Oramed Pharmaceuticals Inc. (NASDAQ: ORMP) (TASE: ORMP) (www.oramed.com), a clinical-stage pharmaceutical company focused on the development of oral drug delivery systems, announced that it has initiated a food effect study in the U.S. for its oral insulin capsule ORMD-0801.
The food effect study is a single-blind, five period, randomized, placebo-controlled crossover study to evaluate the pharmacokinetics and pharmacodynamics of ORMD-0801 taken at different times in relation to meals in healthy volunteers and subjects with type 1 diabetes. Up to 48 subjects will be enrolled including 24 healthy volunteers and 24 subjects with type 1 diabetes.
“Following a successful Phase 2 study which demonstrated ORMD-0801’s use before mealtime in type 1 diabetics, this food effect study will further explore the optimal timing of ORMD-0801 dosing relative to food intake,” stated Nadav Kidron, CEO of Oramed.
On June 19th, Oramed announced also that it will be added to the FTSE Russell Microcap® Index effective at the open of the market on June 25, 2018, as part of the Russell Indexes annual reconstitution. Membership in the Russell Microcap® Index, which remains in place for one year, means automatic inclusion in the applicable growth and value style indexes.
CNN quoted Oramed CEO Nadav Kidron in a June 25 article “Insulin pill instead of shot: How close are we for diabetes patients?” :
“A year from now we will better know the potential of our drug to control and maintain blood glucose levels and will have further proof of the longer-term benefits of taking an oral pill versus an injection,” Oramed CEO Nadav Kidron said in a news release in May. Last month, Oramed Pharmaceuticals launched the largest and most advanced clinical trial of its own oral insulin pill, under the direction of the US Food and Drug Administration. The trial involves 240 patients with Type 2 diabetes.
About Oramed Pharmaceuticals
Oramed Pharmaceuticals is a technology pioneer in the field of oral delivery solutions for drugs currently delivered via injection. Established in 2006, Oramed’s Protein Oral Delivery (PODTM) technology is based on over 30 years of research by top 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). The Company completed multiple Phase II 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 analog capsule (ORMD-0901).
For more information, the content of which is not part of this press release, please visit www.oramed.com
Source – https://www.biospace.com/article/releases/oramed-initiates-food-effect-study-for-its-oral-insulin-capsule-ormd-0801/?keywords=oramed