Date: 2017-12-21
Type of information: Development agreement
Compound: dual hormonal artificial, or bionic, pancreas system - dual-hormone bionic pancreas utilizing both dasiglucagon (liquid formulation glucagon analog) and insulin
Company: Zealand Pharma (Denmark) Beta Bionics (USA - MA)
Therapeutic area: Metabolic diseases
Type agreement: development - collaboration
Action mechanism:
- artificial pancreas/medical device. Beta Bionics'pancreas platform, referred to as the iLet™, is a pocket-sized wearable medical device that autonomously manages blood sugar levels in people with diabetes. The bionic pancreas technology integrated into the iLet was licensed by Beta Bionics from Boston University. This device has demonstrated dramatic improvements in clinical outcomes, including significant reductions in blood glucose levels, reductions in hypoglycemia, and reductions in intersubject and intrasubject glycemic variability in adults, adolescents, and pre-adolescents with type 1 diabetes (New England Journal of Medicine. 2014, 371:313–25; Lancet Diabetes and Endocrinology. 2016, 4:233–43).
Disease: diabetes
Details:
- • On June 10, 2016, Zealand Pharma, a peptide drug discovery, design and development company, and Beta Bionics, a medical technology company, jointly announced that they have engaged in a collaboration. The objective of the collaboration is to combine essential proprietary product rights from each party to advance a new dualhormonal
artificial, or bionic, pancreas system to the next step in its clinical development. Such a system has the ultimate potential to offer people with diabetes on insulin therapy more efficacious, safer, and easier blood sugar control for better long-term disease management and outcomes.
The new system under the collaboration is based on an advanced bionic pancreas platform technology, developed at Boston University and Beta Bionics, which has been integrated into a pocket-sized wearable medical device, called the iLet. Boston University has granted an exclusive worldwide license of the iLet technology to Beta Bionics. The bionic pancreas technology in the iLet is designed for automated delivery of both insulin and glucagon analogs and has been tested and refined in nearly 10 years of clinical trials. All of these trials used recombinant human glucagon, which necessitated daily reconstitution at the point of care.
In future trials, Zealand will evaluate a multiple-dose version of its proprietary novel glucagon analog, ZP4207, with the iLet. ZP4207 is invented and developed by Zealand and has been shown to have a unique stability profile for use in liquid formulation. Zealand Pharma and Beta Bionics expect as a next step in their collaboration to initiate a Phase IIa clinical trial to test safety and efficacy of ZP4207 when used in the iLet. The trial is expected to enroll the first patients with type 1 diabetes in H2 2016.
Financial terms:
Latest news:
- • On December 21, 2017, Zealand Pharma and Beta Bionics announced that they have bolstered their collaboration to advance the development of a dual-hormone bionic pancreas utilizing both dasiglucagon (liquid formulation glucagon analog) and insulin.
- Dasiglucagon, developed by Zealand, has a superior stability profile in liquid formulation and is a potential first-in-class glucagon analog suitable for use in a dual-hormone bionic pancreas system. Ultimately, both companies hope to provide diabetes patients on insulin with a more effective, safer and easier option for management of their disease. Positive Phase 2a results were reported in mid 2017 treating adults with type 1 diabetes with a liquid glucagon in a dual-hormone bionic pancreas with insulin.
- Now Zealand Pharma will invest an initial $ 1.5 million in Beta Bionics. Potential future investments of up to $ 3.5 million are linked to clinical development milestones. The investment is to fund continued development by Beta Bionics on the iLet dual-hormone bionic pancreas towards Phase 2b and Phase 3 development and is made as an equity investment in the Series B offering of Beta Bionics, which has raised an undisclosed sum to date and is ongoing.
- The next step in the clinical development will be to start a Phase 2b study in 2018, testing dasiglucagon in a home-use setting in the iLet.
Is general: Yes
