Knee OA Associated with Bone Marrow Lesions (BMLs)
Knee OA is a disorder characterized by bone changes around the knee joint, progressive loss of joint cartilage, joint space narrowing, and eventual total joint failure. Knee OA results in knee pain, significant physical disability, and reduced quality of life.
Some patients with knee OA exhibit BMLs. BMLs appear as areas of increased signal intensity on MRI of the knee, and are associated with and predict knee pain, disease severity, and structural progression in patients with knee OA, based on published studies. BMLs may therefore be a source of knee pain and a potential target for pharmaceutical intervention.
AXS‑02 (disodium zoledronate tetrahydrate), is a potentially first‑in‑class, oral, targeted, non‑opioid therapeutic for chronic pain. We are initially developing AXS‑02 for the treatment of pain in the following two conditions: knee osteoarthritis (OA) associated with bone marrow lesions (BMLs) and chronic low back pain (CLBP) associated with Modic changes (MCs). AXS-02 has been granted Fast Track designation by the FDA for the treatment of knee OA associated with BMLs. AXS-02 is an investigational product candidate not approved by the FDA.
Knee OA Clinical Trial
AXS-02 is being evaluated in the COAST-1 (Clinical Knee OA Symptom Treatment 1 Study). COAST-1 is a Phase 3, randomized, double blind, placebo-controlled trial to assess the efficacy and safety of AXS-02 in the treatment of the pain of knee OA associated with BMLs. This trial is anticipated to enroll approximately 346 patients with clinically diagnosed knee OA and at least one confirmed BML in the affected knee on MRI. Eligible patients must be at least 50 years of age, either male or postmenopausal female, and have at least moderate pain intensity. After a baseline period, patients meeting the entry criteria will be randomized in a 1:1 ratio to receive either AXS-02 tablets once per week or matching placebo tablets once per week, for 6 weeks. Randomized patients will remain blinded for an additional 18 weeks, totaling 24 weeks for the double-blind phase. The primary endpoint is the change in pain intensity from baseline to week 24. An Independent Data Monitoring Committee (IDMC) conducted an interim analysis of the Phase 3 COAST-1 trial of AXS-02 in knee OA associated with BMLs in January 2018 and recommended that the study continue to full enrollment.
More information about the study can be found at www.clinicaltrials.gov
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