Post by icemandios on Jun 21, 2023 12:30:36 GMT
Xeris Biopharma Announces First Participant Dosed In A Phase 2 Clinical Study Of Its Investigational Subcutaneous (SC) Levothyroxine (XP-8121) In Patients With Hypothyroidism
Phase 2 study to establish the average once-weekly dose, accrue additional safety data, and facilitate a future Phase 3 program
Xeris Biopharma Holdings, Inc. (Nasdaq: XERS), a growth-oriented biopharmaceutical company committed to improving patients’ lives by developing and commercializing innovative products across a range of therapies, today announced that the first participant has been dosed in a multi-center, open label, Phase 2 study of XP-8121 for the treatment of adults with hypothyroidism.
“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. We believe that our novel SC 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,” said Paul R. Edick, Xeris’ Chairman and CEO.
“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,” said Kenneth E. Johnson, PharmD, Xeris’ Senior Vice President, Global Development and Medical Affairs. “Depending upon enrollment rates, we anticipate completing the study in the first half of 2024.”
The Phase 2 study (NCT05823012) is a non-randomized, open-label, single arm, self-controlled study of XP-8121 (levothyroxine sodium) to determine a target dose conversion factor from stably dosed oral levothyroxine to XP-8121 (levothyroxine sodium) in patients with hypothyroidism and to assess the safety and tolerability of XP-8121 (levothyroxine sodium) after once-weekly subcutaneous injections. This study includes the following periods: Screening, Titration Period (2 to 8 weeks), and Maintenance Period (4 weeks). A pharmacokinetic sub-study will be conducted for a subset of patients during the Maintenance Period.
About Hypothyroidism
Hypothyroidism, or underactive thyroid, happens when your thyroid gland doesn't make enough thyroid hormones to meet your body's needs. Your thyroid is a small, butterfly-shaped gland in the front of your neck. It makes hormones that control the way the body uses energy. These hormones affect nearly every organ in your body and control many of your body's most important functions. For example, they affect your breathing, heart rate, weight, digestion, and moods. Without enough thyroid hormones, many of your body's functions slow down.
About Levothyroxine
Therapeutically, levothyroxine is administered when the body is deficient in the endogenous hormone. Administration of levothyroxine is thus indicated for acquired thyroid disease (primary hypothyroidism), in cases of decreased secretion of TSH from the anterior pituitary gland (secondary hypothyroidism), and in cases of decreased secretion of TRH from the hypothalamus (tertiary hypothyroidism) and for congenital hypothyroidism. In most patients, hypothyroidism is a permanent condition requiring lifelong treatment. The goal of therapy is restoration of the euthyroid state, which can reverse the clinical manifestations of hypothyroidism and significantly improve quality of life.
About Xeris
Xeris (Nasdaq: XERS) is a growth-oriented biopharmaceutical company committed to improving patients’ lives by developing and commercializing differentiated and innovative products across a range of therapies. Xeris has three commercially available products: Gvoke®, a ready-to-use liquid glucagon for the treatment of severe hypoglycemia; Keveyis®, a proven therapy for primary periodic paralysis; and Recorlev® for the treatment of endogenous Cushing’s syndrome. Xeris has a diverse pipeline of development and partnered programs using its formulation sciences, XeriSol™ and XeriJect™, to support long-term product development and commercial success.