Xeris pramlintide-insulin candidate shows benefit in mid-stage study

Xeris Pharmaceuticals (NASDAQ:XERS) announces positive results from a Phase 2 clinical trial evaluating candidate XP-3924, a co-formulation of pramlintide and insulin, in adults with type 1 diabetes (T1D).

XP-3924 is designed to reduce post-prandial (after a meal) glucose excursions and variability and improve glycemic control. Pramlintide, marketed as Symlin by AstraZeneca, is a natural hormone that plays a key role in maintaining metabolic homeostasis (balance) thereby preventing post-meal spikes in blood sugar that are common in T1D.

Results from the 18-subject trial showed that the subcutaneous administration of XP-3924 reduced hyperglycemia (blood glucose greater than 180 mg/dL) by 62.3% compared to Eli Lilly’s Humulin R (insulin human injection) 500 U/mL alone. Its effect was comparable to the co-administration of Humulin R and Symlin.

Glucose variability, defined as a comparison of the coefficient of variation of all plasma glucose readings during the six-hour treatment duration, was less with XP-3924 than Humulin alone or in combination with Symlin.

The safety profiles were similar.

The company plans to meet with the FDA later this year to discuss a registration path.

XP-3924’s value proposition is a more patient-friendly approach to blood sugar management by virtue of a single injection instead of two.

https://seekingalpha.com/news/3584129-xeris-pharma-pramlintide-insulin-candidate-shows-benefit-in-mid-stage-study