NEW YORK--(BUSINESS WIRE)--Xalud Therapeutics, a clinical-stage biotechnology company developing DNA-delivered therapeutics, today announced the first patient dosed in a Phase 2a clinical trial of its lead product candidate, XT-150, for the treatment of facet joint osteoarthritis (FJOA) pain. XT-150 is a locally-injectable plasmid DNA gene therapy expressing IL-10v, a proprietary modified variant of human interleukin-10 (IL-10). XT-150 is currently being evaluated in additional clinical trials for the treatment of osteoarthritis of the knee and neuropathic pain.
FJOA, also called spinal arthritis, is driven by inflammation of the spine’s joints, and is a painful, progressive inflammatory condition affecting the vertebral joints in the back and neck. Damage to these joints due to aging or trauma may result in chronic neck or back pain. Lumbosacral FJOA, which occurs in the lower back, is quite common.
“FJOA is a debilitating inflammatory condition that affects millions of individuals in the United States, causing significant quality of life issues,” said Principal Investigator Leonardo Kapural, M.D., Ph.D., a pain physician at the Carolinas Pain Institute and The Center for Clinical Research. “Current treatments only mask symptoms or have short-lived effects, and people living with the condition need access to better treatment options with potential for lasting benefit.”
The Phase 2a trial, being conducted in the United States, is a randomized, double-blind, placebo-controlled trial and is designed to evaluate the safety and efficacy of an intra-articular dose of XT-150 for FJOA. The trial will enroll up to 60 participants in one of two XT-150 dose groups or placebo (20 participants per group).
“We believe that restoring immune system homeostasis at the site of inflammation for those suffering from FJOA will provide meaningful long-term pain relief and possibly reduce the need for more invasive treatments,” said Diem Nguyen, Ph.D., MBA, chief executive officer of Xalud. “Our belief is that XT-150 has the potential to be a safe and scalable solution that may alleviate the high disease burden associated with FJOA and other chronic inflammatory conditions.”
About Xalud Therapeutics
Xalud Therapeutics is a biotechnology company developing a DNA-delivered therapy platform to treat pathologic inflammation through immune modulation. Xalud 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 plasmid DNA gene therapy expressing IL-10v, a proprietary modified variant of IL-10, that addresses pathologic inflammation and pain. For more information, visit www.xaludthera.com.