insulin powder can be effectively administered to the deep lung using an off-the-shelf dry powder inhaler designed for upper airway drug delivery. A total of 30 subjects participated in the randomized, two-way crossover study conducted in Germany. Each subject received in randomized fashion a single dose of 10 International Units of insulin through subcutaneous injection (SC) in one period, and 6.5 milligrams of the inhaled insulin microspheres, called recombinant human insulin inhalation powder (RHIIP) in the other period.
RHIIP is made using Baxter's proprietary PROMAXX formulation technology. Unlike other dry powder formulations of insulin, RHIIP is 95 percent insulin and does not rely on the use of inactive ingredients to facilitate delivery to the deep lung. In this study, no serious adverse events were reported and no subjects withdrew from the study due to an adverse event. All adverse events were mild in severity. The most common reported treatment-emergent adverse event was phlebitis. There were no reported episodes of cough or shortness of breath in this study.
Study data show that RHIIP had a faster onset of action than SC (time to reach 10 percent of total area under the glucose infusion rate (GIR) curve 73 vs 95 min.; GIR-tmax 173 versus 218 min., p<0.0001). Duration of action (371 vs 366 min.) and total metabolic effect (GIR-AUC0-10h of 2,734 vs 2,482 mg/kg) were comparable. Pharmacokinetic results were in accordance with these findings: RHIIP was absorbed faster (time to reach 10 percent of total area under the insulin curves 44 vs 66 min., p<0.0001), and maximum insulin levels were reached earlier (86 vs 141 min., p=0.002). The bioavailability of RHIIP relative to SC was more than 12 percent.
"These encouraging results show the bioavailability of RHIIP compare favorably with that observed for many other inhaled insulin preparations, even though the standard type of inhaler used in this study was not optimized for delivery of insulin to the deep lung," said Dr. Tim Heise, Profil Institut fur Stoffwechselforschung GmbH in Neuss, Germany, and principal investigator for the study. "RHIIP may have the potential to achieve even higher bioavailability through further improvements in the insulin delivery technique, and this will be the subject of further studies."
"We are very excited to share these results that illustrate the strong potential of PROMAXX technology," said Peter J. Arduini, corporate vice president and president of Baxter's Medication Delivery business. "We look forward to working with partners to apply this technology broadly to the formulation of therapeutic proteins and peptides."