Xeris Biopharma Holdings Inc (NASDAQ:XERS) has announced positive topline results from its Phase 1 study of subcutaneous (SC) levothyroxine (XP-8121) in healthy adult volunteers.
Using its XeriSol technology, the company is developing a novel formulation of levothyroxine sodium (SC injection) to potentially mitigate many of the challenges associated with oral formulations of levothyroxine.
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"Oral levothyroxine has been the standard of care treatment for hypothyroidism for many years, and it is one of the most prescribed medicines in the United States, generating more than 100 million prescriptions per year,” Xeris chairman and CEO Paul R Edick said in a statement.
“The Phase 1 study results offer initial proof of concept that our novel subcutaneous formulation of levothyroxine has the potential to provide patients with a once-weekly dosing, thereby potentially improving treatment adherence, as well as bypassing the gastrointestinal (GI) tract, thereby mitigating limitations of oral therapy. We have requested a meeting with the FDA and expect feedback by the end of the year," Edick added.
Hypothyroidism, or underactive thyroid, is a condition where the thyroid gland does not make enough thyroid hormones to meet the body's needs. These hormones control many of the body's most important functions and affect breathing, heart rate, weight, digestion, and moods. Without enough thyroid hormones, many of the body's functions slow down, the company explained.
Xeris said the Phase 1 trial was a randomized, open-label, crossover study conducted in 60 healthy adults, 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. The study will also evaluate the relative bioavailability of 600 μg SC XP-8121 versus 600 μg oral (PO) levothyroxine (Synthroid).
"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 Ken Johnson, Xeris senior vice president, global development and medical affairs.
"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," he added.
Xeris is hosting a conference call and webcast today, Thursday, October 20, 2022, at 8.30am Eastern Time. To pre-register for the conference call interested parties can click here
Xeris is a growth-oriented biopharmaceutical company committed to improving patient lives by developing and commercializing innovative products across a range of therapies.
Contact the author at jon.hopkins@proactiveinvestors.com