Zealand Pharma reports via Globe News Wire that it dosed its first patient in its Phase 3 trial with dasiglucagon for the treatment of congenital hyperinsulinism (CHI). CHI is a rare pediatric disease with high unmet medical need according to the industry sponsor. The sponsor believes its investigational treatment, dasiglucagon, has the potential to transform the lives of children with CHI and possibly save them from undergoing major surgery with severe lifelong implications. Zealand Pharma A/A (NASDAQ: ZEAL) is a Denmark-based biotechnology company focusing on the discovery and development of innovative peptide-based medicines.
Dasiglucagon is a Zealand-invented glucagon analog with a unique stability profile in a ready-to-use aqueous solution. The molecule has been designed to be stable in solutions and thus suitable for chronic pump use. In 2017, both the U.S. FDA and the European Commission granted orphan drug designation for dasiglucagon for the treatment of CHI. Zealand is also pursuing several indications where dasiglucagon’s stable profile could provide new treatment options: dasiglucagon HypoPal® rescue pen for severe hypoglycemia and dasiglucagon dual-hormone pump therapy for diabetes management.
CHI is a rare disease affecting mainly newborns and toddlers reports the sponsor. It is caused by a defect in pancreaticcells, resulting in insulin overproduction. This leads to persistently and often severely low blood sugar levels (hypglycmeia). CHI developed in one out of 50,000 (or fewer) children. This equals about 180-300 children diagnosed I the U.S. and Europe every year.
Founded in 1998, they are a biotech company with leading-edge scientific expertise in turning peptides into medicines. Zealand has a growing proprietary pipeline of novel specialty drug candidates and a mature portfolio of products and projects under license collaborations with Sanofi, Helsinn Healthcare and Boehringer Ingelheim. Zealand’s first invented medicine, lixisenatide, a once-daily prandial GLP-1 analogue for the treatment of Type 2 diabetes, is marketed globally outside the US as Lyxumia:registered: by Sanofi and under regulatory review in the US. The license collaboration with Sanofi covers also a single-product combination of lixisenatide and insulin glargine (Lantus:registered:) which is on track for regulatory submission in the US in December 2015 and in the European Union in Q1 2016. The proprietary pipeline includes: danegaptide for ischemic reperfusion Injuries in Phase II development; ZP1848 for Short Bowel Syndrome in Phase II development; and the stable glucagon analogue, ZP4207, in Phase II preparation both as a single-dose rescue pen for severe hypoglycemia and for multiple-dose use to treat and control mild to moderate hypoglycemia; as well as several preclinical peptide therapeutics. The company is based in Copenhagen (Glostrup), Denmark.
The lead investigator for the CHI trial is Dr. Indi Banerjee, head of the North England CHI NHS service. He is stated, “I am excited to witness the initiation of the first phase 3 drug development program specific to this complex rare disease. If successful, it could have significant impact on the brain development of the affected children, and allow their families to regain control of their lives.” The sponsor is planning a second Phase 3 trial in 2019. This trial will similarly evaluate safety and efficacy of administering dasiglucagon via a pump. All children that would derive benefit from the investigational treatment by the end of the trials will be offered continuation of treatment in a long-term, open-label extension trial.
Dr. Indi Banerjee, head of the North England CHI NHS service