Category Archives: Other

Novo Partners with Procyon Technologies for T1DM Stem-Cell Treatment; Bigfoot Expands Commercial Leadership Team; JDRF and Provention Bio Launch T1DM Screening Campaign; New Arecor Trial for Ultra-concentrated RAI; City of Hope Initiates Ph1 T1DM Vaccine Trial

A series of diabetes-related news items have been observed: earlier this week, Procyon Technologies LLC announced it has entered into a partnership with Novo Nordisk for the development of an implantable cell encapsulation device to be combined with Novo’s stem cells for the treatment of T1DM; Bigfoot Biomedical announced new hires within the company to build out its commercial team ahead of the Bigfoot Unity US launch; JDRF and Provention Bio announced the launch of T1Detect, a T1DM screening campaign; a clinical trial has been observed for AT278, Arecor’s ultra-concentrated rapid-acting insulin aspart; and City of Hope announced enrollment has opened for a Ph1 T1DM vaccine trial. 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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Thoughts on Ionis Investor Day Event

Yesterday, Ionis hosted its 2020 Investor Day event and provided updates to its pipeline developments, including its PCSK9i that has been licensed to AstraZeneca (ION449/AZD8233). Importantly, Ionis provided details on the discontinuation of its oral formulation of the AZ PCSK9i in favor of a next-gen version. Below, FENIX provides cardiometabolic-related highlights and insights from the event.

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Virta Health Raises $65M in Series D Funding Round

Virta Health announced it raised $65M in a Series D funding round led by Sequoia Capital Global Equities and Caffeinated Capital which values Virta Health at >$1.1B. For context, Virta offers non-pharmaceutical coaching and lifestyle intervention program for chronic metabolic conditions, including T2DM, with the goal of improving patient health and reducing the need for some medications. Below, FENIX provides thoughts on Virta’s funding and valuation in the context of the recent Livongo/Teladoc merger as well as brief thoughts on the Virta value proposition.

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Pharmaceutical Strategies Group Launches “Total Cost of Diabetes Care” Feature for Health Plans and Employers

Pharmaceutical Strategies Group (PSG) announced the launch of a diabetes cost management tool, called “Total Cost of Diabetes Care,” designed for health plans and employers to manage the total cost of diabetes care among their users (view PSG website). Below, FENIX provides highlights from the press release as well as potential readthrough to companies like Livongo, Dario, and Onduo.

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Summary of Novartis Meet the Management Investor Event

Today, Novartis hosted its Meet the Management investor event and provided updates to its commercial and pipeline developments. Below, FENIX provides cardiometabolic-related highlights and insights from the event relating to Entresto, inclisiran (PCSK9i), and pelacarsen (LP(a)).

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Amgen Returns Omecamtiv Rights to Cytokinetics; Risk-reward for CYTK Hinges on FDA Adcom

Amgen (press release) and Cytokinetics (press release) separately announced Amgen provided notice to Cytokinetics of its intention to return development and commercial rights for omecamtiv mecarbil (cardiac myosin activator) and AMG 594 (cardiac troponin activator). Cytokinetics also hosted a call with investors to provide commentary regarding Amgen’s decision and next steps for omecamtiv. Below, FENIX provides thoughts on Amgen’s decision, in the context of other recent partnership dissolution examples, as well as implications from the upcoming Entresto FDA adcom.

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Summary of Tirzepatide SURPASS Ph3 Event

Today, Lilly hosted a webcast presenting an overview of the Ph3 tirzepatide SURPASS program. Of note, Lilly highlighted that topline data from SURPASS-1 is anticipated in mid-December 2020 with US/EU filing in late 2021/early 2022. Below, FENIX provides highlights from the call as well as insights into the incretin dynamics in the T2DM space.

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Imeglimin Ph3 US and EU Development Discontinued by Metavant; Poxel Seeks Other Options

Poxel announced that Metavant, its US and EU development partner for Imeglimin, has decided not to move Imeglimin into Ph3 trials. Recall, in Poxel’s Q3 ’20 earnings update, Poxel disclosed that Metavant was in discussions with FDA regarding the Imeglimin Ph3 program in patients with T2DM and stage 3b or 4 CKD (previous FENIX insight). Below, FENIX provides thoughts on the future of Imeglimin in Western markets.

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FDA Accepts IND for Lilly/Dicerna Cardiometabolic Asset; Gilead/Novo Announce Ph2 PoC NASH Results; Biocorp Launches Mallya in Europe; Nemaura Q3 ’20 Earnings Update; Diabeloop Partners for AID System in Japan

A series of diabetes-related news items have been observed: Dicerna announced FDA accepted Lilly’s IND application for a novel, unknown cardiometabolic asset, LY3561774; Gilead and Novo Nordisk announced positive results from a Ph2 PoC trial evaluating Novo’s semaglutide in combination with Gilead’s investigational FXR agonist and/or its ACC inhibitor for the treatment of NASH; Biocorp announced the launch of its Mallya insulin connected cap in Europe via a partnership with cgmDiabet; Nemaura Medical announced its CY Q3 ’20 (FY Q2 ’21) earnings; and Diabeloop and Terumo Corporation announced a partnership for the joint development of an AID system and exclusive distribution rights in Japan. Below, FENIX provides highlights and insight for the respective news items including curious questions on the Dicerna target split between Lilly-Novo and semaglutide Ph3 combos in NASH.

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