Emisphere Technologies Demonstrates Safety and Efficacy of Oral Insulin in Phase 2 Trial in Type 2 Diabetics
Monday October 30, 9:21 am ET
Company to Hold Conference Call at 10:30 am Eastern Time Today
TARRYTOWN, N.Y.--(BUSINESS WIRE)--
Oral insulin had no statistical difference in hypoglycemic episodes, serious adverse events, or insulin antibodies versus placebo
A dose response was observed for the active arms versus placebo in the diabetic patients on the highest doses of metformin enrolled in the study
Emisphere Technologies, Inc. ("Emisphere", NASDAQ: EMIS) announced today results from its 90-day, Phase 2 study of its oral insulin product utilizing its eligen® oral delivery technology. The four-arm study evaluated the safety and efficacy of low and high fixed doses of oral insulin tablets versus placebo in patients with Type 2 Diabetes Mellitus on existing oral metformin monotherapy. The trial focused on the safety of oral insulin, specifically noting incidents of hypoglycemia, as well as the occurrence of insulin antibodies. The efficacy component of the trial was designed to measure changes in Hemoglobin A1c (HbA1c) over 90 days, the standard for evaluating glucose control in Type II diabetics. An additional objective was to confirm that insulin delivered orally could be administered as a fixed dose product without the need to conduct glucose monitoring or titrate the insulin dose. The study met the Company's objectives for both safety and efficacy.
The four arms of the study consisted of three doses of oral insulin (10mg QID, 5 mg QID and 10 mg BID) and placebo. There were 35 patients enrolled in each oral insulin arm of the trial, and 36 in placebo. Results showed that the total number of patients achieving a hemoglobin A1c (HbA1c) decrease of more than 1.1% among the 35 patients dosed at the 10 mg QID dose of oral insulin was statistically significantly higher than in the 36 placebo patients (p=0.0368). The study also demonstrated it was possible to deliver a fixed dose of insulin without the need to frequently monitor the patients' blood glucose or to titrate the dose for any reason. Blood glucose was measured on a monthly basis. A dose response was observed in Hba1c for the 10 mg QID and 5 mg QID doses of oral insulin versus placebo in patients enrolled with Hba1c values above 7.5% and being treated with 1,500 mg per day or more of metformin; however, these values did not reach statistical significance.
Emisphere believes its oral insulin product had a very encouraging safety profile. During the study, there were no significant differences in number of hypoglycemic events, serious adverse events, or insulin antibody formation for the orally administered insulin compared to placebo. There were no hypoglycemic events in any of the high responder patients as measured by HbA1c. There were no insulin antibodies in any of the three oral insulin arms. The patients in all three active arms saw no change in weight and no nighttime hypoglycemic events.
"We are very pleased with these study results. The goal of this study was to demonstrate that orally dosed insulin can be effective and safe in a real world setting over a protracted period of time, 90 days, without the need to titrate the dose or frequently monitor the blood glucose levels. Such a product can improve both the quality of care and the quality of life for many diabetics" said Michael M. Goldberg, M.D., Chairman and CEO of Emisphere Technologies. "The oral delivery of insulin has been an important goal of the pharmaceutical industry since insulin's discovery over 80 years ago. The results from this Phase 2 study represent a major milestone in Emisphere's efforts toward the accomplishment of that goal. The Phase 2 clinical trial was also designed to evaluate the safety and efficacy of various dosage strengths of our product compared to placebo. In- depth analysis of the data from this study should better define the patient populations most likely to benefit from the unique characteristics of oral insulin"
"This important achievement could not have been accomplished without the dedication and commitment of our staff and our expert collaborators from around the world. We were pleased with the quality and performance of our contract research organization, iGate, whose execution skills were excellent throughout the study. We look forward to extending our clinical database to further investigate the principal subpatient populations that would most benefit from the oral insulin product. We believe that these results will support our efforts to partner this program with a major pharmaceutical company. Finally while the phase 2 study was being conducted we tested several new oral insulin formulations in humans, which are more efficient in delivering insulin as compared to the formulation used in the phase 2." Dr. Goldberg concluded.
"We were very pleased to have had the opportunity to work on such an exciting and novel product. The investigators involved in the study consistently commented on the excellent safety and tolerability of the Emisphere oral insulin product. Significant interest was expressed by the investigators and their patients in an oral insulin product, which will not require dose titration or frequent glucose monitoring" said Vasu Ginde M.D., CEO of iGate Clinical Research International.
Conference Call/Webcast Information
The Company will hold a conference call today at 10:30 am to discuss these results. The dial-in information is as follows:
U.S. Dial-In: (866) 541-8090
International Dial-In: (706) 758-0055
Passcode: 1095920
This conference call will also be broadcast live via the Internet. You may access the presentation by visiting the Investor Relations portion within the Emisphere Technologies' website, emisphere.com.
Please visit the site at least five minutes prior to start time for instructions. A replay will be available through November 29, 2006. To access the replay, callers are requested to dial (800) 642-1687 from the U.S. and (706) 645-9291 internationally. Callers should use passcode 1095920.
About Diabetes
According to statistics provided by the World Health Organization and the American Diabetes Association, approximately 177 million people worldwide are afflicted by diabetes, with approximately 18 million of those afflicted residing in the United States. Nearly one-third of all individuals in the United States suffering from diabetes are unaware that they have this chronic disease. Type 2 diabetics account for approximately 90-95% of diabetes cases. According to the publicly filed annual reports of leading insulin manufacturers, worldwide sales of insulin were approximately $5.6 billion in 2004. Currently, there are no approved insulin therapies in oral form.
About EMISPHERE® Oral Insulin
Emisphere's oral insulin mimics the natural physiology of insulin release, by targeting the liver prior to being distributed to the peripheral circulation, so that both the timing and location of naturally secreted (endogenous) insulin release are replicated. Orally delivered insulin, with the appropriate clinical attributes, may provide for an effective diabetes therapy with fewer side-effects as compared to existing therapies, and may be useful in halting the progression of diabetes.
About the eligen® Technology
Emisphere's broad-based oral drug delivery technology platform, known as the eligen® technology, is based on the use of proprietary, synthetic chemical compounds, known as EMISPHERE® delivery agents, or "carriers". These molecules facilitate or enable the transport of the therapeutic macromolecules across biological membranes such as those of the gastrointestinal tract, and exert their desired pharmacological effect. Emisphere's eligen® technology makes it possible to orally deliver a therapeutic molecule without altering its chemical form or biological integrity.
About Emisphere Technologies, Inc.
Emisphere Technologies, Inc. is a biopharmaceutical company pioneering the oral delivery of otherwise injectable drugs. Emisphere's business strategy is to develop oral forms of injectable drugs, either alone or with corporate partners, by applying its proprietary eligen® technology to those drugs or licensing its eligen® technology to partners who typically apply it directly to their marketed drugs. Emisphere's eligen® technology has enabled the oral delivery of proteins, peptides, macromolecules and charged organics. Emisphere and its partners have advanced oral formulations or prototypes of salmon calcitonin, heparin, insulin, parathyroid hormone, human growth hormone and cromolyn sodium into clinical trials. Emisphere has strategic alliances with world-leading pharmaceutical companies. For further information, please visit emisphere.com.
Safe Harbor Statement Regarding Forward-looking Statements
The statements in this release and oral statements made by representatives of Emisphere relating to matters that are not historical facts (including without limitation those regarding the timing or potential outcomes of research collaborations or clinical trials, any market that might develop for any of Emisphere's product candidates and the sufficiency of Emisphere's cash and other capital resources) are forward-looking statements that involve risks and uncertainties, including, but not limited to, the likelihood that future research will prove successful, the likelihood that any product in the research pipeline will receive regulatory approval in the United States or abroad, the ability of Emisphere and/or its partners to develop, manufacture and commercialize products using Emisphere's drug delivery technology, Emisphere's ability to fund such efforts with or without partners, and other risks and uncertainties detailed in Emisphere's filings with the Securities and Exchange Commission, including those factors discussed under the caption "Risk Factors" in Emisphere's Annual Report on Form 10-K (file no. 1-10615) filed on March 16, 2006.
Contact:
Investor Relations:
Emisphere Technologies, Inc.
Stewart Siskind, 914-785-4742
or
Media:
BMC Communications
Dan Budwick, 212-477-9007 ext. 14 |
