Axsome Therapeutics, Inc., a clinical stage biopharmaceutical company, announced that the US Patent and Trademark Office has issued a patent (US Patent No. 9,211,257), which provides coverage for AXS-02, one of Axsome’s late-stage product candidates.

The patented claims cover the use of zoledronic acid, the active moiety in AXS-02, for the treatment of bone marrow lesions (BMLs) of the knee.

AXS-02 is in development for the pain of knee osteoarthritis associated with BMLs. The term of the issued patent extends into 2033.

Axsome Therapeutics, is a clinical stage biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders. Axsome’s product candidate portfolio includes two late-stage candidates, AXS-02 and AXS-05. AXS-02 is currently in a phase 3 trial in complex regional pain syndrome (CRPS), with additional phase 3 trials planned in knee osteoarthritis (OA) associated with bone marrow lesions (BMLs), and chronic low back pain (CLBP) associated with Modic changes (MCs). A phase 3 trial in treatment resistant depression (TRD) is currently planned with AXS-05.

AXS-02 and AXS-05 are investigational medications not approved by the FDA. The safety and efficacy of AXS-02 and AXS-05 have not yet been established.