Xeris Biopharma Concludes Phase 2 Study To Treat Hypothyroidism

The growth-oriented biopharmaceutical company Xeris Biopharma Holdings, Inc., dedicated to enhancing patient lives through the development and commercialization of cutting-edge products across a spectrum of therapies, has released the topline findings from its recently concluded phase 2 multi-center, open-label study of XP-8121 for the treatment of adults with hypothyroidism. With the help of the company's XeriSol formulation technology, XP-8121 makes it possible to administer levothyroxine by SC injection once a week. 

With its unique formulation, levothyroxine becomes much more bioavailable, lowering total drug exposure and facilitating a dosing schedule that may lessen the numerous difficulties in reaching and sustaining a normal level of thyroid stimulating hormone (TSH) when taking daily oral formulations of the drug.

The objective of the phase 2 clinical study (NCT05823012) was to evaluate the safety and tolerability of XP-8121 (levothyroxine sodium) following once-weekly SC injections. It also aimed to identify a target dose conversion factor from stably dosed oral levothyroxine to XP-8121 (levothyroxine sodium) in 46 patients with hypothyroidism. The study was non-randomized, open-label, single arm, and self-controlled.  

“A 2022 study published in the Journal of the Endocrine Society estimated the prevalence of hypothyroidism in the US grew to 11.7% or approximately 30 million adults in 2019*. Innumerable reports have been published documenting the various compliance and absorption challenges that can interfere with the bioavailability of oral levothyroxine. Interestingly, in our own phase 2 study, 40% of patients considered stable at the time of screening were found to have their TSH or T4 outside of normal range. We believe our once-weekly SC injection can enable control in patients who struggle with oral preparations for a variety of reasons,” said Paul R. Edick, Xeris’ chairman and CEO.