Xeris Biopharma Holdings (NASDAQ:XERS) told investors that the first participant has been dosed in a multi-center, open-label, Phase 2 study of XP-8121 (levothyroxine sodium) for the treatment of adults with hypothyroidism.
The biopharmaceutical company explained that the Phase 2 study (NCT05823012) is a non-randomized, open-label, single-arm, self-controlled study of XP-8121.
The study is aimed at determining a target dose conversion factor from stably dosed oral levothyroxine to XP-8121 in patients with hypothyroidism and to assess the safety and tolerability of XP-8121 after once-weekly subcutaneous injections.
Screening and titration are to take place from two to eight weeks, followed by a four-week maintenance period, during which a pharmacokinetic sub-study will be conducted for a subset of patients, Xeris said.
“Oral levothyroxine is one of the most prescribed medicines in the United States, generating more than 100 million prescriptions per year. However, many patients experience one or more challenges associated with the oral therapy," Xeris chairman and CEO Paul Edick said in a statement.
“We believe that our novel SC (subcutaneous) formulation of levothyroxine has the potential to provide patients with a once-weekly dosing, thereby potentially improving treatment adherence, as well as bypass the gastrointestinal (GI) tract.”
Kenneth Johnson, senior vice president of global development and medical affairs at Xeris, commented; “We are excited to have dosed the first participant in our Phase 2 dose-finding study of XP-8121 and are actively recruiting additional participants that meet the eligibility criteria. We anticipate a lengthy recruitment period as enrolling stably dosed patients with normal TSH on oral levothyroxine is challenging and speaks further to the need of developing a once-weekly SC injection."
Depending upon enrollment rates, Xeris said it anticipates completing the study in the first half of 2024.
Contact the author at stephen.gunnion@proactiveinvestors.com