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Xalud Therapeutics Receives FDA Fast Track Designation for XT-150 for Treatment of Pain Associated with Osteoarthritis of the Knee | Nation / World

NEW YORK – (BUSINESS WIRE) – Dec. 17 2021–

Xalud Therapeutics, a clinical-stage biotechnology company developing DNA delivery therapies using a non-viral platform, today announced that the U.S. Food and Drug Administration (FDA) United 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 topically injectable non-viral therapy expressing IL-10v, a proprietary modified variant of IL-10, which treats pathologic inflammation and pain.

The FDA Fast Track designation allows sponsors to access 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 allowing more frequent communications with the FDA to discuss drug development plans and review portions of the biologic license application. The Fast Track designation may lead to eligibility for expedited approval and / or priority review if certain criteria are met.

“Obtaining the Fast Track designation confirms the clinical importance of our lead candidate which exploits the 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, Managing Director of Xalud. “We believe that the continued development of our proprietary non-viral DNA delivery platform will result in multiple drug candidates, with the potential to address a large and underserved market for patients facing challenges. chronic inflammatory diseases. “

About Xalud Therapeutics

Xalud Therapeutics is a biotechnology company developing a DNA delivery therapy platform to treat pathological inflammation through immune modulation. The company harnesses the power of interleukin-10 (IL-10), a potent cytokine that acts as a primary regulator of several inflammatory pathways, to attack the root cause of inflammation and subsequently restore homeostasis of the immune system. Xalud’s lead product candidate, XT-150, is a topically injectable non-viral therapy expressing IL-10v, a proprietary modified variant of IL-10, which treats pathologic inflammation and pain. For more information visit www.xaludthera.com.

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KEYWORD: UNITED STATES NORTH AMERICA NEW YORK

INDUSTRY KEYWORD: FDA BIOTECHNOLOGY GENETIC HEALTH PHARMACEUTICAL

SOURCE: Xalud Therapeutics

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PUB: 12/17/2021 8:00 a.m. / DISC: 12/17/2021 8:01 a.m.

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