Category Archives: Dual/triple agonist

Empa T1DM Filed with FDA; Oral GLP-1RA Advanced to Ph1; Lilly Q2 ’19 Earnings Update

Lilly hosted its Q2 ’19 earnings call and provided updates across its diabetes business. Of note, Lilly’s pipeline now lists empa T1DM as being filed (FDA refused to accept the initial sNDA). Following the 36-week results from Lilly’s AWARD-11 study, Lilly said it plans to file high-dose Trulicity with regulatory authorities “by late 2019.” Furthermore, Lilly’s oral GLP-1RA, called “GLP-1 NPA” (GLP-1 non-peptide agonist), has advanced to Ph1. Below, FENIX provides diabetes-related highlights and insights from the call, including the assumption that the REWIND CHMP agenda listing for July was only for adoption of supplementary information.

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Janssen-Hanmi Ends Ph2 Dual Agonist; Sanofi Efpeg Deal Restructured

Recently, there have been two seemingly interrelated announcements from Hanmi regarding the termination of their GLP-1/GCG dual agonist partnership with Janssen and a restructuring of the deal with Sanofi for efpeglenatide. Below, FENIX provides a summary of these news items and potential read-through.

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Sanofi R&D Re-focusing; R&D Layoffs in France and Germany

According to Reuters, Sanofi is set to layoff 466 R&D-related jobs as part of an initiative to prioritize oncology, immunology, rare diseases, and vaccines while at the same time limiting internal CV R&D to its current pipeline. Furthermore, Sanofi is said to maintain the support of its diabetes and CV programs through its partners. Below, FENIX provides thoughts on the Sanofi R&D re-focusing in the context of the company’s CV/Met pipeline and recent senior management changes.

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New Tirzepatide vs. Ozempic H2H Ph3 Trial (SURPASS-2)

Lilly initiated its Ph3 tirzepatide vs. Ozempic H2H study (SURPASS-2) which is the 4th tirzepatide pivotal trial (not including Japan). The final pivotal trial, SURPASS-5 (add-on to basal insulin), is projected to initiate shortly. Below, FENIX provides an overview of SURPASS-2 as well as insight into the curious observation that the trial does not specify which dose of Ozempic is being used (0.5 or 1.0mg). 

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ADA 2019 Key Press Releases (June 9 and 10)

14 major news items were observed over the past 2 days including Provention Bio’s teplizumab, dasiglucagon pivotal data, DECLARE and EMPA-REG subanalyses, Afrezza pediatric and fixed titration data, Tandem and Insulet hybrid-closed loop data, and more. Below, FENIX provides context and analysis for the announcements.

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Lilly REWIND and Tirzepatide Comments From ADA 2019 Investor Call

Lilly hosted its annual ADA 2019 investors call where senior management primarily discussed the REWIND CVOT readout and tirzepatide T2DM Ph2 results. Additionally, Lilly provided an overview and timeline for its Ph3 tirzepatide obesity program (SURMOUNT) and Ph2 tirzepatide NASH program (SYNERGY-NASH). Below, FENIX provides key commentary and insights from the call.

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Novo ADA 2019 Investor Event Highlights

Novo Nordisk hosted its ADA 2019 investor event immediately following the data readout from Lilly’s REWIND CVOT. Unsurprisingly, Novo compared REWIND to LEADER and SUSTAIN 6. Of note, Novo disclosed plans to initiate its high-dose semaglutide study, SUSTAIN FORTE, in Q2 ‘19. Other topics covered during the call include semaglutide LCM, commentary on Lilly’s tirzepatide, connected pen data, QW basal insulin (LAI287), and more. Below, FENIX provides insights and highlights from the call.

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New Tirzepatide vs. Semaglutide Ph1 T2DM Clamp Study; Ph3 SURPASS-1 Monotherapy Trial Initiated

Lilly recently initiated two new tirzepatide T2DM studies. The first is a Ph1 clamp study comparing tirzepatide to Novo’s QW injectable semaglutide, and the second is the Ph3 SURPASS-1 monotheraphy trial vs. pbo. Interestingly, the Ph1 trial is evaluating the effect of tirzepatide on α and β cell function. Below, FENIX provides thoughts on both studies including Lilly’s potential rationale for the H2H clamp trial as well as insight as to why SURPASS-1 is longer than Novo’s Ph3 semaglutide monotherapy trial.

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Zealand Q1 ’19 Earnings Update

Zealand hosted its Q1 ’19 earnings call and provided updates to its diabetes business including dasiglucagon (hypoglycemia rescue, congenital hyperinsulinism, and bi-hormonal closed-loop) and its GLP-1/GCG dual agonist with Boehringer Ingelheim. Recall, Zealand recently disclosed that its dasiglucagon hypoglycemia rescue filing has been delayed to early 2020. Below, FENIX provides highlights and insights from the call.

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