Emisphere Technologies Announces Clinical Results From Three Oral Insulin Studies
NEW YORK, Sept. 7 /PRNewswire/ -- Emisphere Technologies, Inc. (Nasdaq: EMIS - news) announced today the results from three Phase I studies evaluating two of its proprietary drug delivery agents (carriers) for the oral delivery of insulin. The data, presented at an Emisphere-sponsored Investor Day held at The Plaza Hotel in New York City, demonstrated absorption from the gastrointestinal tract with oral formulations of insulin, as well as significant reductions in blood glucose levels.
The first study, conducted by Hadassah Medical Center in Israel, consisted of the administration of insulin with an EMISPHERE® carrier in a capsule formulation to twelve healthy human volunteers who received one dose each, ranging from 200 to 405 units of insulin with carrier doses of 1.4 to 2.1g. The second study, conducted in The Netherlands, also consisted of insulin administration with the same EMISPHERE® carrier in a capsule formulation to six healthy human volunteers who received four different doses, ranging from 100 to 350 units of insulin and 1.4 to 2.1g of carrier, with another two subjects who received either the delivery agent alone at a dose of 2,100 mg or insulin alone at a dose of 350 units as a control. Emisphere also presented preliminary data from a third study that is being conducted in the U.K., and consists of oral insulin administration with an EMISPHERE® carrier that was selected and evaluated specifically for insulin, in 10 healthy human volunteers receiving three different doses, ranging from 100 to 150 units of insulin and 0.2 to 0.6g of carrier, and a subcutaneous control.
In all three studies, wherein one of Emisphere's proprietary carriers was used in combination with insulin in an oral formulation, Emisphere was able to demonstrate absorption from the gastrointestinal tract of clinically significant levels following oral dosing, with systemic concentrations reaching as high as 288uU/mL in one study. The data also demonstrated a rapid drop in blood sugar following oral insulin administration, with reductions up to 63% as well as a consistent compensatory decline in C-Peptide levels. In addition, the orally delivered insulin had favorable pharmacokinetic and pharmacodynamic profiles, in that systemic blood insulin levels peaked at 25 minutes, and the maximum drop in blood glucose levels were seen 40 minutes after dosings. The studies demonstrated the safety and tolerability of both formulations. There were no serious adverse events or drug related side effects in any of the studies. The resulting preliminary data of the U.K.-conducted study suggested that the carrier specifically designed for insulin is the more effective of the two carriers tested.
Michael M. Goldberg, M.D., Chairman and Chief Executive Officer of Emisphere, stated, ``We are extremely excited about the data from all three studies. Since insulin's discovery in 1921 there has been a concerted effort to develop an oral formulation. The results from these three studies met all of our expectations for the clear demonstration of the proof-of-concept. We are eager to partner this product with a suitable pharmaceutical company that can assist us in the rapid clinical development of a product that has the potential to significantly impact the lives of tens of millions of patients worldwide.''
Alan C. Moses, M.D., Chief Medical Officer and Senior Vice President, Joslin Diabetes Center, an affiliate of Harvard Medical Center, stated, ``The data are exciting on several levels. Besides demonstrating insulin absorption in the gastrointestinal tract, the studies were able to demonstrate a reduction in blood sugar levels appropriate for the serum insulin levels, a fast onset of action and a (dose-dependant) therapeutic response. The ability to deliver insulin into the liver before it reaches the systemic circulation is an important step in providing more physiological insulin delivery, something that investigators have been trying to do since the discovery and isolation of insulin. If oral insulin can be developed successfully, it will provide patients with diabetes a highly desirable option for insulin delivery that can be used early in type 2 diabetes and that can be used in combination with a single long-acting injection of insulin in type 1 diabetes.''
Insulin represents Emisphere's second protein to enter human testing. Emisphere believes that an oral insulin product has the potential to benefit diabetics currently using subcutaneous insulin related to both patient compliance and physiological efficiency. Orally delivered insulin is expected to have distinct advantages over alternative delivery options, because it is delivered directly to the portal circulation and then to the liver, which is consistent with normal physiology. |
