Zealand Pharma A/S (CPH:ZEAL), a biotechnology company focused on the discovery and development of peptide-based medicines, and Beta Bionics Inc announced on Thursday that a phase 2 home-use study of dasiglucagon in the iLet Bionic Pancreas System has been successfully completed.

The iLet, developed by Beta Bionics, is the world's first autonomous bionic pancreas device. It is a bihormonal system leveraging lifelong machine learning and artificial intelligence to deliver insulin and glucagon analogs for the autonomous treatment of type 1 diabetes (T1D).

In addition to dosing insulin, the iLet doses dasiglucagon, a glucagon analog with a unique stability profile in a ready-to-use aqueous solution. Dasiglucagon is in development by Zealand Pharma.

This home-use clinical trial was conducted at the Massachusetts General Hospital (MGH) and was designed as a randomised, two-period, cross-over trial to assess whether the iLet operated as intended.

The trial compared operational performance of the iLet in the insulin-only configuration for one week versus the bihormonal configuration for one week in 10 adult participants with T1D. Trial participants started therapy by entering only their body weight into the device. There was no device training period and no physician intervention to optimise therapy. The iLet is designed to autonomously and continuously adapt to each patient's changing insulin needs. This adaptation is typically most pronounced in the first 24 hours after the initiation of therapy.

The iLet operated as expected, meeting the primary aim of the study. Preliminary data analysis demonstrated that the bihormonal iLet using dasiglucagon provided superior glycaemic control over the insulin-only iLet.

Beta Bionics and Zealand Pharma have partnered to carry out several co-development activities with the primary goal of obtaining regulatory approval to use dasiglucagon in the bihormonal configuration of the iLet.

Also, the two companies are planning for a phase 3 pivotal trial testing the bihormonal configuration of the iLet with dasiglucagon in 2020. This proposed trial is intended to support regulatory submission to the US FDA of a pre-market approval (PMA) application and a new drug application (NDA) for the bihormonal configuration of the iLet with dasiglucagon in people with T1D.

Beta Bionics is a for-profit Massachusetts public benefit corporation founded in 2015 to commercialise the iLet, a bionic pancreas system that is driven by mathematical dosing algorithms to autonomously control glycaemia.