Tag Archives: ORMP

Oramed Oral GLP-1RA Receives IND Approval

Oramed announced FDA cleared its IND application for ORMD-0901, an oral GLP-1RA believed to be using exenatide. According to the press release, Oramed is planning to initiate a Ph1 PK study in Q3 ’18 with intentions to move into Ph2 in 2019. The Ph1 study has not yet been posted on CT.gov, but the press release said the Ph1 study will be a 4-way crossover vs. Byetta in 15 healthy subjects. Below, FENIX provides thoughts on ORMD-0901 in the context of Novo’s oral semaglutide.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

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New Oramed Oral Insulin Ph2b Study Initiated

Oramed has initiated a Ph2b dose ranging study evaluating its oral insulin (ORMD-0801) in T2DM subjects (CT.gov record). According to the press release, the trial is a “prerequisite to Phase 3 confirmatory studies under FDA’s BLA.”

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

If you receive our email blasts, you already have an account.

Purchase Blast$599.00

You can read the article’s full content online after purchase.