TARRYTOWN, N.Y., Nov. 8 /PRNewswire-FirstCall/ -- Emisphere Technologies, Inc. announced today additional results from its 90-day, Phase 2 study of its oral insulin product utilizing the Company’s eligen(R) oral delivery technology.
Among all the patients, those on the high dose of oral insulin (10mg QID) had the most profound effect on HbA1c reduction:
* In patients with HbA1c levels at baseline between 7% and 8.9%, a decrease of 0.1% was seen in patients on oral insulin, versus an increase of 0.05% on placebo. * In patients with HbA1c levels of 7.5% to 8.9%, a decrease of 0.22% was seen in patients on oral insulin, versus an increase of 0.075% on placebo. * In patients with HbA1c levels of 8.0% to 8.9%, a statistically significant decrease of 0.74% was observed in patients on oral insulin, while no change (0.00%) was observed in patients on placebo (n=17, p=0.03)
In order for an efficacy determination to be made one requires a meaningful baseline measure. For efficacy evaluation purposes all patients whose screening to baseline HbA1c changed no more than 0.3% absolute were included in the efficacy database. For the safety evaluation all patients were included.
Also seen in these patients was a reduction of other glycemic parameters, such as fasting blood glucose, fructosamine and proinsulin, supporting that it was Emisphere’s high-dose oral insulin product that was responsible for the drop in patients’ HbA1c levels.
When further evaluating patients in the high dose oral insulin group, 2 of the 10 patients experienced a significant drop in HbA1c to 7% or lower while none of the placebo patients achieved this level of control. These patients both had HbA1c levels at baseline of 8.1%, and at day 90 had HbA1c levels of 7.0% and 6.0%, respectively. Patients with HbA1c levels of 7.0% or greater are classified as inadequately controlled diabetics.
In the high dose group, 4 out of the 10 patients experienced a decrease greater than or equal to 1% in HbA1c, while no patients in the placebo group experienced this magnitude of a drop, and 6 out of the 10 patients in the high dose group achieved a decrease greater than or equal to 0.7% in HbA1c vs. none in the placebo group.
Please see data slides related to today’s announcement on the investor relations portion of Emisphere’s website at www.emisphere.com/ir.asp.
“An in-depth analysis of our Phase 2 clinical data shows the potential of Emisphere’s oral insulin product to be beneficial and practical in a diverse population of Type II diabetics,” said Michael M. Goldberg, M.D., Chairman and CEO of Emisphere Technologies. “The study met the Company’s expectations that we could demonstrate the oral administration of insulin using our technology for 90 days, eliminate the key safety concerns associated with the administration of insulin and patient monitoring, and achieve statistical significance with a particular dose in a small Phase 2 trial. We believe these results will allow us to effectively pursue a partner for the drug.”
Enrollment Criteria
Patients enrolled in the trial were first observed for three weeks, and the variability of their HbA1c levels was monitored over this time. They were all on a fixed dose of a single oral agent, metformin, to treat their diabetes. The inclusion criteria for patients was a baseline HbA1c level of 7.0% - 9.5%.
During the initial monitoring stage, the three-week period between screening and baseline where there was no change in their treatment regimen and which was pre- randomization (n=91), patients’ HbA1c changed by as much as 1.2%. Evaluated in the efficacy endpoint in this clinical study were data from patients whose HbA1c levels did not change by more than 0.3% during the three week period.
The four arms of the study consisted of three doses of oral insulin (10mg four times daily, 10mg twice a day and 5mg four times daily) and placebo. There were 35 patients enrolled in each oral insulin arm of the trial, and 36 in placebo.
Emisphere’s oral insulin product demonstrated an encouraging safety profile. During the study, there were no statistically significant differences in hypoglycemic events, serious adverse events, or insulin antibody formation for our oral insulin product compared to placebo. The patients on high dose oral insulin saw no difference in weight and experienced no nighttime hypoglycemic events.
Webcast Information
Michael M. Goldberg, M.D. will present these results today during Emisphere’s presentation at the Rodman and Renshaw Healthcare Conference at 11:40 a.m. EST, and will also discuss these results when the Company holds its third quarter earnings results conference call on Thursday, November 9, 2006 at 10:00 a.m. EST. Investors may access the presentations within the investor relations portion of the Company’s website at http://www.emisphere.com/ir.asp.
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(R) 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 early stage diabetes.
About the eligen(R) Technology
Emisphere’s broad-based oral drug delivery technology platform, known as the eligen(R) technology, is based on the use of proprietary, synthetic chemical compounds, known as EMISPHERE(R) 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(R) 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(R) technology to those drugs or licensing its eligen(R) technology to partners who typically apply it directly to their marketed drugs. Emisphere’s eligen(R) 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 http://www.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.
Emisphere Technologies, Inc.
CONTACT: Stewart Siskind, Investor Relations, +1-914-785-4742, atEmisphere Technologies, Inc.; Dan Budwick, +1-212-477-9007 ext. 14, BMCCommunications, for Emisphere Technologies, Inc.
