A new Ph3 trial (AWARD-11) evaluating 3.0 and 4.5mg Trulicity has been observed on CT.gov. The trial is projected to complete in Q4 ’19. If no additional trials are required, launch could occur as early as Q1 ‘21 (assuming a full 10-month review).
Boehringer and Lilly announced a collaboration with the University of Oxford to conduct a trial (EMPA-KIDNEY) evaluating the effects of Jardiance on kidney disease progression in patients with established CKD (with and without diabetes).
Lilly and Sigilon Therapeutics announced a collaboration to develop encapsulated beta cell therapies for the potential treatment of T1DM. While other beta cell therapies have remained in early stages of development, Lilly’s financial support and considerable resources greatly increase the likelihood of Sigilon’s therapy advancing.
Two new clinical trials for Lilly’s ultra-rapid-acting insulin lispro (LY900014; also called ultra-rapid lispro or “URLi” pronounced “early” [ur-lee] by Lilly at ATTD 2018), have been observed on CT.gov including a Ph1 H2H PK trial vs. Novo’s Fiasp and a Ph3 study in pumps called PRONTO-Pump.
During Day 2 of JPM, presentations ranged across both diabetes drug (Sanofi, Lilly, Lexicon, and Mylan) and device manufacturers (Dexcom, Insulet, and Roche), although Mylan and Roche did not discuss their diabetes portfolios. Below, find key takeaways from JPM followed by more in-depth coverage.
It was reported on Twitter that at ATTD 2018, Dexcom displayed a slide (pictured below) showing a representation of a smart insulin pen. Additionally, Dexcom presented information on the “fully enhanced Dexcom G6 CGM system” including “Urgent Low Soon Alerts.”
FENIX has conducted a pricing analysis of the SGLT2i and SGLT2i+DPP-IVi FDC classes.
Lilly disclosed major announcements about its diabetes connected care strategy, including intentions to develop an in-house automated insulin-delivery (AID) device as well as a wireless smart pen injection device. As a part of this endeavor, Lilly has engaged in collaborations with Deka R&D Corp., CGM-manufacturer Dexcom, and acquired Montreal-based algorithm startup Class AP. In light of these developments, Lilly has indicated plans to initiate trials by YE 2017 and has suggested it will take 2-3 years for these new devices to reach the market.
An ADA abstract titled “A Novel Formulation of Insulin Lispro Containing Citrate and Treprostinil Shows Faster Absorption and Improved Postprandial Glucose Excursions vs. Humalog in Patients with T1DM” will be presented by Lilly at the General Poster Session on June 10, 2017.
Lilly hosted its Q1 ’17 earnings call and provided an update to its diabetes portfolio including pipeline and LCM activities.