Novo Nordisk’s Ph3 T2DM high-dose semaglutide trial (SUSTAIN FORTE) has recently been posted on CT.gov. Recall, Novo first disclosed its plans to study high-dose semaglutide in T2DM patients during its Q3 ’18 earnings call. Below, FENIX provides insight into SUSTAIN FORTE including context from Lilly’s recently initiated SURPASS-2 trial (tirzepatide vs. Ozempic) and the ongoing AWARD-11 high-dose Trulicity trial.

Victoza has been approved by FDA for use in pediatric patients down to 10 years of age. Of note, the pediatric indication was approved as a priority review. Results of the ELLIPSE Victoza pediatric study were recently presented at the Pediatric Endocrine Society/PediatricAcademic Societies annual meeting and subsequently published in the NEJM. A Novo press release has not yet been observed. Below, FENIX provides brief thoughts on the approval including the impact to Victoza’s market exclusivity extension.

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.

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.

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.