XT-150 / Xalud Therap - LARVOL DELTA

EFFICACY OF XT-150, A NOVEL NON-VIRAL GENE THERAPY DELIVERING IL-10v, ON MODERATE TO SEVERE PAIN DUE TO KNEE OSTEOARTHRITIS: PATIENT SUBGROUP ANALYSIS (OARSI 2024) - P2 | "XT-150-2-0204 (NCT04124042) evaluated the safety and efficacy of single and repeat intra-articular (IA) doses of XT-150 in patients with moderate-severe knee OA. The purpose of this analysis was to evaluate the efficacy findings based on baseline demographic subgroups."

Clinical • Gene therapy • Gene Therapies • Immunology • Musculoskeletal Pain • Osteoarthritis • Pain • Rheumatology • IL10

Lack of Systemic Effects from Intra-articular XT-150 for the Treatment of Moderate to Severe Pain Due to OA of the Knee: Safety Results from a Phase 2 Trial (ACR Convergence 2023) - P2 | "Background/Purpose: This study (NCT04124042) was designed to assess the safety, tolerability, and efficacy of XT-150, a non-viral gene therapy, in adult participants with moderate to severe pain due to osteoarthritis (OA) of the knee. Safety data from this study support continued investigation of XT-150 for the management of pain and improvement of physical function in patients with knee OA. The local nature of treatment-related AEs and the absence of treatment-related SAEs support a two-dose regimen of 0.45 mg XT-150 (total dose of 0.9 mg) as safe and well-tolerated for future studies. 1."

Clinical • P2 data • Cardiovascular • Gene Therapies • Immunology • Musculoskeletal Pain • Myocardial Infarction • Osteoarthritis • Pain • Rheumatology • IL10

Efficacy of XT-150, a Novel Non-Viral Gene Therapy Delivering IL-10v, on Moderate to Severe Pain Due to Osteoarthritis of the Knee: Results of a Phase 2 Trial (ACR Convergence 2023) - P2 | "Background/Purpose: Interleukin (IL)-10 is a regulator of cytokine activity and has the potential to restore homeostasis in osteoarthritis (OA) of the knee. These data suggest improvement in pain and function with two doses vs one dose of XT-150 and support the future development of repeat doses of XT-150 for the potential treatment of pain from moderate-to-severe knee OA. 1. Kwilasz AJ, et al."

Clinical • Gene therapy • P2 data • Gene Therapies • Immunology • Osteoarthritis • Pain • Rheumatology • IL10

Safety and Efficacy of XT-150 for Facet Joint Osteoarthritis Pain (clinicaltrials.gov) - P2 | N=75 | Completed | Sponsor: Xalud Therapeutics, Inc. | Active, not recruiting ➔ Completed

Trial completion • Back Pain • Immunology • Inflammation • Musculoskeletal Diseases • Musculoskeletal Pain • Orthopedics • Osteoarthritis • Pain • Rheumatology

Functional Improvements In Knee Kinematics During Walking Gait Over Six Months Following Treatment With Xt-150: Pooled Results From Two Clinical Trials (OARSI 2023) - "Purpose: To investigate if an intraarticular injection of a novel non-viral gene therapy delivering a proprietary version of the cytokine IL-10 (XT-150, Xalud Therapeutics, USA), improves knee function in people with symptomatic and radiographic knee osteoarthritis (OA)."

Clinical • Gene Therapies • Immunology • Osteoarthritis • Pain • Rheumatology • IL10

Xalud Therapeutics Presents Clinical Data on XT-150 in Knee Osteoarthritis at the 2023 Osteoarthritis Research Society International World Congress (GlobeNewswire) - P1 | N=24 | NCT03282149 | Sponsor: Xalud Therapeutics, Inc. | "Xalud Therapeutics...announced pooled gait data from a world-renowned gait laboratory in Adelaide, Australia, which served as a study site for two studies of lead candidate XT-150 in patients with knee osteoarthritis (OA)....The results demonstrate a positive signal supporting the use of XT-150 as a potential effective treatment in knee OA with the goal of improving joint function. The data were presented...at the 2023 Osteoarthritis Research Society International (OARSI) World Congress....From baseline to day 180, the knee ROM increased by 4° for the 150 µg group and by 6° for the 450 µg group. Over the same time frame, the placebo group showed no change in knee ROM..."

P1 data • Retrospective data • CNS Disorders • Osteoarthritis • Pain

Safety and Efficacy of XT-150 for Facet Joint Osteoarthritis Pain (clinicaltrials.gov) - P2 | N=75 | Active, not recruiting | Sponsor: Xalud Therapeutics, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Back Pain • Immunology • Inflammation • Musculoskeletal Diseases • Musculoskeletal Pain • Orthopedics • Osteoarthritis • Pain • Rheumatology

Efficacy and Safety of XT-150 in Osteoarthritis of the Knee (clinicaltrials.gov) - P2 | N=289 | Completed | Sponsor: Xalud Therapeutics, Inc. | Active, not recruiting ➔ Completed

Trial completion • Immunology • Osteoarthritis • Pain • Rheumatology

Preliminary Safety and Efficacy of XT-150 in Facet Joint Osteoarthritis (clinicaltrials.gov) - P1/2 | N=0 | Withdrawn | Sponsor: Xalud Therapeutics, Inc. | N=60 ➔ 0 | Trial completion date: May 2023 ➔ Mar 2022 | Initiation date: Jan 2022 ➔ Oct 2021 | Recruiting ➔ Withdrawn | Trial primary completion date: Mar 2023 ➔ Mar 2022

Enrollment change • Trial completion date • Trial initiation date • Trial primary completion date • Trial withdrawal • Immunology • Musculoskeletal Pain • Osteoarthritis • Pain • Rheumatology • Seronegative Spondyloarthropathies

Xalud Therapeutics Doses First Patient in Phase 2a Trial of XT-150 for the Treatment of Facet Joint Osteoarthritis Pain (Businesswire) - "Xalud 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....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)."

Trial status • CNS Disorders • Osteoarthritis • Pain

Safety and Efficacy of XT-150 for Facet Joint Osteoarthritis Pain (clinicaltrials.gov) - P2 | N=60 | Recruiting | Sponsor: Xalud Therapeutics, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Back Pain • Immunology • Inflammation • Musculoskeletal Diseases • Musculoskeletal Pain • Orthopedics • Osteoarthritis • Pain • Rheumatology

Double-blind Safety and Efficacy of XT-150 for Facet Joint Osteoarthritis Pain for the Treatment of Facet Joint Osteoarthritis Pain (clinicaltrials.gov) - P2; N=60; Not yet recruiting; Sponsor: Xalud Therapeutics, Inc.

Clinical • New P2 trial • Back Pain • Immunology • Inflammation • Musculoskeletal Diseases • Musculoskeletal Pain • Orthopedics • Osteoarthritis • Pain • Rheumatology • MRI

Xalud Therapeutics Receives FDA Fast Track Designation for XT-150 for the Treatment of Pain Associated with Osteoarthritis of the Knee (Businesswire) - "Xalud Therapeutics...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."

Fast track designation • CNS Disorders • Osteoarthritis • Pain

Efficacy and Safety of XT-150 in Osteoarthritis of the Knee (clinicaltrials.gov) - P2; N=290; Active, not recruiting; Sponsor: Xalud Therapeutics, Inc.; Trial primary completion date: Nov 2021 ➔ Apr 2022

Clinical • Trial primary completion date • Immunology • Osteoarthritis • Pain • Rheumatology

Preliminary Safety and Efficacy of XT-150 in Facet Joint Osteoarthritis (clinicaltrials.gov) - P1/2; N=60; Recruiting; Sponsor: Xalud Therapeutics, Inc.; Trial completion date: Sep 2022 ➔ May 2023; Initiation date: Sep 2021 ➔ Jan 2022; Trial primary completion date: Aug 2022 ➔ Mar 2023

Clinical • Trial completion date • Trial initiation date • Trial primary completion date • Immunology • Musculoskeletal Pain • Osteoarthritis • Pain • Rheumatology • Seronegative Spondyloarthropathies • MRI

Preliminary Safety and Efficacy of XT-150 in Facet Joint Osteoarthritis (clinicaltrials.gov) - P1/2; N=60; Recruiting; Sponsor: Xalud Therapeutics, Inc.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Immunology • Musculoskeletal Pain • Osteoarthritis • Pain • Rheumatology • Seronegative Spondyloarthropathies • MRI

Xalud Therapeutics Completes Oversubscribed $30 Million Series C Financing (Businesswire) - "Xalud Therapeutics...announced today that it has raised $30 million in a Series C financing...XT-150 is currently being evaluated in a Phase 2b study for moderate-to-severe pain caused by osteoarthritis of the knee, a Phase 1/2a study for peripheral neuropathic pain and a study for facet joint syndrome is expected to be initiated by end of year."

Financing • New P1/2 trial • CNS Disorders • Osteoarthritis • Pain • Peripheral Neuropathic Pain

Efficacy and Safety of XT-150 in Osteoarthritis of the Knee (clinicaltrials.gov) - P2; N=290; Active, not recruiting; Sponsor: Xalud Therapeutics, Inc.; Trial primary completion date: Apr 2022 ➔ Nov 2021

Clinical • Trial primary completion date • Immunology • Osteoarthritis • Pain • Rheumatology

Xalud Therapeutics’ Lead Candidate, XT-150, Achieves Multiple Clinical Milestones in Pathologic Inflammation and Neuroimmunology Therapeutic Areas (Businesswire) - "Xalud Therapeutics...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....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...Topline results are expected in the fourth quarter of 2021...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 trial is currently enrolling."

Enrollment closed • P2b data • Trial status • Neuralgia • Osteoarthritis • Pain

Efficacy and Safety of XT-150 in Osteoarthritis of the Knee (clinicaltrials.gov) - P2; N=290; Active, not recruiting; Sponsor: Xalud Therapeutics, Inc.; Recruiting ➔ Active, not recruiting; Trial primary completion date: Apr 2021 ➔ Apr 2022

Clinical • Enrollment closed • Trial primary completion date • Immunology • Osteoarthritis • Pain • Rheumatology

Efficacy and Safety of XT-150 in Osteoarthritis of the Knee (clinicaltrials.gov) - P2; N=270; Recruiting; Sponsor: Xalud Therapeutics, Inc.; Trial primary completion date: Jul 2021 ➔ Apr 2021

Clinical • Trial primary completion date • Immunology • Osteoarthritis • Pain • Rheumatology

Preliminary Safety and Efficacy of XT-150 in Facet Joint Osteoarthritis (clinicaltrials.gov) - P1/2; N=60; Not yet recruiting; Sponsor: Xalud Therapeutics, Inc.

New P1/2 trial • Immunology • Musculoskeletal Pain • Osteoarthritis • Pain • Rheumatology • Seronegative Spondyloarthropathies

Safety and Efficacy of XT-150 for Treatment of Neuropathic Pain (clinicaltrials.gov) - P1; N=48; Recruiting; Sponsor: Xalud Therapeutics, Inc.; Not yet recruiting ➔ Recruiting; Initiation date: Oct 2020 ➔ Jan 2021; Trial primary completion date: Apr 2021 ➔ Jul 2021

Clinical • Enrollment open • Trial initiation date • Trial primary completion date • Neuralgia • Pain • Peripheral Neuropathic Pain

Efficacy and Safety of XT-150 in Osteoarthritis of the Knee (clinicaltrials.gov) - P2; N=270; Recruiting; Sponsor: Xalud Therapeutics, Inc.; Trial completion date: Sep 2021 ➔ Feb 2022

Clinical • Trial completion date • Immunology • Osteoarthritis • Pain • Rheumatology

Safety and Efficacy of XT-150 for Treatment of Neuropathic Pain (clinicaltrials.gov) - P1; N=48; Not yet recruiting; Sponsor: Xalud Therapeutics, Inc.; Trial primary completion date: Jan 2021 ➔ Apr 2021

Clinical • Trial primary completion date • Neuralgia • Pain