Category Archives: Topics

Novo Initiates Ph3 Sema NASH Trial; BrightInsight Secures $101M in Series C Funding; Amarin Receives EC Approval for Vazkepa CV Risk Reduction; Glytec Updates Glucommander Insulin Dosing Algorithm; Voluntis FY ’20 Earnings Update

A series of cardiometabolic-related news items have been observed: a CT.gov record for Novo Nordisk’s first Ph3 semaglutide NASH trial has been observed; BrightInsight announced it has raised $101M in Series C financing; Amarin announced EC approval of Vazkepa (icosapent ethyl) to reduce the risk of CV events in high-risk, statin-treated adults with elevated triglycerides (≥150 mg/dL) and either established CVD or diabetes and at least one additional CV risk factor; Glytec announced updates to its Glucommander algorithm; and Voluntis announced its FY 2020 results. Below, FENIX provides highlights and insights for the respective news items.

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New Medtronic/InPen MDI Basal+Bolus Advisement Connected System

A trial for a new Medtronic Guardian Connect CGM + connected insulin pen has been observed (view CT.gov record). Interestingly, the CT.gov record states the trial will use the Guardian Connect CGM, smart insulin pens, InPen Diabetes Management app, and a new device referred to as the “InPen Basal smart cap.” Below, FENIX provides an overview of the trial, insight into the potential features of the InPen Basal smart cap, and why this new product may be a reason to adopt a Medtronic solution over a Dexcom solution.

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Novo’s Oral Sema Alzheimer’s Studies Posted on CT.gov; Saxenda Receives Positive CHMP Opinion

Two cardiometabolic-related news items have been observed: the CT.gov records for Novo’s oral semaglutide Ph3 Alzheimer’s disease trials have been posted and Novo Nordisk announced Saxenda received a positive CHMP opinion for the treatment of obesity in adolescents. Below, FENIX provides highlights and insights for the respective 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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Zegalogue (Dasiglucagon) Label Analysis

Zealand recently announced its dasiglucagon hypoglycemia rescue product, branded as “Zegalogue,” received FDA approval (view label; previous FENIX insight). Following the approval, Zealand hosted an investor webcast to provide additional details surrounding the commercialization of Zegalogue (view slides). Below, FENIX has conducted a Zegalogue label analysis in the context of Lilly’s Baqsimi and Xeris’s Gvoke.

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Novo STEP 4 Sema Obesity Results @ ENDO 2021; Oramed Second Oral Insulin Ph3 Trial Update; Dexcom Promotes Jereme Sylvain to CFO; vTv Granted New Patent for TTP399

A series of diabetes-related news items have been observed: Novo Nordisk presented results from the STEP 4 semaglutide 2.4mg obesity trial at the ENDO 2021 conference (view press release); Oramed announced it has screened the first patients in its second oral insulin Ph3 trial; Dexcom has promoted Jereme Sylvain to CFO, allowing Quentin Blackford to take over Steve Pacelli’s responsibilities for strategy and corporate development (view press release); and vTv announced the USPTO issued patent 10,952,993 protecting methods of treatment using TTP399, a novel GKA. Below, FENIX provides highlights and insights from the respective news items, including updated perspective on Oramed’s potential regulatory timeline.

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High-Dose Ozempic Filing Refused by FDA

Novo Nordisk announced it received a Refusal to File letter from FDA regarding the sNDA for high-dose 2.0mg injectable semaglutide. Recall, Novo initially filed the application with FDA on January 20, 2021 (previous FENIX insight). Novo plans to re-file in Q2 ’21. Below, FENIX provides thoughts on the high-dose semaglutide delay in the context of Lilly’s high-dose Trulicity and tirzepatide assets.

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Zealand’s Dasiglucagon Approved; March 22-25 CHMP Agenda; Fractyl Enrolls First Patient in T2DM Study; Twist Bioscience Announces Positive Preclinical Data

A series of cardiometabolic-related news items have been observed: Zealand’s dasiglucagon has been approved in the US as “Zegalogue” for the treatment of severe hypoglycemia in patients 6 years of age and older; the CHMP agenda for this month’s meeting (March 22-25, 2021) has been released; Fractyl announced the first patient has been enrolled in a pivotal trial of Revita DMR; and Twist Bioscience announced positive preclinical data in which its library identified GLP-1R antibodies that demonstrated glucose control. Below, FENIX provides highlights and insights from the respective news items, including thoughts on two potential generic sitagliptin products on the CHMP agenda.

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Omnipod 5 Pivotal Data Meets the Bar and Leaves Room for Further Innovation

Today, Insulet presented Omnipod 5 pivotal data at the 2021 ENDO conference (press release), and the company held an associated call with investors (slides). Omnipod 5 was shown to reach 68-74% TIR with low rates of hypoglycemia (time spent 54 mg/dL of 0.17% in adults and 0.23% in pediatrics). Insulet reiterated that the company anticipates an Omnipod soft launch in Q2 ’21 with a full market release in 2022. Below, FENIX provides an overview of the Omnipod 5 pivotal data, a comparative analysis with Tandem’s Control IQ and Medtronic’s 780G AHCL, and thoughts on how Insulet’s T2DM commentary suggests Lilly may be more inclined to use U200 lispro in Lilly’s own AID system.

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Biocorp Partners to Integrate Mallya into Diabeloop AID System; vTv Initiates New TTP399 Study; Adocia and Sigilon Q4 ’20 Earnings Updates

A series of diabetes-related news items have been observed: Biocorp and Diabeloop announced a partnership to combine Biocorp’s Mallya connected pen device with Diabeloop’s insulin delivery algorithm; vTv Therapeutics announced the initiation of a study exploring the effects of TTP399 on ketone body formation during insulin withdrawal in people with T1DM; and Adocia (press release) and Sigilon (press release) announced their respective Q4 and FY ’20 earnings. Below, FENIX provides highlights and insights for the respective news items.

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