A New Therapeutic Approach

How It Works
The active molecule in AXS‑02 is a potent inhibitor of the bone‑resorbing cells called osteoclasts. Osteoclasts break down bone by secreting protons or acid. As acid is known to excite pain receptors, the effects of AXS-02 on osteoclasts may reduce pain by suppressing localized over-production of acid in bone. AXS-02 may also inhibit the production of pro‑inflammatory cytokines which have been shown to contribute to pain.

Clinical
AXS-02 is also in a Phase 3 trial in knee OA associated with BMLs. This trial has received a Special Protocol Assessment (SPA) from the FDA. AXS-02 has been granted Fast Track by the FDA for the treatment of knee OA associated with BMLs.

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.

An additional Phase 3 trial with AXS-02 is planned in CLBP associated with MCs.

Product Pipeline

Indications

Knee Osteoarthritis (OA)
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 bone marrow lesions (BMLs). BMLs appear as areas of increased signal intensity on MRI of the knee, and are associated with knee pain, disease severity and disease progression. Results of epidemiological studies suggest that there are approximately 12 million patients in the United States, 50 years of age and older, with symptomatic knee OA, of whom an estimated approximately 7 million have BMLs.

More about knee OA

Chronic Low Back Pain (CLBP) Associated with Modic Changes (MCs)
CLBP is defined as persistent or fluctuating low back pain lasting at least three months. MCs are vertebral bone marrow changes that are visible on MRI of the spine, and that represent regions of increased bone turnover and pro‑inflammatory mediators. Results of epidemiological studies suggest that there are approximately 121 million adults in the United States with low back pain in a given year. Approximately 9 million of these sufferers are estimated to have CLBP, of whom we estimate approximately 1.6 million have type 1 MCs.

More about CLBP