Tag Archives: Data

BI/LLY Ph3 EASE Update – Jardiance in T1DM

Today, BI/Lilly announced positive top-line results for their two Ph3 trials in T1DM, EASE-2 and EASE-3, but they did not provide specific data results in their press release. Curiously enough, Tuesday’s ADA morning session will not be results from the Ph3 EASE trials as BI/LLY said full results from both trials will be at EASD on October 4, 2018. DKA with empa 2.5mg was “comparable to placebo”, and empa 10mg and 25mg DKA rates were “higher than placebo.” BI/LLY said regulatory options are being explored.

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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ADA ’18 Key Data Press Releases (June 24)

4 major press releases featuring new data presented at ADA ’18 were observed across diabetes drugs and devices. Below, FENIX has provided context and analysis of these 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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Imbalance in DKA Observed in DEPICT-2; Full 52-week inTandem1 data

AZ presented 24-week data from the second Ph3 study (DEPICT-2) evaluating dapagliflozin in T1DM patients, showing an imbalance in DKA compared to placebo. Additionally, Lexicon presented 52-week data of the Ph3 inTandem1 study of sotagliflozin in T1DM.

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 CVOT strategy; ADA ’18 Analyst Briefing

Novo hosted its annual ADA analyst briefing (presentation slides), predominantly discussing oral semaglutide. Of note, Novo disclosed they are no longer conducting a large-scale CVOT for Ozempic (formerly SOUL), instead leveraging the results of both SUSTAIN 6 and PIONEER 6 between injectable and oral semaglutide. Novo senior management said they believe it will be difficult for PIONEER 6 to demonstrate CV benefit at p < 0.05 given the low number of pre-specified events will require a large reduction in the hazard ratio. Additionally, Novo stated they plan to file oral semaglutide in mid-2019. Below are highlights from the ADA analyst event including three potential scenarios for injectable and oral semaglutide CV indications.

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

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Devices/Apps ADA ’18 Key Data Press Releases (June 23)

As a follow-up to our drug analysis of 14 press releases, FENIX has provided context and analysis for 7 device and app-related 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.

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.

Drug ADA ‘18 Key Data Press Releases (June 23)

21 major press releases featuring new data presented at ADA ’18 were observed across diabetes drugs, devices, and apps, a major increase from 9 on the first day of ADA ‘17. Below, FENIX has provided context and analysis for 14 drug-related announcements, with analysis of device and app-related announcements to follow in a separate alert.

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.

Novo Suspends Ph1 Stable Glucagon Analog Study

The CT.gov record for Novo’s Ph1 stable glucagon analog study (NN9030) has been updated, and the trial is now listed as “Suspended (Evaluation of data).” Below, FENIX provides potential scenarios for the recruitment suspension.

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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Novo’s Oral Semaglutide Beats Victoza and Januvia

Novo Nordisk has announced topline results from the Ph3 PIONEER 4 (vs. 1.8mg Victoza) and PIONEER 7 (3, 7, and 14 mg oral sema dose escalation vs. Januvia) studies. Both trials met their primary outcomes (non-inferiority to Victoza and superiority to Januvia), and oral semaglutide also demonstrated statistically significant A1C and weight reduction vs. Victoza. Additionally, FENIX provides insight into a potential relationship between PIONEER 7 dose escalation and discontinuation rates observed in the reported PIONEER studies.

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.

GlySens Implantable CGM Trial Completed

The FIGS-2 trial for GlySens’s implantable CGM, Eclipse, has completed according toCT.gov- two and a half years after the originally scheduled completion date of December 2015. The primary endpoint of the 20-subject study was adverse events. FENIX has conducted a headwinds/tailwinds analysis of the Eclipse system in the context of the larger CGM market.

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.

New Fiasp/Medtronic 670G Study on CT.gov

A CT.gov record for a study evaluating Novo’s Fiasp (faster-acting insulin aspart) in a Medtronic 670G pump has been observed. This Ph4 study is sponsored by Bruce Buckingham’s lab at Stanford, and Medtronic is listed as a collaborator (Novo is not believed to be part of the study). Recall, the Fiasp label does not include designation for use in insulin pumps. Below, FENIX provides insight into the use of ultra-rapid-acting insulin in pumps as well as why a future commercial partnership between Novo and Medtronic could make sense.

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.