Blade Therapeutics Presents Preclinical Data Highlighting Differentiating Characteristics of Cudetaxestat at the American Thoracic Society 2022 International Conference
Blade Therapeutics announced promising preclinical results for cudetaxestat, an investigational drug aimed at treating idiopathic pulmonary fibrosis (IPF). The findings reveal cudetaxestat's direct anti-fibrotic effects in a lung fibrosis model and its ability to inhibit autotaxin non-competitively, maintaining potency in fibrotic conditions. The company is set to initiate a phase 2 clinical trial in Q2 2022, showcasing its commitment to advancing treatments for fibrotic diseases. Additionally, the drug has received orphan drug designation, emphasizing its potential significance in this therapeutic area.
- Cudetaxestat demonstrated direct anti-fibrotic effects on multiple biomarkers in preclinical lung fibrosis models.
- The drug maintained potency despite elevated substrate concentrations found in fibrotic tissues.
- The company plans to start a phase 2 clinical trial for cudetaxestat in patients with IPF in Q2 2022.
- Cudetaxestat has been granted orphan drug designations for IPF and systemic sclerosis.
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- Cudetaxestat displayed direct anti-fibrotic effects on multiple biomarkers in a preclinical lung fibrosis model
- Non-competitive autotaxin inhibition by cudetaxestat maintained potency in the presence of elevated substrate concentrations found in fibrotic tissues
- Company on track to start phase 2 clinical trial of cudetaxestat in patients with idiopathic pulmonary fibrosis (IPF) in second quarter of 2022
"We are encouraged by the profile of cudetaxestat, which we believe is a clearly differentiated molecule based on its direct anti-fibrotic activity and non-competitive inhibition of autotaxin,” said
Preclinical in vitro analyses assessed the potency of cudetaxestat and a competitive autotaxin inhibitor (GLPG-1690) under varying concentrations of a substrate (lysophosphatidylcholine or “LPC”) found in fibrotic tissues. Additional evaluations using mouse models assessed the impact of cudetaxestat on multiple biomarkers of lung fibrosis. Key findings include the following:
- Non-competitive autotaxin inhibition with cudetaxestat maintained biochemical potency in the presence of elevated LPC concentrations;
- In a mouse model of lung fibrosis, cudetaxestat displayed direct anti-fibrotic activity (reduced αSMA, Col1A1 expression, reduced fibrosis, and assembled collagen); and
- Inhibition of the autotaxin/lysophosphatidic acid pathway by cudetaxestat significantly reduced activation (gene expression) of several key pro-fibrotic pathways.
Study data were presented in a poster (#815 – PDF available here) titled “Differentiating Characteristics of Cudetaxestat (BLD-0409), a
For additional information about the ATS 2022
Cudetaxestat
Cudetaxestat (BLD-0409), a non-competitive, reversible inhibitor of autotaxin, has demonstrated direct anti-fibrotic activity and differentiating preclinical and biochemical characteristics which support the potential for a treatment profile in lung and liver fibrosis. Available data from four completed phase 1 studies in more than 200 healthy volunteers showed that cudetaxestat was well tolerated with a demonstrated pharmacokinetic/pharmacodynamic correlation and biomarker activity. Cudetaxestat has been granted orphan drug designations in the treatment of IPF and systemic sclerosis. Cudetaxestat is an investigational medicine that is not approved for commercial use by the FDA or any other regulatory authority.
Autotaxin
Pro-fibrotic processes are stimulated by autotaxin, a key enzyme responsible for generating the potent signaling lipid lysophosphatidic acid (LPA). Excessive autotaxin levels and activity play a central role in various fibrotic diseases and occur in response to epithelial cell/tissue damage, leading to elevated levels of LPA. LPA binds to LPA receptors on myofibroblasts triggering a signaling cascade that leads to myofibroblast activation/differentiation. Activated myofibroblasts produce extracellular matrix proteins that make up the fibrotic lesion (organ/tissue scarring). Increased autotaxin levels and activity are associated with liver, lung, kidney, and skin fibrosis. In addition, autotaxin levels correlate with fibrosis severity in various liver diseases (e.g., nonalcoholic fatty liver disease/nonalcoholic steatohepatitis (NASH)). Inhibition of the autotaxin-LPA pathway has been clinically validated in IPF.
Fibrosis
Fibrosis is a complex, pathologic process involving the development of organ/tissue scarring characterized by deposition of extracellular matrix proteins that develop in response to aberrant cell/tissue damage. Excessive fibrosis disrupts normal architecture and function of organs/tissues. Later-stage fibrotic disease is marked by poor outcomes and high morbidity and mortality. Diseases characterized by uncontrolled, progressive fibrosis include IPF, interstitial lung disease, and NASH. New well-tolerated therapies that provide robust attenuation of disease progression are needed to address the high burden of fibrotic diseases.
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