Tag Archives: ORMD-0801

Oramed Oral Insulin Ph2b Cohort B Results

Oramed announced positive topline results from Cohort B of the Ph2b trial evaluating its oral insulin (ORMD-0801) in T2DM patients. Oramed also hosted an associated call with investors to discuss the results. Recall, Oramed announced results from Cohort A of this Ph2b study in November 2019, which demonstrated a statistically significant result for the QD and BID doses but not with the TID dose (previous FENIX insight). Below, FENIX provides highlights of the new data and brief thoughts in the context of the previous Ph2b results, Tresiba’s CVOT (DEVOTE), and Novo’s QW basal insulin (icodec).

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Oramed Oral Insulin (ORMD-0801) Ph2b T2DM Results Unclear

Oramed announced topline results from the first cohort of the Ph2b study evaluating its prandial oral insulin (ORMD-0801) in T2DM patients. Of note, the study is evaluating QD, BID, and TID dosing, but only the QD and BID arms demonstrated a statistically significant result on A1C. Oramed projects data from the second cohort of this Ph2b study will be available in Q1 ’20. Below, FENIX provides thoughts on the potential commercial opportunity for oral insulin as well as unanswered questions into why the TID treatment arm did not reach statistical significance.

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