NEW YORK--(BUSINESS WIRE)--Xalud Therapeutics, a clinical-stage biotechnology company developing novel non-viral gene therapies to treat pathologic inflammation through immune modulation, today announced that the Phase 2b study of XT-150 in patients with moderate-to-severe pain due to osteoarthritis (OA) of the knee has completed enrollment. Xalud has recently presented promising data from three of its previously completed Phase 1b/2a studies in the same indication in a poster presentation at the Osteoarthritis Research Society International (OARSI) Virtual World Congress held on April 29 – May 1, 2021. XT-150 is a locally injectable, plasmid DNA gene therapy expressing IL-10v, a proprietary modified variant of the cytokine IL-10, to address pathologic inflammation and pain. The company also announced the initiation of their neuropathic pain clinical program with the first patient dosed in the Phase 1/2a study in patients with radicular neuropathic pain due to lumbar disc disease.
“We feel optimistic as we advance toward our key topline clinical readout later this year for our OA program,” said Diem Nguyen, Ph.D., chief executive officer of Xalud. “With the initiation of our neuropathic pain program and plans for our pipeline, we are well positioned to execute on our strategic vision of harnessing the potential of our novel non-viral gene therapy platform to develop safe and effective therapies for a broad array of unresolved chronic diseases driven by inflammation.”
“Treatment of patients with chronic inflammatory conditions remains a large unmet need,” noted Eric J. Grigsby, M.D., president and chief executive officer of Neurovations, the lead principal investigator for the Phase 2 program and the presenter at OARSI. “Through localized delivery of IL-10v, we believe XT-150 may have a large-scale impact in reducing inflammation at several somatic and neurologic targets. It could be a very valuable therapy for treating chronic pain and re-establishing immune system homeostasis for these patients with debilitating pain.”
The focus of the research presented thus far has been to establish the safety profile of XT-150. “The completed Phase 2a studies in 55 patients followed for at least six months show that there have been no drug-related serious adverse events, with only mild to moderate injection site reactions,” noted Howard Rutman, M.D., chief development officer of Xalud. “Importantly, we have seen no evidence of an antibody reaction to IL-10 following XT-150 administration.”
The Phase 2b XT-150-0204 study (NCT04124042), which has now reached its target enrollment of 270 patients with moderate-severe OA of the knee, is a randomized, double-blind, placebo-controlled trial to explore the efficacy, as well as confirm the safety and tolerability, of a single intra-articular injection of XT-150. The primary efficacy evaluation of two potential therapeutic doses of XT-150 (150 and 450 μg) will be assessed at six months, followed by an additional six-month safety follow-up with the opportunity for a second injection. Topline results are expected in the fourth quarter of 2021.
Clinical data from three completed Phase 1b/2a studies of XT-150 were highlighted in a poster presentation at OARSI titled, “XT-150: A Novel Immunomodulatory Gene Therapy for Osteoarthritis Pain in Phase 2B Development.” The analysis shows encouraging safety and potential long duration of efficacy of a single injection of XT-150 in patients with moderate-to-severe OA of the knee. Spanning across more than three years of clinical programs including a currently ongoing trial, no serious adverse events attributed to XT-150 have been reported, and pain relief was observed in patients over the six months of observation.
Neuropathic Pain Program
Xalud also announced that the first patient has been dosed in a Phase 1/2a study of XT-150 in patients with radicular neuropathic pain due to lumbar disc disease (NCT04466410). The randomized, double blind, placebo-controlled Australian study is designed to evaluate the safety, tolerability and efficacy of three dose levels of XT-150 (15, 150 and 450 μg) administered via single intrathecal injection in adults who have been diagnosed with lumbar disc disease with no prior lumbar surgery and with radicular pain symptoms or signs indicating compressive neuropathy. The trial is currently enrolling.
XT-150 is a non-viral gene therapy currently in development for a variety of chronic inflammatory conditions, including ongoing clinical trials for OA and neuropathic pain. XT-150 uses a non-integrating therapeutic plasmid DNA that enables local delivery of IL-10v directly to the site of inflammation. IL-10 is a potent anti-inflammatory cytokine that plays a critical role in maintaining homeostasis and reducing inflammation. Reduced levels of IL-10 expression and signaling have been implicated in a broad array of inflammatory diseases.
About Xalud Therapeutics
Xalud Therapeutics is a biotechnology company developing a non-viral gene 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.