Company to Move Forward with FDA Phase 2b Multi-Center Trial
JERUSALEM, Israel I January 30, 2014 I Oramed Pharmaceuticals Inc. (NASDAQCM: ORMP), a developer of oral drug delivery systems, announced today results from its Phase 2a clinical trial for its ORMD-0801 oral insulin capsule for the treatment of type 2 diabetes. The trial was conducted under a United States Food and Drug Administration (FDA) IND (Investigational New Drug) protocol. The Phase 2a study met all primary and secondary endpoints.
30 patients with type 2 diabetes took part in the trial in an in-patient setting for one week. Endpoints of safety as well as pharmacodynamic and pharmacokinetic effects were evaluated against a placebo control. For full information on the Phase 2a trial design and endpoints please see Clinical Trials*. Further information on the safety results of the Phase 2a clinical trial can be found on Oramed’s website. Full results are expected to be presented at a scientific conference in the future.
“We are extremely pleased with the results which give a solid validation for Oramed’s platform technology in general and our oral insulin program in particular,” stated Oramed CEO Nadav Kidron. “Following on the results from this type 2 diabetes study we are gearing up to start a multi-center Phase 2b study later this year. We are also excited about the potential of this drug for type 1 diabetes and plan to initiate a Phase 2a FDA study for this indication in the near term.”
About ORMD-0801 Oral Insulin
Oramed’s ORMD-0801 is an orally ingestible insulin capsule for the early stages of type 2 diabetes, when it can still slow the rate of degeneration of the disease by providing additional insulin to the body and allowing pancreatic respite. Moreover, orally administered insulin has the potential benefit of enhanced patient compliance at this crucial stage as well as the advantage of mimicking insulin’s natural location and gradients in the body by first passing through the liver before entering the bloodstream. For more information on ORMD-0801, please visit: http://oramed.com/index.php?page=14*
About Oramed Pharmaceuticals
Oramed Pharmaceuticals is a technology pioneer in the field of oral delivery solutions for drugs and vaccines currently delivered via injection. Established in 2006, Oramed’s Protein Oral Delivery (PODTM) technology is based on over 30 years of research by top research scientists at Jerusalem’s Hadassah Medical Center. Oramed is seeking to revolutionize the treatment of diabetes through its proprietary flagship product, an orally ingestible insulin capsule (ORMD-0801) currently in Phase 2 clinical trials on patients with type 2 diabetes (T2DM) under an Investigational New Drug application with the U.S. Food and Drug Administration, and with its oral exenatide capsule (ORMD-0901; a GLP-1 analog). Oramed is also moving forward with clinical trials of ORMD-0801 for the treatment of type 1 diabetes. The company’s corporate and R&D headquarters are based in Jerusalem.
SOURCE: Oramed Pharmaceuticals
Post Views: 908
Company to Move Forward with FDA Phase 2b Multi-Center Trial
JERUSALEM, Israel I January 30, 2014 I Oramed Pharmaceuticals Inc. (NASDAQCM: ORMP), a developer of oral drug delivery systems, announced today results from its Phase 2a clinical trial for its ORMD-0801 oral insulin capsule for the treatment of type 2 diabetes. The trial was conducted under a United States Food and Drug Administration (FDA) IND (Investigational New Drug) protocol. The Phase 2a study met all primary and secondary endpoints.
30 patients with type 2 diabetes took part in the trial in an in-patient setting for one week. Endpoints of safety as well as pharmacodynamic and pharmacokinetic effects were evaluated against a placebo control. For full information on the Phase 2a trial design and endpoints please see Clinical Trials*. Further information on the safety results of the Phase 2a clinical trial can be found on Oramed’s website. Full results are expected to be presented at a scientific conference in the future.
“We are extremely pleased with the results which give a solid validation for Oramed’s platform technology in general and our oral insulin program in particular,” stated Oramed CEO Nadav Kidron. “Following on the results from this type 2 diabetes study we are gearing up to start a multi-center Phase 2b study later this year. We are also excited about the potential of this drug for type 1 diabetes and plan to initiate a Phase 2a FDA study for this indication in the near term.”
About ORMD-0801 Oral Insulin
Oramed’s ORMD-0801 is an orally ingestible insulin capsule for the early stages of type 2 diabetes, when it can still slow the rate of degeneration of the disease by providing additional insulin to the body and allowing pancreatic respite. Moreover, orally administered insulin has the potential benefit of enhanced patient compliance at this crucial stage as well as the advantage of mimicking insulin’s natural location and gradients in the body by first passing through the liver before entering the bloodstream. For more information on ORMD-0801, please visit: http://oramed.com/index.php?page=14*
About Oramed Pharmaceuticals
Oramed Pharmaceuticals is a technology pioneer in the field of oral delivery solutions for drugs and vaccines currently delivered via injection. Established in 2006, Oramed’s Protein Oral Delivery (PODTM) technology is based on over 30 years of research by top research scientists at Jerusalem’s Hadassah Medical Center. Oramed is seeking to revolutionize the treatment of diabetes through its proprietary flagship product, an orally ingestible insulin capsule (ORMD-0801) currently in Phase 2 clinical trials on patients with type 2 diabetes (T2DM) under an Investigational New Drug application with the U.S. Food and Drug Administration, and with its oral exenatide capsule (ORMD-0901; a GLP-1 analog). Oramed is also moving forward with clinical trials of ORMD-0801 for the treatment of type 1 diabetes. The company’s corporate and R&D headquarters are based in Jerusalem.
SOURCE: Oramed Pharmaceuticals
Post Views: 908
