Beta Bionics and Zealand Pharma announce superior glycemic control in Phase 2 home-use clinical trial testing the iLet™ bionic pancreas using dasiglucagion
First home-use trial of the iLet Bionic Pancreas System using pre-filled cartridges of dasiglucagon compatible with iLet has been successfully completed
The preliminary study results reveal superior blood glucose control during the study period that used the bihormonal configuration of the iLet with dasiglucagon compared to the period that used the insulin-only configuration
iLet therapy was initialized with body weight only, with no device training periods, and with no physician intervention to optimize therapy
Boston, MA and Copenhagen, Denmark – June 6, 2019 – Beta Bionics, Inc. and Zealand Pharma A/S (NASDAQ: ZEAL, company announcement No. 19/2019) announced today that a 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 — 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 by Dr. Steven Russell and his clinical research team at the Massachusetts General Hospital (MGH) and was designed as a randomized, 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 optimize 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 glycemic control over the insulin-only iLet. During the bihormonal period, participants achieved a mean glucose level, as measured by continuous glucose monitoring (CGM), of 139 mg/dL on days 2–7 of use, versus 149 mg/dL during the insulin-only period (p <0.01). During the bihormonal period, participants spent 79% of the time with their CGM glucose level in range (70–180 mg/dL) on days 2–7 of use, versus 71% during the insulin-only period (p<0.01). During the bihormonal period, 90% of participants had a mean CGM glucose level of < 154 mg/dL, a level that corresponds to an HbA1c level of 7%, the therapeutic goal for adults recommended by the American Diabetes Association. In contrast, 50% of participants had a mean CGM glucose level < 154 mg/dL during the insulin-only period.
Hypoglycemia was observed to be low throughout the study. The mean percentage of time CGM glucose was < 54 mg/dL was 0.3% during the bihormonal period versus 0.6% during the insulin-only period. The mean percentage of time CGM glucose was < 70 mg/dL was 2.4% during the bihormonal period versus 3.6% during the insulin-only period.
“We are extremely pleased to have now tested the performance of our bihormonal iLet Bionic Pancreas System with dasiglucagaon — the first-ever, liquid-stable glucagon analog — in a convenient ready-to-use, pre-filled cartridge designed to fit our system,” said Ed Damiano, Co-founder and President & CEO of Beta Bionics. “Preliminary results from this trial have helped reaffirm the final implementation of our dosing algorithms in the bihormonal configuration of the iLet. I am ecstatic about this historic achievement for Beta Bionics, Zealand Pharma, and our clinical collaborators at MGH, and I am looking forward with eager anticipation to the day when people with T1D can enjoy the real-life benefits of combining ready-to-use dasiglucagon with the 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.
“The bihormonal iLet Bionic Pancreas System demonstrated tight glycemic control in a home-use setting with dasiglucagon,” commented Emmanuel Dulac, President and Chief Executive Officer at Zealand Pharma. “We look forward to proceeding with the Phase 3 trial and continuing to demonstrate the transformational opportunity that the iLet with dasiglucagon could offer for improved and fully automated diabetes management.”
Beta Bionics and Zealand Pharma are planning for a Phase 3 pivotal trial testing the bihormonal configuration of the iLet with dasiglucagon in 2020. That trial is intended to support regulatory submission to the U.S. 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.