ARTICLE SUMMARY:
Device companies are not the only ones broadening their diabetes portfolio. Lilly is one of several companies working to develop implantable beta cell therapies, which researchers hope may one day be able to cure type 1 diabetes. Excerpted from our recent feature article.
In August, Eli Lilly, one of the biggest suppliers of insulin and GLP-1 drugs, completed its acquisition of Sigilon Therapeutics, developer of an encapsulated beta cell therapy for T1D. The two have been partners since 2018 and Lilly held an 8.4% stake in the company. Lilly agreed to pay about $36.4 million up front for the company plus up to about $310 million in milestone payments.
The deal was announced one day after FDA issued the first ever US approval for a T1D cell therapy: Lantidra, developed by start-up CellTrans. That product uses allogeneic donor islet cells infused into the hepatic portal vein and requires recipients to take immunosuppressant drugs. In a 30-patient clinical study of Lantidra, 11 of the 30 participants who received the therapy did not need external insulin for one to five years, and 10 remained insulin-free for more than five years. However, some in the study did not achieve any insulin independence, and the majority experienced at least one serious adverse reaction, in some cases requiring discontinuation of immunosuppression and subsequent loss of the cells. CellTrans is developing a future product that uses encapsulated islets, which hopefully will not require immunosuppression.
According to a Lilly spokesperson, the Sigilon product, currently in preclinical development, utilizes induced pluripotent stem cells derived from adult cells, engineered into differentiated insulin-producing pancreatic beta cells, and encapsulated using Sigilon’s Afibromer technology, a biomaterials matrix designed to shield the cells from immune rejection. The goal is to restore insulin production over sustained periods without triggering an immune response, the company says.
Lilly is also investing in connected insulin delivery devices, such as smart insulin-pen systems, and in January 2023 launched its first such offering with a phased US rollout of the Tempo Personalized Diabetes Management Platform. (See “Hello Pharma? Diabetes Is Calling: How Eli Lilly Is Leveraging Digital Diabetes Device Technologies to Help Grow Its Future,” MedTech Strategist, January 30, 2019.)
Tempo consists of Lilly’s pre-filled Tempo insulin pen, the TempoSmart app, and the Tempo Smart Button, a Bluetooth-enabled smart insulin-pen cap that attaches to the top of the Tempo insulin pen. The Button detects and stores insulin dose-related data from the pen and transfers it to the TempoSmart app, which records the data and facilitates data sharing between patients and their physicians. The app was developed in partnership with Welldoc and is a private-label iteration of Welldoc’s BlueStar diabetes management app customized to receive insulin dose data from the Tempo Smart Button. Healthcare providers can access a clinician hub called Tempo Insights to view the data shared by their patients and evaluate insulin dosing patterns.
The Tempo platform also provides users with medication reminders, personalized education resources, and feedback on blood glucose levels. It is integrated with Dexcom CGM systems via a secondary display as well as with the Tempo blood glucose monitor and other compatible BGMs, and it can sync data with wearable devices from Fitbit, Garmin, Google Fit, and the Apple Health app.
Continue reading “As Competitive Landscape Shifts Diabetes Companies Jockey for Position” here.