Axsome Announces CREATE-1 Interim Analysis Expected Year-End 2017
The IDMC will also perform the planned interim analysis of the Phase 3 COAST-1 trial of AXS-02 in knee osteoarthritis (OA) associated with bone marrow lesions (BMLs). Because of member availability, and for efficiency, the IDMC will analyze both CREATE-1 and COAST-1 trials at the same committee meeting. Therefore interim analysis results for COAST-1 are now also expected late
“Our team is excited as we near initial data on AXS-02, our targeted, disease-specific, non-opioid product candidate for chronic pain,” said
About Complex Regional Pain Syndrome (CRPS)
CRPS is a debilitating condition characterized by severe, continuous, burning or throbbing pain in a limb. The excessive pain is accompanied by changes in skin color, temperature and/or swelling. It is considered to be one of the most painful conditions, results in loss of physical function, and can lead to significant and sometimes permanent disability. There is currently no medication approved for the treatment of CRPS.
About Knee Osteoarthritis (OA) associated with Bone Marrow Lesions (BMLs)
Knee OA is a disorder characterized by periarticular bone changes, progressive loss of articular cartilage, joint space narrowing, and eventual total joint failure. It is clinically manifested by knee pain, significant physical disability, and reduced quality of life. BMLs are regions of increased signal intensity on magnetic resonance imaging (MRI) of the knee in patients with knee OA. BMLs are strongly associated with the presence and severity of knee pain, and predict disease severity and structural progression in patients with knee OA, based on published studies. Results of epidemiological studies suggest that there are approximately 7 million symptomatic patients in
About AXS-02
AXS-02 (disodium zoledronate tetrahydrate) is a potent osteoclast inhibitor being developed as an oral, targeted, non-opioid, potentially first-in-class therapeutic for chronic pain. AXS-02 is dosed once per week for 6 weeks and thereafter may have a duration of effect measured in months. AXS-02 has a high affinity for bone mineral, and reduces osteoclast activity by inhibiting the farnesyl pyrophosphate synthase (FPPS) enzyme. AXS-02 is being developed in three separate Phase 3 clinical programs: complex regional pain syndrome (CRPS), knee osteoarthritis (OA) associated with bone marrow lesions (BMLs), and chronic low back pain (CLBP) associated with Modic changes (MCs). Phase 3 trials are underway with AXS-02 in CRPS (the CREATE-1 study) and knee OA associated with BMLs (the COAST-1 study), and a Phase 3 trial is planned in CLBP. AXS-02 is an investigational product candidate not approved by the
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Forward Looking Statements
Certain matters discussed in this press release are “forward-looking statements”. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. In particular, the Company’s statements regarding trends and potential future results are examples of such forward-looking statements. The forward-looking statements include risks and uncertainties, including, but not limited to, the success, timing and cost of our ongoing clinical trials and anticipated clinical trials for our current product candidates, including statements regarding the timing of initiation and completion of the trials, futility analyses and receipt of interim results; the timing of and our ability to obtain and maintain
Axsome Contact:Mark Jacobson Vice President, OperationsAxsome Therapeutics, Inc. 25 Broadway , 9th FloorNew York, NY 10004 Tel: 212-332-3243 Email: mjacobson@axsome.com www.axsome.com