Category Archives: SGLT2i

Ertugliflozin Fails to Demonstrate CV Benefit; Merck and Pfizer Q1 ’20 Earnings Updates

Merck and Pfizer hosted their respective Q1 ’20 earnings calls and provided updates to their diabetes businesses. Importantly, Merck disclosed that the VERTIS CV outcomes trial failed to meet superiority for CV protection. Full results from VERTIS CV are scheduled to be presented during the virtual ADA conference on June 16 at 11:15 AM ET. Below, FENIX provides highlights and insights from the respective earnings calls including thoughts on the surprising VERTIS CV results.

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Lexicon to Focus on Sota T1DM and Deprioritize T2DM; Lexicon Q1 ’20 Earnings Update

Lexicon hosted its Q1 ’20 earnings call and provided updates to the sotagliflozin business, including plans to focus on the sotagliflozin T1DM indication rather than T2DM. Recall, in March 2020 Lexicon announced the close out of the SCORED and SOLOIST outcomes studies due to COVID-19 as well as the low near-term prospect of finding a commercialization partner (previous FENIX insight). Below, FENIX provides highlights and insights from the call.

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Empa T1DM Discontinued; Lilly Q1 ’20 Earnings Update; AZ Initiates Farxiga COVID-19 Trial

Lilly hosted its Q1 ’20 earnings call and provided updates to its diabetes business. Of note, Lilly disclosed that the empa T1DM program has been discontinued. Separately, AstraZeneca announced plans to evaluate Farxiga as a treatment for hospitalized COVID-19 patients who are at increased risk of complications, such as organ failure. The trial is being conducted at Saint Luke’s Mid America Heart Institute and led by Mikhail Kosiborod. Below, FENIX provides highlights and insights from the Lilly earnings call as well as thoughts on the new AZ trial.

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J&J Q1 ’20 Earnings Update

Johnson & Johnson hosted their Q1 ’20 earnings call and briefly touched on the Invokana franchise. Unsurprisingly, much of the call was focused on the impact of COVID-19, which led J&J to lower its 2020 guidance. Below, FENIX provides diabetes-related highlights and insight from the call.

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DAPA-CKD Stopped Early for Overwhelming Efficacy

AstraZeneca announced that an independent data monitoring committee (DMC) has recommended stopping the DAPA-CKD study early due to overwhelming efficacy. According to CT.gov, the early trial closeout is ~8 months ahead of the full trial completion date (initially scheduled to complete in November 2020). Below, FENIX provides thoughts on DAPA-CKD in the context of Janssen’s CREDENCE, which was also stopped early, as well as potential read through to BI/Lilly and Lexicon.

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CRL for Empa 2.5mg in T1DM

BI/Lilly announced late Friday that the FDA has issued a CRL for the T1DM sNDA of empagliflozin 2.5 mg (press release). Of note, the CRL indicates that “the FDA is unable to approve the application in its current form.” Below, FENIX provides thoughts on the empa T1DM CRL in the context of other SGLTi T1DM initiatives.

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Thoughts on Lexicon Closing Its Sota CVOTs

Yesterday, Lexicon announced the early close out of its sotagliflozin CVOTs, SCORED and SOLOIST, mainly due to operational challenges with COVID-19 and the low likelihood of finding a commercialization partner (press release). Below, FENIX provides highlights and insights surrounding this update, including the potential generalization to BI/Lilly’s EMPEROR HF studies, and larger thoughts on Lexicon’s pivot away from sotagliflozin.

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Zyquista T1DM CRL stands (Lexicon Q4 ’19 Earnings Update); Jardiance CKD Fast Track Designation

Lexicon hosted its Q4 ’19 earnings call (press release) and provided brief updates on the Zyquista T1DM CRL appeal as well as the T2DM Ph3 development program. Additionally, Lilly announced the FDA’s fast track designation to Jardiance in chronic kidney disease (press release). Of note, CDER reaffirmed the FDA’s decision on the Zyquista T1DM CRL, stating the NDA application in T1DM could not be approved in its current form. Below are the key highlights and insights from Lexicon’s earnings call as well as the Jardiance CKD fast track designation, especially in the context of other ongoing renal outcomes trials.

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New dapa HF study (DICTATE-AHF) in T2DM patients with acute decompensated heart failure

Last week, a Ph3 dapagliflozin trial (DICTATE-AHF) in T2DM patients with acute decompensated heart failure (ADHF) was observed on CT.gov. Of note, the study is assessing the decongesting effects of dapagliflozin and protocolized diuretic therapy in ADHF patients. Below, FENIX provides thoughts on this new trial in the context of other SGLT2 HF trials and what it could mean for AZ.

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