medmix AG Partners with Xeris Pharmaceuticals for Precise Drug Delivery
News related to:medmix AG · 2 min read
medmix AG, a global leader in high-precision delivery devices, has announced a collaboration with Xeris Pharmaceuticals to support the development of XP-8121, an investigational once-weekly subcutaneous levothyroxine therapy for the treatment of hypothyroidism. XP-8121 combines a proprietary high-concentration XeriSol® levothyroxine formulation with an adjustable D-Flex™ pen injector, designed to deliver precise fixed doses based on patient needs.
The D-Flex™ platform, which has been marketed since 2023, is a key component of the partnership. It leverages a unique dosing technology to achieve dose accuracy significantly exceeding ISO 11608-1 requirements. This is particularly crucial given that levothyroxine, classified by the U.S. Food and Drug Administration as a drug with a narrow therapeutic index (NTI), demands precise dose delivery to avoid over- or undertreatment and associated adverse effects.
"Patients living with hypothyroidism deserve a treatment option that is both effective and precise in its delivery," said Pete Valentinsson, Senior Vice President, Global Technical Operations at Xeris. "Following a rigorous evaluation of available device solutions, D-Flex™ distinguished itself by consistently demonstrating the dose accuracy that our investigational XP-8121 demands. Its selection as our preferred device platform reflects our unwavering commitment to developing treatments that meet the highest standards of safety, reliability, and patient-centered care."
Dr. Oliver Haferbeck, Head of Business Unit Drug Delivery at medmix, echoed Valentinsson's sentiments, adding, "Precise dose delivery is an important requirement for many next-generation therapies, particularly in the field of NTI drugs. We are proud to support Xeris and their development of XP-8121 with a device platform that has demonstrated outstanding dose accuracy and helps make these therapies available to patients."
The D-Flex™ platform's capabilities extend beyond dose accuracy. It incorporates a patented dosing mechanism that allows patients to select only intended dose settings, reducing the potential for dosing errors. The platform supports multiple fixed-dose configurations within a single device design and enables the administration of very small dose increments of down to 0.005 mL. Additionally, it can be adapted for dose volumes of up to 0.75 mL, depending on the intended treatment application.
"Beyond the technical achievement, the successful design verification testing of D-Flex™ against ISO 11608-1 provides additional confidence for pharmaceutical companies developing therapies for which dosing precision is particularly important," said Valentinsson.
The collaboration between medmix AG and Xeris Pharmaceuticals underscores the growing demand for delivery devices capable of supporting increasingly complex therapies while meeting strict performance requirements. It further highlights the value of close collaboration between pharmaceutical and device companies in translating new therapeutic concepts into practical treatment options for patients.
As a global leader in high-precision delivery devices, medmix AG has established an extensive manufacturing and supply infrastructure. The D-Flex™ platform, which has been deployed in an approved European product variant and an ongoing U.S. clinical program, has already demonstrated limited device-related novelty and reduced development risk.
In conclusion, the partnership between medmix AG and Xeris Pharmaceuticals represents a significant step forward in the development of precise and reliable delivery solutions for complex therapies, particularly those with a narrow therapeutic index.