Tag Archives: LXRX

CORRECTING AND REPLACING: Empa T1DM 2.5mg Safe; 1 Death at High Dose; Paul Strumph no longer with Lexicon

Today at the EASD 2018 conference, BI/Lilly presented data from the Ph3 EASE-2 and EASE-3 empagliflozin T1DM studies along with simultaneous publication in Diabetes Care. Results demonstrated slightly greater reductions in A1C compared to the sotagliflozin and dapagliflozin Ph3 studies; however, there was one death from DKA in a patient on 25mg empagliflozin. Details about the death are described in the EASE Ph3 publication supplementary appendix. Below, FENIX provides a curious press release observation, a winners & losers analysis, and a comparative DKA SGLTi analysis and overview of the EASE-2 and EASE-3 results.

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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Lexicon Q2 ’18 Earnings Update

Lexicon hosted its Q2 ’18 earnings call and provided updates on sotagliflozin. Discussion centered on the potential FDA adcom for sotagliflozin in T1DM, DKA consensus guidelines being developed by ATTD, and the benefit of sotagliflozin in reducing hypoglycemia.

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.

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

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.

FENIX Analysis: SGLT2i HF CVOTs and Stopping Early Scenarios

Currently, there are multiple ongoing, label-enabling HF CVOTs in the SGLT2i class for Jardiance, Farxiga, and Zynquista (sotagliflozin), along with other studies exploring surrogate endpoints, biomarkers, and mechanisms of action. FENIX has created a tale-of-the-tape summary of the SGLT2i HF CVOTs along with a projected timeline for filings and launches. In summary, it is believed that AZ’s DAPA-HF CVOT has a high probability of stopping early for overwhelming efficacy and thus creating a priority review scenario to leap AZ ahead of BI/LLY by 6-12 months in this important LCM opportunity. Below is a summary of the rationale and hypothesis comparing the different development approaches by SGLT2i sponsors to improve clinical outcomes in HF patients.

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.

Lexicon Hosts R&D Day

Lexicon hosted its R&D Day and provided an overview of clinical and regulatory activities for its diabetes portfolio including sotagliflozin and LX2761 (selective SGLT1i). Below, FENIX provides highlights of the R&D day as well as thoughts on the impact of sotagliflozin on the T1DM and T2DM markets.

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.

JPM Day 2: Sanofi, Lilly, Lexicon, Dexcom and more

During Day 2 of JPM, presentations ranged across both diabetes drug (Sanofi, Lilly, Lexicon, and Mylan) and device manufacturers (Dexcom, Insulet, and Roche), although Mylan and Roche did not discuss their diabetes portfolios. Below, find key takeaways from JPM followed by more in-depth coverage.

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.

Lexicon Q4 ’17 Earnings Update

Lexicon hosted its Q4 ’17 earnings call and provided updates on its T1DM and T2DM sotagliflozin development programs. Interestingly, Lexicon disclosed they plan to file sotagliflozin in T1DM in the US and EU in the coming weeks, which is more specific than previously projected (H1 ’18).

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.

Sotagliflozin T2DM renal Ph3 studies initiated by Sanofi

Two new Sanofi-sponsored clinical trial records for sotagliflozin, SOTA-CKD3 and SOTA-CKD4 have been observed. The aim of the studies is to demonstrate that sotagliflozin provides superior A1C reductions in patients with T2DM and renal impairment (stage 3 and stage 4) compared to placebo.

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.

Lexicon announces additional Ph3 sotagliflozin results in T1DM

Lexicon has announced additional positive data from the Ph3 inTandem1 study. Of note, a slight increase in DKA was seen in the sotagliflozin groups during the extension period with 6 cases (2.5%) on 200mg and 3 cases (1.3%) for 400mg compared to 1 patient (0.4%) on placebo.

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.