Pfizer initiated the first Ph2 study evaluating its oral, small-molecule GLP-1RA (PF-06882961) in 400 T2DM subjects. Recall, during Pfizer’s Q1 ’19 earnings call, senior management said they intended to “swiftly” bring PF-06882961 into Ph2. Below, FENIX provides potential insight into the Ph2 study as well as context from other oral GLP-1RAs in development.
Biocorp announced it received CE Mark for the Mallya, a wraparound pen solution. Mallya turns any disposable or reusable insulin pen into a connected device that collects dosing information and sends it to a companion app. Below, FENIX provides insights and context to the impending Mallya launch including thoughts on how Mallya competes with Companion Medical or could be a compliment to Lifescan’s portfolio.
On the last session of the last day at ADA 2019, there was a dedicated plenary session for the oral semaglutide development program. Despite the timing, the session was very well attended. The session provided an overview of the oral semaglutide molecule, its place in clinical practice (PIONEER 1, 5, and 8), comparison to alternative therapies (PIONEER 2, 3, 4, 7), and CVOT safety and efficacy results (PIONEER 6). Of note, approximately half of the time was dedicated to PIONEER 6. Below, FENIX provides additional thoughts on oral semaglutide including the ongoing regulatory situation, Novo Nordisk’s clear initiation of market-shaping activities, and insight into how oral semaglutide may fuel new patient lead generation of its entire portfolio.
Today, BI/Lilly presented data from the CAROLINA CVOT (Tradjenta vs Glimepiride) at the ADA 2019 conference. The results demonstrated non-inferiority on 3P-MACE for linagliptin vs. glimepiride (11.8% vs. 12.0%; HR 0.98; p<0.0001) in patients with relatively early T2DM and increased CV risk. Of note, the results signaled no difference in CV safety between both groups, thereby disproving the hypothesis of increased CV risk from glimepiride usage. Recall, in February 2019, BI/Lilly announced that CAROLINA met the primary endpoint of non-inferiority on 3P-MACE. Below, FENIX provides additional thoughts on CAROLINA, potential market dynamics, and implications.
14 major news items were observed over the past 2 days including Provention Bio’s teplizumab, dasiglucagon pivotal data, DECLARE and EMPA-REG subanalyses, Afrezza pediatric and fixed titration data, Tandem and Insulet hybrid-closed loop data, and more. Below, FENIX provides context and analysis for the announcements.
Lilly hosted its annual ADA 2019 investors call where senior management primarily discussed the REWIND CVOT readout and tirzepatide T2DM Ph2 results. Additionally, Lilly provided an overview and timeline for its Ph3 tirzepatide obesity program (SURMOUNT) and Ph2 tirzepatide NASH program (SYNERGY-NASH). Below, FENIX provides key commentary and insights from the call.
Novo Nordisk hosted its ADA 2019 investor event immediately following the data readout from Lilly’s REWIND CVOT. Unsurprisingly, Novo compared REWIND to LEADER and SUSTAIN 6. Of note, Novo disclosed plans to initiate its high-dose semaglutide study, SUSTAIN FORTE, in Q2 ‘19. Other topics covered during the call include semaglutide LCM, commentary on Lilly’s tirzepatide, connected pen data, QW basal insulin (LAI287), and more. Below, FENIX provides insights and highlights from the call.
Results from REWIND, which have been 7 months in the making, were presented at the ADA 2019 conference and simultaneously published in The Lancet. In somewhat of a disappointing fashion, REWIND data demonstrated a 12% RRR in 3P-MACE (p=0.026) with nonstatistically significant benefit in both the primary (HR=0.87) and secondary prevention (HR=0.87) cohorts. However, as predicted by the FENIX team (but not Matt), the REWIND results were more in-line with Novo’s LEADER than SUSTAIN 6. Below, FENIX provides thoughts on the REWIND results as well as a favors/disfavors analysis.
Medtronic hosted its annual ADA investor event and provided updates to its diabetes business including a pipeline roadmap over the next 24 months (download slides here). The event appeared to have many of the same themes from the 2018 event with a large focus on competing externally (previous FENIX insight). However, this is believed to be the first time that Medtronic has specifically called out pump and CGM competitors (Tandem and Dexcom), and for the first time, Medtronic management was wearing prototype Synergy CGMs at the event. Below, FENIX provides highlights and insights from the call.
Lilly presented results from its two ultra-rapid-acting lispro (URLi) pivotal trials, PRONTO-T1D and PRONTO-T2D. Below, FENIX provides an overview of the data as well as thoughts on the imbalance in injection site reactions (ISRs) with URLi and the potential market implications.