Category Archives: Dual/triple agonist

Payback for Lilly as Tirzepatide Beats Ozempic in Ph3 SURPASS-2 H2H Trial

Lilly announced positive topline results from the H2H Ph3 SURPASS-2 trial comparing tirzepatide to 1.0 mg Ozempic in patients with T2DM.  Lilly’s CSO provided further commentary on tirzepatide and SURPASS-2 during the 2021 Cowen Health Care Conference. According to the press release, the 15mg tirzepatide dose reduced A1C by -2.46% and weight by -12.4kg in the SURPASS-2 trial. Further, the lowest dose of tirzepatide (5mg) reduced A1C by -2.09% and body weight by -7.8kg compared to 1.0mg injectable semaglutide at -1.86% and -6.2kg. Full results from SURPASS-2 are scheduled to be presented at ADA 2021 (June 25-29). Below, FENIX provides an overview of the topline SURPASS data, what tirzepatide list pricing could be, Novo’s potential counter-message, and a summary of Lilly management commentary from today at Cowen.

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DAPA-CKD filed with EMA; February 22-25 CHMP Agenda; G&L Partners with IDF

A series of cardiometabolic-related news items have been observed: the CHMP agenda for this month’s meeting (February 22-25, 2021) has been released, and it includes one notable item: DAPA-CKD appears for the first time; and Gan & Lee announced a new partnership with IDF. Below, FENIX provides highlights and insights from the respective news items.

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Tirzepatide Continues to Perform; Positive Ph3 SURPASS-3 and SURPASS-5 Topline Results

Lilly announced positive topline results from the Ph3 SURPASS-3 (vs. degludec) and SURPASS-5 (add-on to glargine U100) trials evaluating the safety and efficacy of three tirzepatide doses (5mg/10mg/15mg). Recall, Lilly announced results from the first Ph3 tirzepatide study, SURPASS-1 (tirzep in treatment-naive patients), in December 2020. According to the press release, the 15mg dose of tirzepatide reduced A1C by -2.4% and weight by -12.9kg in the SURPASS-3 trial. In SURPASS-5, patients observed an average A1C reduction of -2.6% and weight loss of -10.9kg. Full results from SURPASS-3 and SURPASS-5 are scheduled to be presented at ADA 2021 (June 25-29). Below, FENIX provides an overview of the topline SURPASS data as well as updated thoughts on the tirzepatide market impact.

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Novo to Initiate Oral Sema Alzheimer’s Ph3 Program; Novo Ph3 High-dose Rybelsus Trial in 2021; Lilly to Initiate Tirzepatide HFpEF Trial; Highmark and BI Announce Jardiance OBC Results; Medtronic’s Sean Salmon Takes on CV Responsibilities; + Five Other News Items

A series of diabetes-related news items have recently been observed from Novo Nordisk, Lilly, BI/Highmark, Medtronic, Diamyd, Provention Bio, Zealand, and Sensyne Health. Below, FENIX provides highlights and insights for the respective news items.

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Lilly Ph3 Tirzepatide SUPRASS-1 Data Lives up to Ph2b Hype

Lilly announced topline results from the first tirzepatide Ph3 study, SURPASS-1. The study demonstrated up to a -2.1% reduction in A1C and -9.5kg weight loss with 15mg tirzepatide, according to the trial product estimand (e.g. per-protocol analysis). Full results from the SURPASS-1 trial are scheduled to be presented at the ADA 2021 conference (June 25-29). Of note, Lilly has also recently initiated three additional Ph3 studies in the tirzepatide obesity program (SURMOUNT 2, 3, and 4). Below, FENIX provides a SURPASS-1 comparative analysis, including thoughts on tirzepatide in the context of high-dose Ozempic, high-dose Rybelsus, and high-dose Trulicity.

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AZ, Provention Bio, Teva, and BD Q3 ’20 Earnings Updates

AstraZeneca (press release; slides), Provention Bio (press release), Teva (press release; slides), and Becton Dickinson (press release) hosted their respective Q3 ’20 earnings calls. Below, FENIX provides diabetes-related highlights and insights from the calls, including insight into AZ’s curious move to advance the development of its PCSK9i mAb.

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Lilly, Novartis, Pfizer, and Merck Q3 ’20 Earnings Updates

Lilly, Novartis, Pfizer, and Merck each hosted their respective Q3 ’20 earnings calls and provided updates across a variety of topics. Importantly, it was disclosed that FDA has requested an advisory committee meeting to discuss Novartis’s Entresto PARAGON-HF submission. Below, FENIX provides highlights and insights from the respective earnings calls.

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Lilly’s Next-gen Tirzepatide for Oral Delivery? New Lilly GIP/GLP Dual Agonist Ph1 Studies

Two new Ph1 trials for Lilly’s LY3493269 GIP/GLP dual agonist have been observed on CT.gov (NCT04515576 and NCT04498390). Interestingly, the two trials are separately evaluating subcutaneous and oral administration of LY3493269. LY3493269 is believed to be a different molecule than tirzepatide (LY3298176) since it has a different LY number. Below, FENIX provides an overview of the studies as well as thoughts on why Lilly may have had to develop a next-gen tirzepatide for oral delivery.

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Novo Q2 ’20 Roadshow; Provention Bio Q2 ’20 Earnings Update; Senseonics Eversense Covered by Highmark

Novo Nordisk hosted its post-Q2 ’20 earnings roadshow event (see previous FENIX insight on Q2 ’20 Novo earnings from August 6). Additionally, Provention Bio hosted its Q2 ’20 earnings call yesterday (press release), and Senseonics announced a positive coverage decision for its implantable CGM from Highmark. Below, FENIX provides highlights and insights from the respective news item and earnings calls.

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Merck In-licenses Hanmi’s Dual Agonist for NASH; Generic Empagliflozin Tentative Approval

Two diabetes-related news items have been observed: Merck announced it has entered into an exclusive licensing agreement with Hanmi for the development and commercialization of efinopegdutide, a QW GLP-1/glucagon dual agonist for the treatment of NASH (formerly HM12425A and JNJ-64565111) and Lupin received tentative FDA approval for its generic empagliflozin (view article). Below, FENIX provides thoughts on why Merck has Janssen and Novo to thank for the favorable deal terms.

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