Category Archives: Topics

New Ozempic Switching Study from other GLP-1RA (SUSTAIN SWITCH)

A new CT.gov record for a high-dose semaglutide switching study (SUSTAIN SWITCH) has been observed. In the study, patients will switch from their existing GLP-1RA therapy (not injectable semaglutide) to subcutaneous QW semaglutide (either 0.25 or 0.5mg starting dose) and titrate up to 2.0mg sema. Below, FENIX provides an overview of SUSTAIN SWITCH as well as insight into how Novo Nordisk may leverage the study to pre-emptively position Ozempic vs. Lilly’s tirzepatide.

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Mylan Q4 ’19 Earnings Update; Bs-glargine Briefly Discussed

Mylan hosted its Q4 and FY 2019 earnings call and provided updates to its business. The vast majority of the call revolved around the pending merger with Pfizer’s Upjohn. Of note, Mylan briefly discussed the US regulatory status of its bs-glargine and bs-aspart (in partnership with Biocon). Below, FENIX provides highlights and insights from the call.

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Oramed Oral Insulin Ph2b Cohort B Results

Oramed announced positive topline results from Cohort B of the Ph2b trial evaluating its oral insulin (ORMD-0801) in T2DM patients. Oramed also hosted an associated call with investors to discuss the results. Recall, Oramed announced results from Cohort A of this Ph2b study in November 2019, which demonstrated a statistically significant result for the QD and BID doses but not with the TID dose (previous FENIX insight). Below, FENIX provides highlights of the new data and brief thoughts in the context of the previous Ph2b results, Tresiba’s CVOT (DEVOTE), and Novo’s QW basal insulin (icodec).

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FDA Approves Senseonics Extension Study for 365-Day CGM

Senseonics announced FDA approved an extension phase of the PROMISE clinical trial to allow for a subset of patients to continue the trial for a total of 365 days with a single Eversense implantable CGM sensor. Below, FENIX provides thoughts on how the move from a 90-day sensor to 180- and 365-day sensors may be the catalyst that Senseonics needs to turn around its business.

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Insulet Q4 ’19 Earnings Update

Insulet hosted its Q4 ’19 earnings call (press release) and provided updates to its Omnipod business including the Omnipod Horizon closed-loop system. Of note, Insulet disclosed that it has completed enrollment in the Omnipod Horizon pivotal trial and indicated its intentions to deprioritize concentrated insulin development. Below are highlights and insights from the call.

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New Nemaura H2H CGM Study; Welldoc partners with Redox to integrate BlueStar with EHRs

A series of diabetes-related news has been observed including an announcement that Nemaura plans to initiate a H2H study comparing its sugarBEAT CGM with a “highly successful major incumbent CGM sensor” (press release) as well as Welldoc’s new strategic partnership with Redox Inc., to integrate BlueStar with EHRs (press release). Below, FENIX provides additional highlights and insights on Nemaura’s H2H study, especially in the context of the comparative CGM used in the study.

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MannKind Q4 ’19 Earnings Update

MannKind hosted its Q4 and FY 2019 earnings call and highlighted its new strategy to focus on two therapy areas: endocrinology and orphan lung diseases. Additionally, MannKind laid out its roadmap for an Afrezza pediatric indication. Below, FENIX provides highlights and insights from the call.

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Tandem t:slim Smartphone Control in H2 ’20; Tandem Q4 ’19 Earnings Update

Tandem hosted its Q4 ’19 earnings call and provided updates to its commercial and pipeline activities including the recent launch of Control IQ. Of note, for what is believed to be the first time, Tandem disclosed plans to launch a t:slim X2 remote bolusing feature in H2 ’20. Below, FENIX provides highlights and insights from the call.

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