Category Archives: Dual/triple agonist

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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Dapa Reduces Progression to T2DM; Teplizumab Continues to Delay T1DM Onset; Arecor AT247 Faster than Fiasp; ADA Key Press Releases (June 15)

Today, twelve diabetes-related news items were observed: DAPA-HF delays T2DM onset, teplizumab follow-up results, Arecor uRAI Ph1 data, new Afrezza practical data, Diasome HDV Ph2 results, Hua Medicine Ph3 GKA data, ORMD-0801 in NASH, Glytec CGM POC data, Biolinq’s first-in-human CGM data, and more. Below, FENIX provides context and analysis for the announcements.

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Tirzepatide CVOT Underway; Dexcom G6 CE Mark for Wear on Upper Arm; Nemaura Medical to Join Russell Indices

A series of diabetes-related news has been observed: Lilly announced it has dosed the first patient in the tirzepatide SURPASS-CVOT study, Dexcom received CE Mark for the G6 CGM to be worn on the back of the upper arm, and Nemaura Medical is set to join the Russell 2000 Index and Russell 3000 Index. Below, FENIX provides highlights and insights from the respective news items.

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