Xeris Biopharma Posts Encouraging Data From Reformulated Thyroid Hormone Deficiency Treatment In Healthy Participants

Xeris Biopharma Holdings Inc XERS announced topline results from its Phase 1 study of subcutaneous (SC) levothyroxine (XP-8121) in healthy adult volunteers.
Using its XeriSol technology, the company is developing a novel levothyroxine sodium (SC injection) formulation to potentially mitigate certain challenges associated with oral formulations.
The Phase 1 study was conducted in 60 healthy adults.
The study was designed to evaluate the pharmacokinetics, dose proportionality, and safety and tolerability of 600 μg, 1200 μg, and 1500 μg of XP-8121 following SC administration versus oral (PO) levothyroxine (Synthroid ).
Synthroid is used to treat thyroid hormone deficiency.
The data show that subjects receiving XP-8121 SC have slower absorption, lower peak plasma, and higher extended exposure compared to Synthroid PO at the comparable dose of 600 μg.
In addition, exposure was proportional over the range of ascending XP-8121 doses studied.
Single SC doses of XP-8121 at all doses were safe and well tolerated.
Price Action: XERS shares are up 5.28% at $1.30 on the last check Thursday.