CHICAGO--(BUSINESS WIRE)--Xeris Pharmaceuticals, Inc. (Nasdaq: XERS), a specialty pharmaceutical company leveraging its novel formulation technology platforms to develop and commercialize ready-to-use injectable and infusible drug formulations, today announced it began dosing patients in a Phase 2 clinical study to evaluate its investigational ready-to-use, fixed-ratio co-formulation of pramlintide and insulin in patients with diabetes.
Currently, pramlintide and insulin must be administered as two injections at separate sites before every meal, complicating the maintenance process for patients. The Company’s XeriSol™ technology allows for simultaneous concentration and stabilization of insulin and pramlintide, which are incompatible in aqueous (water-based) formulations. Xeris is leveraging its unique capability to develop a new fixed-ratio, co-formulation of pramlintide and insulin in a single injection to potentially improve glycemic control after meals in people with diabetes. In addition to the effects of insulin, pramlintide enhances glucose control by slowing the absorption of carbohydrates in the body and serves to complement the body’s interaction with insulin to regulate blood sugar levels.
“The premise of our technology is to simplify and improve therapies that patients rely on every day. With this liquid co-formulation, we have the opportunity to fully unlock the potential of pramlintide in helping persons with diabetes manage their blood sugar levels with a simple combination of commonly used therapies,” said Steven Prestrelski, Chief Scientific Officer of Xeris Pharmaceuticals. “The initiation of this Phase 2 study is our latest step to advance meaningful innovation in the diabetes community and continues the momentum we have built on the heels of our first commercial approval.”
The randomized, open-label, cross-over study will assess the investigational treatment in a group of 18 adults with Type 1 diabetes. The primary objective of the study is to evaluate the pharmacodynamic (PD) and pharmacokinetic (PK) properties of a single injection of pramlintide-insulin compared to single doses of regular insulin and regular insulin plus pramlintide (co-administered as separate injections).
The Company anticipates reporting data from this study in the first half of 2020. For more information on Xeris’ pramlintide-insulin study, visit clinicaltrials.gov, identifier NCT04074317.
About Xeris Pharmaceuticals, Inc.
Xeris (Nasdaq: XERS) is a specialty pharmaceutical company delivering innovative solutions to simplify the experience of administering important therapies that people rely on every day around the world.
With a novel technology platform that enables ready-to-use, room-temperature stable formulations of injectable and infusible therapies, the company is advancing a portfolio of solutions in various therapeutic categories, including its first commercial product, Gvoke™. Its proprietary XeriSol™ and XeriJect™ formulation technologies have the potential to offer distinct advantages over conventional product formulations, including eliminating the need for reconstitution, enabling long-term, room-temperature stability, significantly reducing injection volume, and eliminating the requirement for intravenous (IV) infusion. With Xeris’ technology, new product formulations are designed to be easier to use by patients, caregivers, and health practitioners and help reduce costs for payers and the healthcare system.
Any statements in this press release about future expectations, plans and prospects for Xeris Pharmaceuticals, Inc., including statements regarding the acceptance of Gvoke™ in the marketplace, the market and therapeutic potential of its product candidates, the timing or likelihood of commercialization of its product candidates, the potential utility of its formulation platforms and other statements containing the words "will," "would," "continue," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including, without limitation, 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" section of the most recently filed Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission, as well as discussions of potential risks, uncertainties, and other important factors in Xeris’ subsequent filings with the Securities and Exchange Commission. Any 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.
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