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STX-100 Phase 2 Trial in Idiopathic Pulmonary Fibrosis Now Recruiting Patients
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Fibrosis is wound repair gone bad. It is a consequence of chronic tissue injury. Ongoing cycles of injury and repair, usually playing out over years or decades, lead to accumulation of scar tissue in an organ and disruption of normal tissue architecture and function. In short, the organ fails.

Fibrosis is the final common pathway in virtually all forms of chronic organ failure. The cell and molecular biology of fibrosis is similar whether it occurs in kidney, liver, lung or elsewhere and whether its cause is viral, chemical, physical or inflammatory. Fibrosis results from the excessive activity of fibroblasts, in particular from an activated form called the myofibroblast. The biology of these cells is well understood and there is consensus among experts that pharmacological attenuation of myofibroblast activity ought to slow or perhaps even reverse disease progression, thereby preserving organ function and prolonging healthy life.

What's missing is the clinical proof — evidence that agents that target the myofibroblast have a meaningful clinical effect in humans. That's the challenge we're taking on at Stromedix.

STX-100
STX-100 is Stromedix's first clinical candidate. It is a humanized monoclonal antibody targeting integrin αvβ6 in-licensed from Biogen Idec. STX-100 exhibits significant anti-fibrotic activity in preclinical models of lung, kidney and liver disease. Stromedix intends to develop this novel molecule in multiple clinical indications. STX-100 has successfully completed Phase 1 clinical testing.


Selected Publications
Hahm et al. αvβ6 integrin regulates renal fibrosis and inflammation in alport mouse.  Am J Pathol. 2007; 170: 110-125.

Horan et al. Partial inhibition of integrin αvβ6 prevents pulmonary fibrosis without exacerbating inflammation. Am J Respir Crit Care Med. 2008; 177(1):56-65. Epub 2007 Oct 4

Puthawala et al. Inhibition of integrin αvβ6, an activator of latent transforming growth factor-beta, prevents radiation-induced lung fibrosis. Am J Respir Crit Care Med. 2008; 1;177(1):82-90. Epub 2007 Oct 4.

Ganter et al. Interleukin-1beta causes acute lung injury via alphavbeta5 and alphavbeta6 integrin-dependent mechanisms. Circ Res 2008; 102(7):804-812. Epub 2008 Feb 14.

Xu et al. Lysophosphatidic acid induces alphavbeta6 integrin-mediated TGF-beta activation via the LPA2 receptor and the small G protein G alpha(q). Am J Pathol 2009; 174(4): 1264-1279. Epub 2009 Jan 15.

Van Aarsen et al. Antibody-mediated blockade of integrin alphavbeta6 inhibits tumor progression in vivo by a transforming growth factor-beta-regulated mechanism. Cancer Res 2008; 68(2): 561-570.

Wang et al. Role of αvβ6 integrin in acute biliary fibrosis. Hepatology 2007; 46(5):1404-12.

Popov et al. Role of αvβ6 integrin in acute biliary fibrosis. Hepatology 2007; 46(5):1404-12.

Trevillian  et al. αvβ6 Integrin expression in diseased and transplanted kidneys. Kidney Int 2004; 66(4): 1423-1433.

Weinreb et al. Function-blocking integrin αvβ6 monoclonal antibodies. J. Biol. Chem. 2004; 279(17): 17875-17887.

Munger et al. The integrin αvβ6 binds and activates latent TGF-β1: a mechanism for regulating pulmonary inflammation and fibrosis. Cell 1999; 96: 319-328.


  
STX-100 is Stromedix's first clinical candidate and is being developed for the treatment of idiopathic pulmonary fibrosis.

x Humanized monoclonal antibody to integrin αvβ6
x Completed phase 1 clinical testing
x Provides localized, injury-specific inhibition of TGF-β activation
x Significant anti-fibrotic activity in preclinical models of lung, kidney and liver disease
x Broad therapeutic utility in chronic organ failure, acute organ failure and cancer
Phase 2 clinical trial for patients with idiopathic pulmonary fibrosis now open. More information at ClinicalTrials.gov.