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Thursday, May 30, 2024

Xeris Positive Topline Phase 2 Data for Once-Weekly Subcutaneous (SC) Levothyroxine

 XeriSol™ formulation enabled predictable bioavailability and sustained levels of levothyroxine in a once-weekly subcutaneous presentation

Once-weekly SC levothyroxine (XP-8121) participants normalized TSH/T4 levels using 45% less drug than would be needed for their daily oral dose on a weekly basis

Data established an average once-weekly SC dose of XP-8121 and confirmed previous Phase 1 study of a 4X target dose conversion factor when switching from once-daily oral administration of levothyroxine

Participants who completed the study rated higher treatment satisfaction with XP-8121 compared to oral and a majority (72%) indicated a strong preference for the SC route of administration

Study exposed the challenges of achieving and maintaining normal TSH with daily oral levothyroxine therapy

FDA End-of-Phase 2 interaction to facilitate a Phase 3 pivotal study program is expected by year-end

https://finance.yahoo.com/news/xeris-biopharma-announces-positive-topline-113000409.html

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