Two new Ph1 trials for Lilly’s tirzepatide have been observed on CT.gov, including a T2DM counter-regulatory response trial to hypoglycemia and another trial evaluating multiple injection sites in subjects with various BMIs. Below, FENIX provides thoughts on the respective trials.
Novo Nordisk hosted its Q2 ’19 earnings call and provided updates to its diabetes business including the recent initiation of the first-in-human study of its novel basal insulin FSI965 as well as Ph2 completion of its anti-IL 21+liraglutide Ph2 trial in new-onset T1DM. Additionally, Novo disclosed that Mylan notified Novo of an ANDA Paragraph IV filing for generic Victoza. Below, FENIX provides highlights and insights from the call including potential readthrough from the recently scheduled Amarin REDUCE-IT adcom (and likely PDUFA delay) to the ongoing oral semaglutide FDA review.
Lilly has initiated SURPASS-5 (add-on to glargine) which is the 5th and final tirzepatide pivotal Ph3 trial for T2DM. Below, FENIX provides an overview of SURPASS-5 as well as insight into why the study is likely using background glargine U100 and not all basal insulins as well as a high-level comparison between SURPASS-5 and the Trulicity AWARD-9 study.
Lilly hosted its Q2 ’19 earnings call and provided updates across its diabetes business. Of note, Lilly’s pipeline now lists empa T1DM as being filed (FDA refused to accept the initial sNDA). Following the 36-week results from Lilly’s AWARD-11 study, Lilly said it plans to file high-dose Trulicity with regulatory authorities “by late 2019.” Furthermore, Lilly’s oral GLP-1RA, called “GLP-1 NPA” (GLP-1 non-peptide agonist), has advanced to Ph1. Below, FENIX provides diabetes-related highlights and insights from the call, including the assumption that the REWIND CHMP agenda listing for July was only for adoption of supplementary information.
Recently, there have been two seemingly interrelated announcements from Hanmi regarding the termination of their GLP-1/GCG dual agonist partnership with Janssen and a restructuring of the deal with Sanofi for efpeglenatide. Below, FENIX provides a summary of these news items and potential read-through.
According to Reuters, Sanofi is set to layoff 466 R&D-related jobs as part of an initiative to prioritize oncology, immunology, rare diseases, and vaccines while at the same time limiting internal CV R&D to its current pipeline. Furthermore, Sanofi is said to maintain the support of its diabetes and CV programs through its partners. Below, FENIX provides thoughts on the Sanofi R&D re-focusing in the context of the company’s CV/Met pipeline and recent senior management changes.
Lilly initiated its Ph3 tirzepatide vs. Ozempic H2H study (SURPASS-2) which is the 4th tirzepatide pivotal trial (not including Japan). The final pivotal trial, SURPASS-5 (add-on to basal insulin), is projected to initiate shortly. Below, FENIX provides an overview of SURPASS-2 as well as insight into the curious observation that the trial does not specify which dose of Ozempic is being used (0.5 or 1.0mg).
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.