XERS - Xeris injectable therapy for hypothyroidism matches oral formulation in phase 1 trial

Xeris Biopharma Holdings ( NASDAQ: XERS ) said its once weekly subcutaneous (SC) injection of levothyroxine (XP-8121) showed similar exposure at steady-state as daily oral levothyroxine (Synthroid) in a phase 1 trial in healthy people.

The data supports further development of the treatment for patients with congenital or acquired hypothyroidism who require thyroid hormone replacement, the company said on Thursday in a press release.

Using its XeriSol technology, Xeris is developing a novel formulation of levothyroxine sodium (SC injection) to potentially mitigate challenges linked with oral formulations of levothyroxine.

The phase 1 trial included 60 healthy adults and evaluated the pharmacokinetics, dose proportionality, safety and tolerability of 600 ?g, 1200 ?g, and 1500 ?g of XP-8121 after SC administration. The study also tested the relative bioavailability of 600 ?g SC XP-8121 versus 600 ?g oral (PO) levothyroxine (Synthroid).

"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 ?g. In addition, exposure was proportional over the range of ascending XP-8121 doses studied," said Ken Johnson, Xeris' senior vice president, Global Development and Medical Affairs.

Johnson added that single SC doses of XP-8121 at all doses were safe and well tolerated.

Hypothyroidism is a condition wherein the thyroid gland does not produce certain hormones enough.

XERS +4.07% to $1.28 premarket Oct. 20

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