- Thinly traded micro cap Axsome Therapeutics (AXSM -10.9%) is down on more than double normal volume, albeit on turnover of only 384K shares, in apparent response to its announcement of the timing of interim analyses of two Phase 3 clinical trials assessing lead product candidate AXS-02, one of which represents a delay from a previous announcement.
- The Independent Data Monitoring Committee (IDMC) will perform the analyses on the CREATE-1 study, evaluating AXS-02 in patients with complex regional pain syndrome, and COAST-1, in patients with knee osteoarthritis associated with bone marrow lesions. Both studies will be reviewed during the same meeting with reports expected by year-end or early January 2018.
- The company previously announced that the interim analysis on COAST-1 would be completed in Q3.
- AXS-02 (disodium zoledronate tetrahydrate) is an orally administered non-opioid pain therapeutic that inhibits bone turnover and localizes to regions of increased turnover (lesions in the bone marrow). It works by inhibiting an enzyme called farnesyl pyrophosphate synthase which, in turn, reduces the activity of bone cells called osteoclasts, cells that break down bone tissue in the critical process of bone regeneration.
- Previously: Axsome's late-stage study underway assessing lead product candidate in arthritis-associated knee pain (March 28, 2016)
- Now read: Deciphera Pharmaceuticals Seeks 0 Million IPO
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