Xeris Biopharma Announces Positive Topline Phase 1 Clinical Data of Its Investigational Subcutaneous (SC) Levothyroxine (XP-8121); Hosts Conference Call and Webcast
Data demonstrate proof-of-concept showing a once weekly subcutaneous injection of XP-8121 provides similar exposure at steady-state as daily oral Synthroid®
Simulation model implies dose conversion factor of 4X
XP-8121 in healthy volunteers was generally well tolerated at all doses
Data supports further development in patients with congenital or acquired hypothyroidism who require thyroid hormone replacement
FDA End-of-Phase 1 interaction expected by year-end
Company to host conference call and webcast today at
The Phase 1 study was a randomized, open-label, crossover study 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 and to evaluate the relative bioavailability of 600 μg SC XP-8121 versus 600 μg oral (PO) levothyroxine (Synthroid ®). Single dose data from this study were used to develop a population pharmacokinetic model to simulate steady-state exposure (AUC) following weekly SC dosing of XP-8121 or daily PO dosing of Synthroid and to determine the target dose conversion at steady-state from Synthroid PO to XP-8121 SC.
“Oral levothyroxine has been the standard of care treatment for hypothyroidism for many years, and it is one of the most prescribed medicines in
“We are very encouraged with the results of the Phase 1 study of XP-8121, our subcutaneous injection of levothyroxine. 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. Simulations based on the population pharmacokinetic model indicate that exposure from weekly XP-8121 1200 μg SC doses overlaps daily Synthroid PO 300 μg suggesting a dose conversion factor of 4x,” said
Conference Call and Webcast Details
Xeris will host a conference call and webcast today,
After registering, a confirmation email will be sent, including dial-in details and a unique code for entry. The Company recommends registering a minimum of ten minutes prior to the start of the call. Following the conference call, a replay will be available until
Hypothyroidism, or underactive thyroid, happens when your thyroid gland doesn't make enough thyroid hormones to meet your body's needs. Your thyroid is a small, butterfly-shaped gland in the front of your neck. It makes hormones that control the way the body uses energy. These hormones affect nearly every organ in your body and control many of your body's most important functions. For example, they affect your breathing, heart rate, weight, digestion, and moods. Without enough thyroid hormones, many of your body's functions slow down.
Therapeutically, levothyroxine is administered when the body is deficient in the endogenous hormone. Administration of levothyroxine is thus indicated for acquired thyroid disease (primary hypothyroidism), in cases of decreased secretion of TSH from the anterior pituitary gland (secondary hypothyroidism), and in cases of decreased secretion of TRH from the hypothalamus (tertiary hypothyroidism) and for congenital hypothyroidism. In most patients, hypothyroidism is a permanent condition requiring lifelong treatment. The goal of therapy is restoration of the euthyroid state, which can reverse the clinical manifestations of hypothyroidism and significantly improve quality of life.
The proprietary XeriSol™ non-aqueous formulation technology platform is designed to address the limitations of aqueous formulations for peptide and small molecule drugs. The solutions are formulated using biocompatible, non-aqueous solvents that impart high stability and solubility to drugs allowing for development of room temperature stable, ready-to-use formulations. XeriSol™ formulations have been used extensively in global commercial products (Gvoke®/Ogluo®) and clinical trials. The technology is protected by an extensive patent estate, trade secrets and know-how, and it is available for licensing.
Xeris (Nasdaq: XERS) is a growth-oriented biopharmaceutical company committed to improving patient lives by developing and commercializing innovative products across a range of therapies. Xeris has three commercially available products; Gvoke®, a ready-to-use liquid glucagon for the treatment of severe hypoglycemia, Keveyis®, the first and only FDA-approved therapy for primary periodic paralysis, and Recorlev® for the treatment of endogenous Cushing’s syndrome. Xeris also has a pipeline of development programs to extend the current marketed products into important new indications and uses and bring new products forward using its proprietary formulation technology platforms, XeriSol™ and XeriJect™, supporting long-term product development and commercial success.
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