Zealand taps Beta Bionics to hustle artificial pancreas into the clinic

Zealand Pharma (CPH:ZEAL) has teamed up with Beta Bionics to develop an artificial pancreas. The collaboration, which is aiming to enter the clinic this year, is pairing Zealand’s stable liquid glucagon analog ZP4207 with Beta Bionics’ automated, continual diabetes monitoring and drug delivery system.

Copenhagen, Denmark-based Zealand’s contribution to the alliance is ZP4207, part of the drug component of the planned drug-device combination product. Zealand developed ZP4207 as a single-dose rescue treatment for severe, acute hypoglycemia, an indication in which it is already being trialled. Notably, as a stable liquid glucagon analog the drug could solve one of the problems faced to date by Beta Bionics’ iLet device, raising the possibility that the partners can develop a dual-hormone system that mimics the activity of a healthy pancreas.

Beta Bionics and Zealand's contributions to the combination are experimental. Zealand expects to have data from a Phase II, single-dose trial of ZP4207 in the second half of this year, the same window it is targeting for enrollment of the first patients in a study of the artificial pancreas. Beta Bionics has tested the technology behind iLet in outpatient and home-use trials, leading to publications in the New England Journal of Medicine and Lancet Diabetes and Endocrinology, as well as a $5 million (€4.4 million) investment from Eli Lilly ($LLY). Lilly provides the insulin used in the device.

ZP4207 is expected to address a limitation identified in those early clinical trial programs, namely the short shelf life of glucagon formations. The protocol of the study written up in NEJM called for the daily replacement of the glucagon in the pump with freshly-reconstituted material, a stipulation that limited the potential to turn the technology into a scalable commercial dual-hormone system. This has been a long-standing problem. “We have long awaited and eagerly anticipated the development of a stable pumpable glucagon analog,” Beta Bionics CEO Ed Damiano said in a statement.

Having gained access to a glucagon analog that could meet its requirements, Boston, MA-based Beta Bionics is now working with Zealand to get into the clinic later this year. If the product lives up to the partners’ expectations, it will enable type I diabetics to control their condition using a pocket-sized wearable device that continually monitors blood glucose levels, calculates insulin and glucagon doses and delivers the drugs.

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