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United States

Profile: Axsome Therapeutics Inc (AXSM.A)

AXSM.A on American Stock Exchange

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24 May 2019
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Axsome Therapeutics, Inc., incorporated on January 12, 2012, is a clinical-stage biopharmaceutical company. The Company is engaged in developing therapies for the management of central nervous system (CNS) disorders, including pain. It operates in the business of developing novel therapies for the management of CNS disorders segment. The Company's product candidate portfolio includes two late-stage candidates, AXS 02 and AXS 05, which the Company is developing for multiple indications. The Company is also developing AXS 06 for the treatment of chronic pain disorders. AXS 06 is in preclinical development.

AXS 02

The Company's product candidate, AXS 02, contains disodium zoledronate tetrahydrate. AXS-02 is an oral, targeted, non opioid therapeutic for chronic pain. AXS 02 is an inhibitor of osteoclasts, which are bone remodeling cells that break down bone tissue. The Company is developing AXS 02 for the treatment of pain in over three conditions, such as complex regional pain syndrome (CRPS); knee osteoarthritis (OA) associated with bone marrow lesions (BMLs), and chronic low back pain (CLBP), associated with type I, or mixed type I and type II Modic changes (MCs). The Company initiated a Phase III trial with AXS 02 for the treatment of pain in patients with CRPS, which it refers to as the CREATE 1 study. AXS 02 is granted Orphan Drug Designation by the United States Food and Drug Administration (FDA) and Orphan Medicinal Product Designation by the European Medicines Agency (EMA) for the treatment of CRPS. The Company focuses on initiating a Phase III clinical trial with AXS-02 for the treatment of pain in patients with knee OA associated with BMLs, which it refers to as the COAST 1 study. The Company focuses on initiating a Phase III clinical trial with AXS 02 for the treatment of CLBP associated with MCs.

AXS 05

The Company's product candidate, AXS 05, is a fixed dose combination of dextromethorphan (DM) and bupropion. The Company is developing AXS 05 for the treatment of over two conditions, such as treatment resistant depression (TRD), and agitation in patients with Alzheimer's disease (AD). DM is active at multiple CNS receptors but is rapidly metabolized in humans. As a result, it is difficult to attain potential therapeutic plasma levels of DM when it is dosed as a single agent. AXS 05 uses bupropion as a drug delivery method to inhibit DM metabolism and increase its bioavailability. The Company initiated randomized, double-blind, active-controlled trial to assess the efficacy and safety of AXS 05 in the treatment of TRD, which it refers to as the STRIDE-1 study.

The Company competes with Eli Lilly and Company.

Company Address

Axsome Therapeutics Inc

200 Broadway 3rd Floor
NEW YORK   NY   10038-2542
P: +1212.3323241
F: +1302.6365454

Company Web Links