Xeris Biopharma Holdings (NASDAQ:XERS) Inc announced that it will proceed with a Phase II study in patients for its novel formulation of levothyroxine sodium (SC injection) as replacement therapy for hypothyroidism.
The Chicago-based firm made the decision based on feedback from a Type C meeting with the Food and Drug Administration (FDA), Xeris told investors.
“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,” Xeris CEO Paul Edick said in a statement. “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.”
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Phase II 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, according to Ken Johnson, Xeris’ senior vice president, global development and medical affairs.
Earlier this year, Xeris reported positive topline Phase I data of XP-8121 which showed 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.
As well, 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, according to Xeris.
The data highlighted that 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, the company added.
Xeris is a growth-oriented biopharmaceutical company committed to improving patients’ lives by developing and commercializing innovative products across a range of therapies.
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