Xeris Pharmaceuticals has reported positive topline results from the trial of novel Xerisol pramlintide-insulin co-formulation XP-3924 in adult patients with type 1 diabetes mellitus.
XP-3924 has been designed to improve the synergistic combination of pramlintide (an amylin-analog) and insulin therapies.
By separately giving these existing therapies in combination reduces both post-prandial glucose excursions and glucose variability and improves overall glycemic control.
The randomised, open-label, active comparator-controlled, three-period cross-over proof-of-concept Phase II study enrolled a total of 18 adult participants with type 1 diabetes.
It was aimed at investigating the pharmacokinetics, pharmacodynamics, and the safety and tolerability of a single dose of XP-3924 compared to co-administration of regular insulin (Humulin R) and pramlintide (Symlin), and to an injection of regular insulin alone (Humulin R).
During the study, patients 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.
Xeris Pharmaceuticals chairman and CEO Paul Edick said: “Results from our proof-of-concept study demonstrate that XP-3924, our XeriSol pramlintide-insulin co-formulation, reduced postprandial glycemic excursions and has the potential to significantly improve the management of glycemic conditions of people with diabetes.
“Pramlintide has many patient benefits yet is underutilised because of its additional daily injection burden. We anticipate an end of Phase II meeting with the FDA later this year to discuss a path forward.”
When the subjects were treated with XP-3924, it resulted in a 62.3% reduction of hyperglycemia after the glucose challenge when compared to Humulin R (p<0.001).
XP-3924 also exhibited comparable postprandial glycemic control to that of the co-administered injections of Humulin R and Symlin.