Will use Zealand glucagon; N=10, crossover study to assess performance, with <54 mg/dl as secondary outcome; Insulin-only pivotal pushed to 1Q20, bihormonal pivotal now in 1H20
Zealand and Beta Bionics announced that Dr. Steven Russell’s MGH team has initiated the first home-use study of the iLet bionic pancreas with Zealand’s liquid-stable dasiglucagon in a pre-filled cartridge. According to the ClinicalTrials.gov posting, the small feasibility study (n=10 adult type 1s) is designed to assess the safety and reliability of both bihormonal and insulin-only configurations, both with Dexcom G5 CGM; participants are randomized to one configuration for seven days before crossing over to the other for the same duration. Primary outcomes are all related to system performance (e.g., success of drug delivery), and the secondary outcome is time <54 mg/dl. Primary completion is expected in November 2019.
According to an email update from Beta Bionics CEO Dr. Damiano, after completing the $63 million Series B fundraising in January, the public benefit corporation is moving “very fast” toward IDE submissions for two pivotal trials: The insulin-only pivotal trial is now expected in 1Q20 (back from “2H19”), and the bihormonal pivotal is now expected in 1H20 (back from “late 2019/early 2020”). Approval of the bihormonal version is still targeted for 2022.
While this is the first home-use study of the iLet with dasiglucagon, we did see data at ADA 2018 detailing results from a similar home crossover study, but with the Bionic Pancreas algorithm running on a smartphone, one or two Tandem t:slim pumps depending on the arm, and reconstituted Lilly glucagon. Results from this earlier study gave a slight edge to the bihormonal system in terms of glycemic outcomes (time-in-range 79% with bihormonal vs. 72% with insulin-only; both with <1% time <54 mg/dl). We assume the fully integrated iLet device with a pumpable glucagon will deliver better results, given far less hassle and better connectivity.
Testing the iLet device in the bihormonal configuration has been a long time coming – pivotals were initially expected in 2Q17. In that time, however, Beta Bionics has found a commercially viable liquid-soluble glucagon partner, invested heavily in hardware upgrades (Gen 4 iLet), forged ahead with a focus on interoperability/patient choice (multiple insulins; insulin-only vs. bihormonal configurations; two CGM partners in Dexcom and Senseonics), and notched a few high-profile publications.
A home-use trial with the insulin-only Bionic Pancreas (iLet + 90-day Senseonics CGM) finished in November 2018, and results will come at ADA next month (see our preview here). A phase 1 trial for ultra-rapid BioChaperone Lispro in Beta Bionics’ system (iLet + Dexcom CGM) also began in 1H19, with expected primary completion in December (Clinical Trials.gov).
--by Albert Cai, Brian Levine, Adam Brown, and Kelly Close