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Xeris Pharmaceuticals Announces Positive Topline Results from the Phase 2 Comparative Study of a Novel Pramlintide-insulin Co-formulation (XP-3924) in Adults with Type 1 Diabetes Mellitus
XP-3924 resulted in a 62% reduction of hyperglycemia after a glucose challenge XP-3924 showed improved glucose control when compared to Humulin® R alone
About this update from Xeris Biopharma Holdings, Inc.
[{"type":"text","content":"\nXP-3924 resulted in a 62% reduction of hyperglycemia after a glucose challenge\n\n\nXP-3924 showed improved glucose control when compared to Humulin® R alone\n\n\nXP-3924 showed promising glucose control when compared to both Humulin® R and co-administered injections of Humulin® R and Symlin®\n\n\nXP-3924 was observed to be safe and well tolerated in this study\n\n CHICAGO--(BUSINESS WIRE)--\nXeris Pharmaceuticals, Inc. (Nasdaq: XERS), a specialty pharmaceutical company leveraging its novel technology platforms to develop and commercialize ready-to-use injectable and infusible drug formulations, today announced positive topline results from a proof-of-concept Phase 2 study of a novel Xerisol™ pramlintide-insulin co-formulation (XP-3924) in adults with type 1 diabetes mellitus. \n\n\nXP-3924 is designed to improve the synergistic combination of two complementary therapies: pramlintide (an amylin-analog) and insulin. The separate administration of these existing therapies in combination reduces both post-prandial glucose excursions and glucose variability, as well as improves overall glycemic control. A pramlintide-insulin co-formulation may help reduce the daily burden associated with pramlintide co-administration (e.g., reduce the multiple additional injections needed per day). This reduction in the multiple injection burden using XP-3924 may also improve longer term pramlintide treatment adherence and persistency.\n\n\nThe completed Phase 2 study was a randomized, open-label, active comparator-controlled, three-period cross-over study, which enrolled 18 adult participants with type 1 diabetes. This study aimed to investigate the pharmacokinetics, pharmacodynamics, and the safety and tolerability of a single dose of XP-3924 (administered based upon the subjects’ insulin:carbohydrate ratio), when compared to co-administration of regular insulin (Humulin® R) and pramlintide (Symlin®), and to an injection of regular insulin alone (Humulin® R). Subjects were randomly allocated to a sequence of three treatments: XP-3924 (with 50% insulin reduction), regular insulin, or regular insulin (with 50% insulin reduction) plus pramlintide co-administered as separate injections. The study drugs were administered subcutaneously (SC) before the intake of a standardized 75-gram oral glucose challenge. The subjects’ blood glucose levels were mon...