Autotaxin

Blade Therapeutics Presents Analyses from Phase 1 and Preclinical Studies of Cudetaxestat at the European Respiratory Society International Congress 2022

Retrieved on: 
Sunday, September 4, 2022
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The data were featured in a poster (abstract #PA459) presented today at the European Respiratory Society (ERS) International Congress 2022, which is taking place in Barcelona, Spain, from September 4-6, 2022.

Key Points: 
  • The data were featured in a poster (abstract #PA459) presented today at the European Respiratory Society (ERS) International Congress 2022, which is taking place in Barcelona, Spain, from September 4-6, 2022.
  • Data analyses were included from a battery of preclinical studies that assessed the potency and activity of cudetaxestat, and four Phase 1 studies of healthy volunteers (N=216) that evaluated safety/tolerability along with pharmacokinetic (PK) and pharmacodynamic (PD) activity.
  • Results of analyses from preclinical studies showed that cudetaxestat maintained potency against its target in vitro regardless of substrate (lysophosphatidylcholine, or LPC) concentration and demonstrated significant anti-fibrotic activity in multiple in vivo preclinical models.
  • For additional information about the ERS International Congress 2022, please visit the website .

Bridge Biotherapeutics Receives FDA Authorization to Proceed with Phase 2 Study of BBT-877

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Tuesday, August 16, 2022
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The U.S. FDA finally approved the final protocol, and confirmed the advancement of Phase 2 clinical study of BBT-877.

Key Points: 
  • The U.S. FDA finally approved the final protocol, and confirmed the advancement of Phase 2 clinical study of BBT-877.
  • "We're excited to continue the clinical development of BBT-877 in order to address unmet medical needs of IPF," said James Lee, founder and CEO of Bridge Biotherapeutics.
  • Bridge plans to initiate the 24-week Phase 2 clinical study later this year.
  • BBT-877, an experimental autotaxin inhibitor, demonstrated LPA inhibition of up to 90 percent in multiple-ascending dose cohorts of the Phase 1 study.

iOnctura Presents Data at AACR Demonstrating its Unique Mechanism of Action for Clinical Stage ATX Inhibitor IOA-289

Retrieved on: 
Friday, April 8, 2022
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The data will be shared via a poster (#2636) at the annual meeting of the American Association for Cancer Research (AACR) taking place on April 8-13, 2022 in New Orleans, Louisiana.

Key Points: 
  • The data will be shared via a poster (#2636) at the annual meeting of the American Association for Cancer Research (AACR) taking place on April 8-13, 2022 in New Orleans, Louisiana.
  • Autotaxin (ATX) is a secreted glycoprotein that hydrolyzes Lysophosphatidylcholine (LPC) to Lysophosphatidic Acid (LPA).
  • The AACR presentation demonstrates that by preventing LPA production, IOA-289 has a direct effect on pancreatic cancer cell lines (PDAC cells), inhibiting their growth in vitro.
  • LPA also modulates the tumor stroma which enables tumors to evade host immunity and impairs patients responses to therapy.

Blade Therapeutics Announces Feedback from FDA on End-of-Phase 1 Data Package

Retrieved on: 
Monday, April 4, 2022
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The FDA response letter outlined requirements for a proposed phase 2 PoC/dose ranging study for use of cudetaxestat in patients with IPF.

Key Points: 
  • The FDA response letter outlined requirements for a proposed phase 2 PoC/dose ranging study for use of cudetaxestat in patients with IPF.
  • We are pleased with the guidance provided by the FDA, said Wendye Robbins, M.D., president and CEO of Blade.
  • Available data from completed phase 1 studies in healthy volunteers showed that cudetaxestat was well tolerated with a demonstrated pharmacokinetic/pharmacodynamic correlation and biomarker activity.
  • Cudetaxestat is an investigational medicine that is not approved for commercial use by the FDA or any other regulatory authority.

Blade Therapeutics Announces Successful Completion of Phase 1 Clinical Study that Evaluated Co-Administration of Cudetaxestat with Either of Two Approved Therapies for Idiopathic Pulmonary Fibrosis

Retrieved on: 
Wednesday, January 12, 2022
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There is a huge unmet need for new antifibrotic therapies which can complement current treatments and provide greater benefit for patients.

Key Points: 
  • There is a huge unmet need for new antifibrotic therapies which can complement current treatments and provide greater benefit for patients.
  • This phase 1 study of cudetaxestat provides a clear path to proceed into a phase 2 study that addresses this need for novel therapeutics that may be administered together with current anti-fibrotic drugs.
  • We look forward to discussing these data with regulatory authorities as we proceed toward the next phase of clinical development for cudetaxestat.
  • The company plans to start a phase 2 clinical study of cudetaxestat in patients with IPF in the second quarter of 2022.

Blade Therapeutics Announces Positive Topline Data from Phase 1 Clinical Study of Cudetaxestat, a Non-Competitive Autotaxin Inhibitor in Clinical Development for Idiopathic Pulmonary Fibrosis

Retrieved on: 
Tuesday, November 30, 2021
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Blade Therapeutics, Inc. (Blade), a biopharmaceutical company focused on developing cutting-edge treatments for debilitating fibrotic and neurodegenerative diseases, today announced positive topline data from a phase 1 drug-drug interaction clinical study of cudetaxestat, an investigational non-competitive autotaxin inhibitor in clinical development for IPF.

Key Points: 
  • Blade Therapeutics, Inc. (Blade), a biopharmaceutical company focused on developing cutting-edge treatments for debilitating fibrotic and neurodegenerative diseases, today announced positive topline data from a phase 1 drug-drug interaction clinical study of cudetaxestat, an investigational non-competitive autotaxin inhibitor in clinical development for IPF.
  • Cudetaxestat demonstrated a favorable safety and tolerability profile with no severe adverse events or drop-outs due to adverse events.
  • This study continues the momentum of our development program and supports advancing cudetaxestat in the anticipated patient populations.
  • Blade remains on track with plans to initiate a phase 2 study of cudetaxestat in patients with IPF in the first half of 2022.

iOnctura Presents Compelling Preclinical Data on its Clinical Stage Autotaxin Inhibitor IOA-289 at SITC

Retrieved on: 
Friday, November 12, 2021
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The expression of both autotaxin and LPA is elevated in most solid tumors, with corresponding increases measurable in patients plasma.

Key Points: 
  • The expression of both autotaxin and LPA is elevated in most solid tumors, with corresponding increases measurable in patients plasma.
  • The data presented at SITC showed that IOA-289 is able to dose-dependently reduce LPA levels, potently modulate fibrotic processes and restore T cell migration in preclinical models.
  • iOnctura plans to advance IOA-289 into a Phase 1 clinical study in pancreatic cancer, AION-01, in the first half of 2022.
  • The poster presentation at SITC entitled A novel autotaxin inhibitor, IOA-289, modulates tumor, immune and stromal cell function and has monotherapy activity in fibrotic cancer models, is available at the SITC platform and iOncturas website .

Blade Therapeutics Initiates Additional Phase 1 Clinical Study of Cudetaxestat, a Non-Competitive Autotaxin Inhibitor in Clinical Development for Idiopathic Pulmonary Fibrosis

Retrieved on: 
Monday, October 18, 2021
Health, FDA, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Myofibroblast, Interstitial lung disease, Matrix, HIV disease progression rates, LPA, Systemic scleroderma, Lung, LinkedIn, Achievement, Autotaxin, Liver, Fibrosis, Mortality, Disease, Enzyme, FDA, Institute of Liver and Biliary Sciences, Scleroderma, NASH, Clinical trial, Patient, Aggregation, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Neurodegeneration, Food, CEO, IPF, Safety, CYP450, Therapy, Pharmacokinetics, Kidney, Pharmaceutical industry

Blade continues to make progress advancing the clinical development program for cudetaxestat, said Wendye Robbins, M.D., president and CEO of Blade.

Key Points: 
  • Blade continues to make progress advancing the clinical development program for cudetaxestat, said Wendye Robbins, M.D., president and CEO of Blade.
  • We are encouraged by the recent achievement of several development milestones for cudetaxestat and look forward to executing on the planned path ahead.
  • The study remains on track and is expected to be completed in the fourth quarter of 2021.
  • In addition, autotaxin levels correlate with fibrosis severity in various liver diseases (e.g., nonalcoholic fatty liver disease/nonalcoholic steatohepatitis (NASH)).

Blade Therapeutics Announces FDA Orphan Drug Designation Granted to Cudetaxestat for Treatment of Systemic Sclerosis

Retrieved on: 
Thursday, October 14, 2021
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Blade Therapeutics, Inc. (Blade or the company), a biopharmaceutical company focused on developing cutting-edge treatments for debilitating fibrotic and neurodegenerative diseases, today announced that the FDA has granted orphan drug designation for cudetaxestat for the potential treatment of systemic sclerosis (SSc).

Key Points: 
  • Blade Therapeutics, Inc. (Blade or the company), a biopharmaceutical company focused on developing cutting-edge treatments for debilitating fibrotic and neurodegenerative diseases, today announced that the FDA has granted orphan drug designation for cudetaxestat for the potential treatment of systemic sclerosis (SSc).
  • There are limited options and high medical need for patients suffering from systemic sclerosis, said Daven Mody, PharmD, MBA, vice president of regulatory affairs with Blade.
  • Cudetaxestat received its first orphan drug designation in February 2021 for the potential treatment of IPF.
  • Cudetaxestat has been granted orphan drug designations in the treatment of IPF and SSc.

Blade Therapeutics Announces Positive Data from Preclinical Drug-Drug Interaction Study of Cudetaxestat, a Non-Competitive Autotaxin Inhibitor in Clinical Development for Idiopathic Pulmonary Fibrosis (IPF)

Retrieved on: 
Monday, September 20, 2021
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Nintedanib, a medicine from Boehringer Ingelheim, is approved by the U.S. Food and Drug Administration (FDA) for the treatment of IPF.

Key Points: 
  • Nintedanib, a medicine from Boehringer Ingelheim, is approved by the U.S. Food and Drug Administration (FDA) for the treatment of IPF.
  • We believe that these are important data that help inform our step-wise approach to advance the clinical development program for cudetaxestat, said Wendye Robbins, M.D., president and CEO of Blade.
  • In the preclinical study, 18 male rats received daily oral administration with nintedanib only during study days one through four.
  • Blade plans to further analyze data from this study and intends to submit study data for potential publication in a peer-reviewed scientific journal.