Xeris Pharmaceuticals Announces FDA Acceptance of its IND Application for XeriSol ™ Levothyroxine (XP-8121) for the Treatment of Hypothyroidism


Currently recruiting healthy participants

CHICAGO, August 11, 2021– (BUSINESS WIRE) – Xeris Pharmaceuticals, Inc. (Nasdaq: XERS), a pharmaceutical company leveraging its new formulation technology platforms to develop and market ready-to-use injectable and infusable drug formulations, has announced today that the Food and Drug Administration (FDA) has cleared the Investigational New Drug Application (IND) for its levothyroxine XeriSol for the treatment of hypothyroidism. The active IND allows Xeris to initiate a phase 1 clinical study for XP-8121 using its new formulation of levothyroxine as an injection under the skin for the treatment of hypothyroidism. The phase 1 study will characterize the pharmacokinetics (PK) and assess the safety and tolerability of XP-8121 in healthy participants.

“Levothyroxine is one of the most prescribed drugs in the United States. However, due to the many challenges associated with oral formulations, there remains one area where unmet needs are significant. We believe that a potentially weekly subcutaneous injection of XeriSol levothyroxine can alleviate many of these challenges and improve compliance. The Phase 1 study is the first step in addressing this unmet need, ”said Kenneth E. Johnson, PharmD, senior vice president of global development and medical affairs, Xeris.

“FDA acceptance of our XP-8121 further underscores the applicability of our XeriSol technology and the progress of our pipeline. We will continue to invest in our pipeline in therapeutic areas where we have an established business footprint, ”said Paul R. Edick, President and CEO of Xeris.

About Levothyroxine and Hypothyroidism

The thyroid gland is responsible for the synthesis, storage and release of metabolic hormones, including thyroxine (T4) and triiodothyronine (T3) [Colucci et al, 2013]. These hormones are crucial in the regulation of critical metabolic processes and are vital for normal growth and development during fetal life, infancy, and childhood.

Therapeutically, levothyroxine is given when the body is deficient in the endogenous hormone. The goal of treatment is the restoration of the euthyroid state which can reverse the clinical manifestations of hypothyroidism and significantly improve the quality of life. [Winther et al, 2016]. The treatment of choice for correcting hypothyroidism is levothyroxine, which is the mainstay of thyroid hormone replacement therapy. It is one of the most prescribed drugs in the United States, but the complexity of maintaining biochemical and clinical euthyroidism in patients receiving oral levothyroxine therapy cannot be underestimated. It has been reported that almost 40% of patients receiving oral levothyroxine treatment are over or undertreated. [Laurent et al, 2018] due to factors which include, but are not limited to, the formulation of the drug, use of the drug with food, drug adherence, use of concomitant medications, and pre-existing medical conditions. Many patients who do not reach target TSH levels are usually managed by simply increasing their daily dose of levothyroxine. [Chiovato et al, 2019]. However, levothyroxine is a drug with a narrow therapeutic index. [Vita et al, 2014], which means that relatively small deviations from the appropriate dose can result in a clinically significant change in pharmacological effects when administered to a patient; thus, titration of oral levothyroxine can be a personalized and incremental process.

About Xeris Pharmaceuticals, Inc.

Xeris (Nasdaq: XERS) is a pharmaceutical company that provides innovative solutions to simplify the experience of delivering important therapies that people rely on every day around the world.

With a new technology platform that enables ready-to-use, room-temperature stable injectable formulations, the company is developing a portfolio of solutions in various therapeutic categories, including its first commercial product, Gvoke® in the United States. XeriJect ™ formulation technologies have the potential to offer distinct advantages over conventional product formulations, including elimination of the need for reconstitution, long-term stability at room temperature, significant reduction in injection volume and eliminating the need for intravenous (IV) infusion. Using technology from Xeris, the new product formulations are designed to be easier to use by patients, caregivers and healthcare practitioners and help reduce costs to payers and the healthcare system.

Xeris is headquartered in Chicago, Illinois. For more information, visit www.xerispharma.com, or follow us on Twitter, LinkedIn or Instagram.

Forward-looking statements

All statements in this press release regarding the future expectations, plans and prospects of Xeris Pharmaceuticals, Inc., including statements regarding the market and therapeutic potential of its products and product candidates, expectations regarding clinical data or the results of planned clinical trials, the timing or likelihood of regulatory approval and commercialization of its product candidates, the timing and likelihood of the acquisition of Strongbridge Biopharma, the timing or likelihood of expansion into additional markets, the timing or likelihood of identifying potential development and commercialization partnerships, the potential usefulness of its formulation platforms and other statements containing the words “will”, “would”, ” will continue ”and similar expressions constitute forward-looking statements within the meaning of Private Security ies Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statement due to various important factors, including, without limitation, the impact of COVID-19 on its business operations, its dependence on third party suppliers for Gvoke® and Ogluo®, the regulatory approval of its product candidates, its ability to market and sell its products, if approved, and other factors discussed in the ” Risk Factors ”of the latest Quarterly Report on Form 10-Q filed with the United States Securities and Exchange Commission (the“ SEC ”), as well as discussions of potential risks, uncertainties and other important factors in subsequent Xeris filings with the SEC. The forward-looking statements contained in this press release speak only as of the date hereof, and Xeris expressly disclaims any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise. .

The Company intends to use the Investor Relations portion of its website as a means to disclose material non-public information and to comply with disclosure obligations under Regulation FD.

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