Category Archives: Dual/triple agonist

Novo Dual Agonist T2DM Intentions Disclosed at ADA Investor Event; Lilly Could Pursue Hypo Claim vs. Degludec in QW Basal Ph3

Two cardiometabolic presentations from Novo Nordisk and Lilly have recently been observed: Novo hosted an ADA investor event and Lilly presented CGM data from the Ph2 QW insulin trial at ADA 2021. Below, FENIX provides insight on what Novo really hopes to accomplish vs. tirzepatide, and how Lilly may pursue a hypo reduction claim vs. degludec for its QW basal insulin.

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ADA 2021 Key Press Releases (June 25)

On the first day of ADA 2021, eleven cardiometabolic-related news items were observed from Medtronic, Lilly, AstraZeneca, CeQur, Abbott, Onduo, Glooko, Mannkind, ViaCyte, Glytec, and Akero. Below, FENIX provides context and analysis for the announcements.

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Bigfoot Unity and Zegalogue RTU Dasiglucagon Now Available in the US; Carmot Initiates GIP/GLP Trial in Obesity and T2DM; Dexcom Launches TIR Educational Campaign; Dario Selected as Digital Health Provider for Coastal Family Health Center

Ahead of the 2021 ADA conference (June 25-29), a series of cardiometabolic-related news items have been observed: Bigfoot announced the Bigfoot Unity connected system is now available in select markets across the US; Zealand announced US commercial availability of its dasiglucagon hypoglycemia product, Zegalogue; Carmot Therapeutics announced initiation of a Ph1 trial evaluating a QW dual GLP-1/GIP RA, CT-388; Dexcom announced the launch of an awareness and educational campaign called The Global Movement for Time in Range; and Dario Health announced it was selected as a digital health provider for Coastal Family Health Center. Below, FENIX provides highlights and insights for the respective news items.

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Lilly Obesity Ph2 GGG Tri-agonist Trial; Novo QW Icodec Ph3 T2DM; Sigilon Q1 ’21 Earnings Update

A series of cardiometabolic-related news items have been observed: a CT.gov record for a Ph2 Lilly-sponsored trial investigating QW LY3437943 (GGG tri-agonist) in obesity has been observed; a CT.gov record for Novo Nordisk’s Ph3 QW insulin icodec T2DM trial (ONWARDS 4) has been observed; and Sigilon announced its Q1 ’21 earnings, though it did not provide a development update on SIG-002 nor did it host an associated webcast. Below, FENIX provides highlights and insights for the respective news items.

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Lilly and Novartis Q1 ’21 Earnings Updates; New Trulicity TV DTC; Provention Meets with FDA

A series of cardiometabolic-related news items have been observed: Lilly and Novartis hosted their respective Q1 ’21 earnings calls; Lilly has initiated a new Trulicity DTC campaign; and Provention Bio announced it met with FDA on April 23, 2021 to discuss the ongoing teplizumab PK comparability issue. Importantly, Lilly disclosed that SURPASS-4 has accrued all of its pre-specified CV events and the trial is scheduled to close out in May with topline results expected by the end of Q2 ’21. Recall, Lilly has previously stated SURPASS 4 is the gating factor for tirzepatide T2DM global regulatory submissions later in 2021. Below, FENIX provides highlights and insights for the respective items.

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Heart Failure: Tirzepatide vs. Semaglutide HFpEF Ph3 Trial Analysis

Lilly has recently initiated the Ph3 tirzepatide HFpEF trial, called SUMMIT (view CT.gov record). Recall, during Lilly’s 2021 guidance call (December 15, 2020), Lilly first disclosed plans to develop tirzepatide for the treatment of HFpEF (previous FENIX insight). Below, FENIX provides an overview of SUMMIT, including a comparative analysis with Novo’s semaglutide HFpEF trial (STEP HFpEF).

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New BI/Zealand Trials in NASH and Obesity; vTv Granted BTD for TTP399; Jaguar Gene Therapy $139M Series B; CeQur $115M Series C5; Nemaura Launches BEATdiabetes App and proBEAT CGM Pilot; BioCorp/Roche Launch Mallya in France; Amarin CEO to Retire

A series of cardiometabolic-related new items have recently been observed from Boehringer Ingelheim/Zealand, vTv Therapeutics, Jaguar Gene Therapy, CeQur, Nemaura Medical, Biocorp/Roche, and Amarin. Below, FENIX provides highlights and insights for the respective news items.

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Meet AZ Management Investor Event Highlights

AstraZeneca hosted its virtual Meet AZ BioPharmaceuticals Management investor event (view slides) in which it provided updates across its business, including CVRM near-term opportunities (view slides) and its emerging pipeline (view slides). Below, FENIX provides highlights and insights from the event.

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Zealand R&D Day Highlights

Zealand hosted its R&D day (view slides) and provided updates to its diabetes and obesity development programs. Specifically, Zealand highlighted the near-term US approval and launch of the HypoPal glucagon rescue pen, medium-term development of the bi-hormonal iLet pump with Beta Bionics, and long-term research activities in obesity (e.g. amylin analog and GIP agonist). Below, FENIX provides highlights and insights from the events.

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