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I"},{"orgOrder":0,"company":"Oramed Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Oramed Reaches 50% Enrollment in its Second Phase 3 Oral Insulin Trial","therapeuticArea":"Endocrinology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Peptide","productStatus":"Approved","date":"July 2022","url1":"","url2":"","graph1":"Endocrinology","graph2":"Phase III"},{"orgOrder":0,"company":"Oramed Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Oramed Reports Positive Top-Line Results from Phase 2 NASH Trial with its ORMD-0801, Oral Insulin Candidate","therapeuticArea":"Endocrinology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Peptide","productStatus":"Approved","date":"September 2022","url1":"","url2":"","graph1":"Endocrinology","graph2":"Phase 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Find Clinical Drug Pipeline Developments & Deals by Oramed Pharmaceuticals
ORMD-0801 (oral insulin) capsule, with enhanced patient compliance, is currently undergoing phase III clinical trials for the T2DM indication. Drug has the potential to delay the disease progression or even eliminating late-stage complications.
ORMD-0801 (oral insulin) Capsule, with enhanced patient compliance, is currently undergoing phase III clinical trials for the T2DM indication. Drug has the potential to delay the disease progression or even eliminating late-stage complications.
ORMD-0801 (Oral insulin) Capsule, with enhanced patient compliance, is currently undergoing phase III clinical trials for the T2DM indication. Drug has the potential to delay the disease progression or even eliminating late-stage complications.
Article presents results of 12-week multicenter, randomized, placebo-controlled trial assessing safety and efficacy of multiple active doses of ORMD-0801 in patients with T2DM on chronic background therapy with Metformin or combination oral therapy.
The trial demonstrated that ORMD-0801, an oral insulin candidate, was safe and well tolerated at 8 mg twice daily dosing, meeting the primary endpoint of no difference in adverse events for ORMD-0801 compared to placebo.
The agreement grants Medicox an exclusive license to apply for regulatory approval for and distribute Oramed's oral insulin candidate, ORMD-0801, for ten years in the Republic of Korea.
Oramed is seeking to transform the treatment of diabetes through its proprietary lead candidate, ORMD-0801, which is being evaluated in two pivotal Phase 3 trials and has the potential to be the first commercial oral insulin capsule for the treatment of diabetes.
Oravax's oral Covid-19 vaccine candidate is designed using D-Crypt™ technology as a triple antigen VLP vaccine that targets three major surface proteins of the SARS-CoV-2 virus - Spike, Membrane and Envelope.
The 12-week trial enrolled 32 patients (with 30 patients completing) and demonstrated that ORMD-0801 (insulin) was safe and well tolerated at 8 mg twice daily dosing, meeting the primary endpoint of no difference in adverse events for ORMD-0801 compared to placebo.
Primary endpoint of trial is to compare efficacy of ORMD-0801 (Insulin) to placebo in improving glycemic control by A1c over a 26-week treatment period, with a secondary endpoint of comparing ORMD-0801 to placebo in maintaining glycemic control over a 52-week treatment period.
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