Zealand Pharma and Beta Bionics announce a positive outcome from the Phase 2a clinical safety trial using dasiglucagon in the dualhormone artificial pancreas system, developed at Boston University and licensed to Beta Bionics.
The study was conducted at the Massachusetts General Hospital Diabetes Research Center in Boston, MA, USA. The aim of the trial was to assess the safety, efficacy and tolerability of dasiglucagon when administred automatically using the iLet algorithms. The trial included 10 adult patients with type 1 diabetes, and a marketed recombinant glucagon was used as comparator. The test conditions were chosen to optimize the opportunity to evaluate the ability of dasiglucagon (and comparator) to maintain blood glucose in the desired target glycemic range: subjects arrived fasting at the clinic for the 8 hour testing period, they had their first meal at lunch-time at which time they injected a standard insulin bolus. Their basal rate of insulin was up to twice their normal rate, and following the meal, they were asked to perform 30 minutes of exercise to stimulate the administration of glucagon by the system.
“We now have a stable drug candidate with a potential to be used for automated prevention of hypoglycemia. We’ve shown over the course of several multi-day outpatient and home-use studies that the bihormonal bionic pancreas algorithms regulated sensor glucose to an average of ~140 mg/dl in adults, adolescents, and pre-adolescents with very little input from the user. Until recently, the poor stability of the currently available human glucagon formulations meant that glucagon had to be freshly reconstituted every day in all of our clinical trials. Stable glucagon was the missing piece we needed to make the benefits of this technology available to the large number of people who could benefit from it. Now that we have demonstrated the feasibility of dasiglucagon as a replacement for unstable human glucagon, we can move forward with confidence towards a pivotal registration trial to support approval of the iLet bionic pancreas delivering both insulin and dasiglucagon,” explains Steven J. Russell, MD, Massachusetts General Hospital Diabetes Research Center in Boston, Principal Investigator.
The automated dosing algorithms were observed to deliver both dasiglucagon and recombinant glucagon in response to falling blood glucose. During treatment, even with subjects placed under the challenging conditions of the trial, glucose levels were in the range of 70-180 mg/dl approximately 70% and 65% of the time respectively for dasiglucagon and recombinant glucagon. Dasiglucagon infusion was observed to be safe and well tolerated in the trial, with no injection site reactions noted. No severe hypoglycemic episodes were observed and time below 60 mg/dl glucose was approximately 13% and 18% for dasiglucagon and recombinant glucagon, respectively. A few subjects experienced mild nausea with both dasiglucagon and the recombinant glucagon. This trial, along with the pharmacodynamic data from the recently completed dasiglucagon mircrodose trial, provides the foundation for further clinical development of dasiglucagon in the iLet pump system in out-patient trials.
“We are very pleased with the Phase 2a results, which marks an important step forward in our collaboration with Beta Bionics. The clinical results with dasiglucagon in the iLet dual-hormone artificial pancreas system support that the algorithms used can effectively administer dasiglucagon to prevent and treat falling blood glucose levels. We believe this combined solution of cutting-edge technology and the worlds’s first stable glucagon analog, our dasiglucagon, is a major innovation. This may allow diabetes patients to be less concerned about their disease, eliminating the fear of hypoglycemia while gaining more effective, continuous glucose control. We look forward to initiating the Phase 2b trial with dasiglucagon in the iLet pump system, ” commented Britt Meelby Jensen, President & CEO of Zealand.
The company also recently announced positive clinical trial results from their Phase 2 trial of glepaglutide in adult patients with short bowel syndrome (SBS).