Monday, March 30, 2020

Monday, March 30, 2020

ORAMED: Receives Positive Feedback From End-of-Phase 2 Oral Insulin CMC Meeting With FDA


Oramed Pharmaceuticals Inc. issued the following announcement on March 19.

Oramed Pharmaceuticals Inc. (Nasdaq: ORMP) (TASE: ORMP) (www.oramed.com), a clinical-stage pharmaceutical company focused on the development of oral drug delivery systems, today announced positive feedback from its initial End-of-Phase 2 (EoP2) meeting with the U.S. Food and Drug Administration (FDA) to discuss Chemistry Manufacturing and Control (CMC) of its lead oral insulin capsule ORMD-0801.

The meeting, held in February, followed the successful completion of Oramed's Phase 2b trial of ORMD-0801 for the treatment of type 2 diabetes (See Press Release dated November 12, 2019), which achieved its primary endpoint, the reduction in HbA1c compared to placebo at week 12.  

During this meeting the FDA provided feedback on key issues relating to Drug Product manufacture and supported continuing to Phase 3 clinical development. The Company expects an additional meeting with the FDA following deeper analysis of the data from the Phase 2b trial, during which the Company anticipates receiving the FDA's guidance on the Phase 3 study design.

Oramed's Chief Executive Officer, Nadav Kidron, said, "We are very pleased with the productive and constructive feedback from the FDA as we continue on the path to bring oral insulin to market.  We look forward to further discussions with the FDA and to their guidance in regards to our anticipated Phase 3 trial."

About Oramed Pharmaceuticals

Oramed Pharmaceuticals is a platform technology pioneer in the field of oral delivery solutions for drugs currently delivered via injection. Established in 2006, with offices in New York and Israel, Oramed has developed a novel Protein Oral Delivery (POD™) technology that is based on more than 30 years of research by scientists at Jerusalem's Hadassah Medical Center. Oramed is seeking to revolutionize the treatment of diabetes through its proprietary lead candidate, ORMD-0801, which has the potential to be the first commercial oral insulin capsule for the treatment of type 2 and type 1 diabetes. The Company has completed multiple Phase 2 clinical trials under an Investigational New Drug application with the U.S. Food and Drug Administration. In addition, Oramed is developing an oral GLP-1 (Glucagon-like peptide-1) analog capsule, ORMD-0901.

For more information, please visit www.oramed.com.

Original source can be found here.

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