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Xeris Biopharma Announces Plans for a Phase II Dose-Finding Study for Its Investigational Subcutaneous (SC) Levothyroxine (XP-8121) as Replacement Therapy for Hypothyroidism
Targeting initiation of a Phase II study by 2H 2023 CHICAGO--(BUSINESS WIRE)-- Xeris Biopharma Holdings, Inc. (Nasdaq: XERS), a growth-oriented
About this update from Xeris Biopharma Holdings, Inc.
[{"type":"text","content":"\nTargeting initiation of a Phase II study by 2H 2023\n\n CHICAGO--(BUSINESS WIRE)--\nXeris Biopharma Holdings, Inc. (Nasdaq: XERS), a growth-oriented biopharmaceutical company committed to improving patient lives by developing and commercializing innovative products across a range of therapies, today announced that, based on feedback from a Type C meeting with the Food and Drug Administration (FDA), Xeris will proceed with a Phase II study in patients for its novel formulation of levothyroxine sodium (SC injection) as replacement therapy for hypothyroidism. The Company anticipates initiating the study by the second half of 2023.\n\n“We received very productive feedback from the FDA on our proposed clinical plan for our once weekly subcutaneous levothyroxine and are in the process of clarifying some aspects of the Phase II and Phase III recommendations. We believe we have enough clarity to move forward with a Phase II study, which we anticipate having up and running by the second half of 2023,” said Paul R. Edick, Xeris’ Chairman and CEO.\n\n“We are excited to commence our Phase II dose-finding study of XP-8121 in 2023. The study will be designed to assess XP-8121 in patients receiving oral thyroid replacement therapy to establish the average once-weekly dose, accrue chronic safety data, and facilitate a future Phase III program in consultation with the FDA,” said Ken Johnson, PharmD, Xeris’ Senior Vice President, Global Development and Medical Affairs.\n\nIn October, Xeris reported positive topline Phase I data of XP-8121. 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. Importantly, single SC doses of XP-8121 at all doses were safe and well tolerated and no XP-8121 studied dose was different from Synthroid 600 μg PO with respect to the safety findings.\n\nAbout Hypothyroidism\n\nHypothyroidism, or underactive thyroid, happens when your thyroid gland doesn't make enough thyroid hormones to meet your body's needs. Your ...