Category Archives: Topics

Zealand Q3 ’19 Earnings Update; Ph2 dual agonist trial details revealed

Zealand hosted its Q3 ’19 earnings call and provided updates to its diabetes business including dasiglucagon and its GLP-1/GCG dual agonist with Boehringer Ingelheim. Recall, Zealand recently completed the Ph3 pediatric program for the dasiglucagon HypoPal, which clears the way for NDA submission in Q1 ’20. Below, FENIX provides highlights and insights from the call.

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Livongo for Hypertension Demonstrates BP Benefit at 4 and 12 Weeks

Livongo announced results from a 12-week study evaluating the impact of its Livongo for Hypertension program. Full results from the study will be presented at the AHA conference on November 16, 2019. Below, FENIX provides brief thoughts on the new Livongo data.

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AZ Initiates Unbranded HF Education Campaign

AstraZeneca announced the initiation of a new unbranded disease state education (DSE) campaign called “Diabetes Can Break Your Heart,” which focuses on heart failure (HF) risk in patients with T2DM. The DSE includes a new website as well as a national bus tour that will stop at select cities throughout 2020 but starts in Philadelphia at the upcoming AHA conference (November 16-18). Below, FENIX provides insights about the new AZ HF campaign including a comparison to BI/Lilly’s initial Jardiance DSE for its CV death risk reduction indication.

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Empa T1DM FDA Adcom Overwhelmingly Negative (2-14); Is SGLTi in T1DM Approvable in the US?

Today, FDA held an advisory committee meeting to discuss the benefit/risk profile of 2.5mg empagliflozin for the treatment of T1DM. Somewhat surprisingly, the panel voted overwhelmingly against (2-14) the approval of 2.5mg empa based on the currently characterized benefit/risk profile and small amount of supporting data. BI/Lilly subsequently issued a press release regarding the outcome of the adcom. Below, FENIX provides insight into the future of SGLTi therapy in T1DM including implications to BI/Lilly, AZ, and Lexicon.

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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.

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Senseonics Q3 ’19 Earnings Update

Senseonics hosted its Q3 ’19 earnings call (press release) and provided updates to its Eversense implantable CGM commercial and pipeline activities. Separately, Senseonics also announced Medicare has finalized a payment rate for Eversense through Medicare Part B. Below, FENIX provides highlights and insights from the call.

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BI/Lilly Initiate Jardiance Acute HF Study (EMPULSE)

BI/Lilly announced the initiation of a new Jardiance study (EMPULSE) in T2DM and non-T2DM patients who have been hospitalized for acute heart failure. Below, FENIX provides an overview of the trial as well as insights into how the EMPULSE trial appears to be a natural progression of BI/Lilly’s Jardiance LCM strategy.

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Empa T1DM Adcom Could Be Easier Than Sota, But Still Difficult; Briefing Documents Analysis

Briefing documents for the BI/Lilly empagliflozin T1DM FDA adcom were posted today in advance of the November 13, 2019 meeting. Interestingly, BI/Lilly is only pursuing approval for the low, 2.5mg dose of empagliflozin, which demonstrated less DKA but also lower efficacy. Questions around the 2.5mg dose and its limited clinical data are likely to be the center of the adcom discussion. Below, FENIX provides thoughts on the empa T1DM adcom including analysis of the benefit/risk ratio, proposed risk mitigation strategy, and adcom panelists (9 of whom were also on the sota adcom).

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Patient Dies on t:slim X2 with Basal IQ; Tandem Denies Involvement

A report has been published on the FDA MAUDE database indicating a patient using Tandem’s t:slim X2 insulin pump with Basal IQ technology passed away on October 3, 2019. However, in an emailed statement to media outlets, Tandem said the t:slim X2 pump with Basal IQ was not involved in the patient’s death. Below, FENIX provides context and insight related to this news including potential read-through to the impending Control IQ approval.

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Lexicon Disputes Sota CRL with FDA; Lexicon and Xeris Q3 ’19 Earnings Updates; Dexcom +30% Today

Lexicon hosted its Q3 ’19 earnings call and provided an update on the sotagliflozin T1DM regulatory situation as well as the T2DM Ph3 development program. Of note, Lexicon disclosed it has disputed the sota T1DM CRL with the Office of New Drugs, and it is awaiting a decision shortly. Additionally, Xeris released its Q3 ’19 earnings, and Dexcom stock has jumped +30% following its earnings beat. Below, FENIX provides insights on the sotagliflozin dispute including analysis of Peter Stein’s involvement in the Office of New Drugs review.

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