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Oramed Pharmaceuticals Announces First Patient Enrolled in a US Phase 2a Trial for ORMD-0801 in Treatment of Type 1 Diabetes
March 27, 2014 (The Wall Street Journal) — Oramed Pharmaceuticals Inc. (nasdaqcm:ORMP) ( http://www.oramed.com ), a clinical-stage pharmaceutical company focused on the development of oral drug delivery systems, announced today that the first patient has been enrolled in its U.S. Phase 2a trial for its orally ingestible insulin capsule, ORMD-0801, in the treatment of type 1 diabetes (T1DM).
"We are pleased to be initiating this U.S. clinical trial with ORMD-0801 in patients with type 1 diabetes following successful trials outside of the US," said Nadav Kidron, CEO of Oramed Pharmaceuticals. "This initiation is in parallel to the company gearing up for its multi-center Phase IIb study for the treatment of type 2 diabetics."
This Phase 2a clinical trial is a prospective, randomized, double-blind, placebo-controlled study designed to enroll up to 24 patients with type 1 diabetes in-clinic for 10 days. Patients will be randomized in a 2:1 ratio to receive either ORMD-0801 or placebo. The primary endpoint of the trial is to evaluate the change from baseline in exogenous insulin requirements (basal, bolus, and total) in patients treated with ORMD-0801, compared to the change from baseline for patients treated with placebo. Secondary endpoints include evaluating the change from baseline in mean nighttime, daytime, and fasting glucose levels in type 1 diabetes patients treated with ORMD-0801, compared to the change from baseline for patients treated with placebo. For more details on the trial, please visit http://www.clinicaltrials.gov.
About ORMD-0801 Oral Insulin and T1DM
Oramed proposes to introduce ORMD-0801 to reduce the mealtime insulin doses, introducing a treatment regimen which would allow for fewer daily injections. Moreover, oral administration offers the benefit of reduced systemic exposure and may enable tighter regulation of blood sugar levels by directly affecting glucose control in the liver. For more information on ORMD-0801, the content of which is not part of this press release, 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 (POD™) 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 GLP-1 analog capsule ( ORMD-0901 ). 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.