The Food and Drug Administration (FDA) has granted Fast Track designation to XT-150 for the treatment of pain associated with osteoarthritis of the knee.

XT-150 is a locally injectable non-viral therapy expressing interleukin (IL)-10v, a proprietary modified variant of IL-10. The investigational treatment uses a non-integrating therapeutic plasmid DNA that allows local delivery of IL-10v directly to the site of inflammation. 

The designation is supported by clinical data from phase 1b/2a studies, which showed promising safety and potential long duration of efficacy from a single injection of XT-150. The Company is currently evaluating the efficacy and safety of a single intra-articular injection of XT-150 in adults with moderate to severe pain due to osteoarthritis of the knee in a phase 2b study (ClinicalTrials.gov Identifier: NCT04124042).

The FDA’s Fast Track process allows for expedited review of drugs that are expected to fill an unmet need such as providing a therapy that may be better than currently available treatments.

“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.”

References

  1. Xalud Therapeutics receives FDA Fast Track designation for XT-150 for the treatment of pain associated with osteoarthritis of the knee. News release. Xalud Therapeutics. Accessed December 17, 2021. https://www.businesswire.com/news/home/20211217005057/en/
  2. Xalud Therapeutics’ lead candidate, XT-150, achieves multiple clinical milestones in pathologic inflammation and neuroimmunology therapeutic areas. News release. Xalud Therapeutics. May 20, 2021. Accessed December 17, 2021. https://www.businesswire.com/news/home/20210520005172/en/Xalud-Therapeutics%E2%80%99-Lead-Candidate-XT-150-Achieves-Multiple-Clinical-Milestones-in-Pathologic-Inflammation-and-Neuroimmunology-Therapeutic-Areas.