NEW YORK–(BUSINESS WIRE)–Xalud Therapeutics, a clinical-stage biotechnology company developing DNA delivery therapies using a non-viral platform, announced today that the United States Food and Drug Administration (FDA) has granted Fast Track designation to the Company’s lead candidate, XT-150, for the treatment of pain associated with osteoarthritis of the knee. XT-150 is a locally injectable non-viral therapy expressing IL-10v, a proprietary modified variant of IL-10, that addresses pathologic inflammation and pain.
The FDA Fast Track designation allows sponsors to gain access to expedited drug approval reviews for serious medical conditions where there is an unmet medical need. The program is also designed to facilitate drug development by providing for more frequent communications with the FDA to discuss drug development plans and review portions of the Biologic License Application. Fast Track designation can lead to Accelerated Approval and/or Priority Review eligibility if certain criteria are met.
“Receipt of Fast Track designation is supportive of the clinical significance of our lead candidate that leverages plasmid DNA encoding the anti-inflammatory cytokine IL-10v for the treatment of pain associated with osteoarthritis of the knee,” said Diem Nguyen, Ph.D., MBA, chief executive officer of Xalud. “We believe that continued development of our proprietary, non-viral DNA delivery platform will result in multiple drug candidates, with potential to address a large and underserved market for patients that face chronic inflammatory conditions.”
About Xalud Therapeutics
Xalud Therapeutics is a biotechnology company developing a DNA delivery therapy platform to treat pathologic inflammation through immune modulation. The company is harnessing the power of interleukin-10 (IL-10), a potent cytokine that acts as a master regulator for multiple inflammatory pathways, to address the root cause of inflammation and subsequently restore homeostasis in the immune system. Xalud’s lead product candidate, XT-150, is a locally injectable non-viral therapy expressing IL-10v, a proprietary modified variant of IL-10, that addresses pathologic inflammation and pain. For more information, visit www.xaludthera.com.
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