- Xeris Biopharma Holdings Inc (NASDAQ: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.
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