Category Archives: Topics

Bayer Reports Finerenone T2DM DKD Renal Outcomes Trial Topline Results (FIDELIO-DKD) ; EMPEROR-Reduced at ESC 2020

Bayer announced positive topline results from its Ph3 FIDELIO-DKD trial evaluating finerenone in T2DM with CKD. Finerenone demonstrated a delayed progression to the primary composite endpoint (onset of kidney failure, sustained decrease of eGFR ≥ 40% from baseline over at least 4 weeks, or renal death). The specific risk reduction was not disclosed. Below, FENIX provides thoughts on the FIDELIO-DKD results including a curious observation that the press release did not mention anything about safety in the trial.

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Tandem and Medtronic Enter Into “Non-exclusive Patent Cross-license Agreement”

Tandem and Medtronic announced they have entered into a “non-exclusive patent cross-license agreement” for existing and new products and services relating to each companies’ diabetes portfolio; however, there are certain undisclosed exclusions. According to the press release, no payments are being exchanged, and additional terms of the deal are not being disclosed. Below, FENIX provides thoughts on this curious agreement in the context of Tandem’s recent win with UnitedHealthcare (previous FENIX insight).

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First Libre 3 Clinical Study Initiated

A CT.gov record has been observed for what is believed to be the first Abbott Libre 3 clinical trial. Abbott publicly disclosed the existence of Libre 3 during its Q1 ’19 earnings call (previous FENIX insight). Recall, the Libre 2 CGM was recently approved in the US, but its use with integrated systems is limited due to Vitamin C interference (previous FENIX insight). There is no mention of Vitamin C in the Libre 3 CT.gov record. Below, FENIX provides an overview of the new Libre 3 study as well as potential insight into the timing of its initiation in the context of the Libre 2 US label restrictions.

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Tandem Partners with JDRF for Diabetes Device Education Campaign; Livongo’s myStrength App Available for Free to Priority Health Members

Two diabetes-related news items have been observed: Tandem announced it is partnering with JDRF for a national T1DM educational awareness campaign focusing on diabetes technology and Priority Health is providing Livongo’s myStrength mental health app for free to its members. Below, FENIX provides insights into the respective news items, notably the timing of the Tandem/JDRF collaboration given the recent favorable reimbursement decision by UnitedHealthcare (previous FENIX insight).

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Nemaura Files PMA for Non-invasive CGM; Medtronic launches Mio Advance Infusion Set

Two diabetes-related news items have been observed: Nemaura Medical announced it has filed a PMA with FDA for its sugarBEAT non-invasive CGM and Medtronic launched the Mio Advance infusion set in the US. In conjunction with the Nemaura filing announcement, the company also hosted a call with investors discussing the company’s commercial efforts (US and ex-US), partnership opportunities, and development of a new continuous temperature monitor. Below, FENIX provides highlights and insights relating to the sugarBEAT PMA submission as well as brief thoughts on the new Medtronic infusion set.

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New Lilly QW Insulin Ph2 Trials in T1DM and T2DM

Two new Ph2 trials have been observed on CT.gov evaluating Lilly’s QW basal insulin (LY3209590) in T1DM (view CT.gov record) and insulin-naïve T2DM patients (view CT.gov record). Below, FENIX provides trial details and thoughts on the new trials in the context of Novo Nordisk’s QW basal insulin (icodec), which recently had full Ph2 results presented at ADA 2020 (previous FENIX insight).

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Novartis Ph1b PORTIA Results Presented at Virtual AACR II

On Monday, June 23, Novartis presented (Ulrich Jaeger et al, June 2020) updated clinical data from the Kymriah + pembrolizumab (pembro, a PD-1 inhibitor) Ph1 PORTIA study in ≥3L R/R DLBCL. Below, FENIX provides thoughts on the significance of this data, and particularly how it compares to recent CAR-T + checkpoint inhibitor data from Gilead (Yescarta), BMS (Liso-cel), and Autolus (AUTO3).

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Two New Gracell Early Ph1 Trials in MM and NHL Posted

Two new early Ph1 trials from Gracell have been observed on CT.gov: a BCMA/CD19 dual CAR-T in ≥4L R/R MM and another trial evaluating GC022F, a CD22 CAR-T rapidly manufactured <24 hours in ≥2L R/R NHL. Interestingly, both trials are being conducted at the same hospital. Below, FENIX provides insights on these new trials, particularly around how a BCMA/CD19 dual CAR-T could differentiate Gracell within the crowded BCMA MM space.

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CREDENCE Approved by EC

Late yesterday, Janssen’s EU partner, Mundipharma, announced the European Commission approved the Invokana renal protection indication based on results from the CREDENCE renal outcomes study (view the updated summary of product characteristics here). Recall, CREDENCE received a positive CHMP opinion on May 29, 2020 (previous FENIX insight). Below, FENIX provides brief thoughts on the EC approval and expanded market potential.

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Xeris Launches Gvoke HypoPen Autoinjector

Xeris announced the launch of its Gvoke HypoPen autoinjector (pictured below) for the treatment of severe hypoglycemia. The Gvoke website has also been updated, and it now includes a patient DTC video for HypoPen (view here). Below, FENIX provides thoughts on the Gvoke HypoPen launch as well as an analysis of the new DTC campaign in the context of Lilly’s Baqsimi (nasal glucagon) launch.

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