Tag Archives: ORMD-0801

Novo STEP 4 Sema Obesity Results @ ENDO 2021; Oramed Second Oral Insulin Ph3 Trial Update; Dexcom Promotes Jereme Sylvain to CFO; vTv Granted New Patent for TTP399

A series of diabetes-related news items have been observed: Novo Nordisk presented results from the STEP 4 semaglutide 2.4mg obesity trial at the ENDO 2021 conference (view press release); Oramed announced it has screened the first patients in its second oral insulin Ph3 trial; Dexcom has promoted Jereme Sylvain to CFO, allowing Quentin Blackford to take over Steve Pacelli’s responsibilities for strategy and corporate development (view press release); and vTv announced the USPTO issued patent 10,952,993 protecting methods of treatment using TTP399, a novel GKA. Below, FENIX provides highlights and insights from the respective news items, including updated perspective on Oramed’s potential regulatory timeline.

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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Oramed Randomizes First Patients in Ph3 Oral Insulin Trial; Dario Hires New Employer Sales Lead

Two diabetes-related news items have been observed: Oramed has begun randomizing patients into its Ph3 ORMD-0801 T2DM study (view press release) and Dario announced the hiring of Chris Chan as the company’s new SVP of employer sales (view press release). Below, FENIX provides highlights and insights from the respective news items.

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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Purchase Blast$599.00

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Medtronic CY Q3 ’20 (FY Q2 ’21) Earnings Update; Dario Signs New Deal with Fortune 500 Company; Oramed Screens First Patients in the Ph3 ORMD-0801 Trial

A series of diabetes-related news items have been observed: Medtronic hosted its CY Q3 ’20 (FY Q2 ’21) earnings call (press release; slides); Dario signed a deal with a Fortune 500 company (press release); and Oramed announced it has screened the first patients in its Ph3 oral insulin (ORMD-0801) trial. Below, FENIX provides highlights and insights from the respective news items.

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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Purchase Blast$599.00

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Oramed Ph3 Oral Insulin Program Initiated; Filing Timeline Unclear

A CT.gov record for Oramed’s first oral insulin (ORMD-0801) Ph3 trial has been observed. Recall, Oramed recently announced it had come to an agreement with FDA on the Ph3 program design, which will include two 26-week Ph3 trials in 1,125 adult T2DM patients (previous FENIX insight). The second Ph3 study has not yet been observed on CT.gov. Below, FENIX provides additional trial details, insight into the puzzling primary completion date, and thoughts on why the ORMD-0801 filing timeline may be different between the US and Europe.

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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Purchase Blast$599.00

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DAPA-HF Receives Positive CHMP Opinion; Oramed Oral Insulin Ph3 T2DM Development Update; Livongo Partners with GuideWell

Three diabetes-related news items have been observed: DAPA-HF received a positive CHMP opinion (view here); Oramed announced it has come to an agreement with FDA regarding the Ph3 T2DM program design for its oral insulin (ORMD-0801), with the company planning to initiate the trials in Q4 ’20; and Livongo has partnered with Guidewell (Florida Blue) to expand access to Livongo’s Diabetes platform in Florida. As of this publication, an AstraZeneca press release regarding the DAPA-HF CHMP opinion has not been observed. Below, FENIX provide highlights and insights for the respective news items.

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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Purchase Blast$599.00

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New Novo QW Insulin Icodec Data; Novo Updates Rybelsus Website; Dexcom G6 VA Pharmacy Distribution; Ascensia Partners to Accelerate Data Strategy; REWIND Canada Approval; Oramed ORMD-0801 NASH Data; EASD 2020 Key Press Releases (Sept 22)

On Day 2 of EASD, five key press releases and news items were observed from Novo Nordisk, Dexcom, Ascensia, Lilly, and Oramed. Below FENIX provides insights and context from each respective announcement.

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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Purchase Blast$599.00

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Oramed Oral Insulin End-of-Ph2 FDA Meeting Provides Ph3 Development Clarity

Oramed announced it had a positive end-of-Ph2 meeting with FDA for its oral insulin (ORMD-0801). Following the meeting, Oramed said it plans to initiate two concurrent Ph3 trials. The company did not provide an updated timeline for Ph3 trial initiation, but it previously indicated the trials would begin in Q3 ’20 (previous FENIX insight). Below, FENIX provides brief thoughts on the Oramed news, including readthrough to Biocon’s oral insulin tregopil.

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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Purchase Blast$599.00

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Dapa Reduces Progression to T2DM; Teplizumab Continues to Delay T1DM Onset; Arecor AT247 Faster than Fiasp; ADA Key Press Releases (June 15)

Today, twelve diabetes-related news items were observed: DAPA-HF delays T2DM onset, teplizumab follow-up results, Arecor uRAI Ph1 data, new Afrezza practical data, Diasome HDV Ph2 results, Hua Medicine Ph3 GKA data, ORMD-0801 in NASH, Glytec CGM POC data, Biolinq’s first-in-human CGM data, and more. Below, FENIX provides context and analysis for the announcements.

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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Purchase Blast$599.00

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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).

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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Purchase Blast$599.00

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

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.

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.