Biotech Acquisition Merger Partner Blade Therapeutics Announces Topline Data From Phase 1 Clinical Study Of Cudetaxestat, A Non-Competitive Autotaxin Inhibitor In Clinical Development For Idiopathic Pulmonary Fibrosis

Author: Benzinga Newsdesk | November 30, 2021 09:17am

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.

The study (NCT04814498) was designed to evaluate the effect of cudetaxestat on the pharmacokinetics of a combination of probe substrates for CYP450 enzymes in healthy volunteers. A standard cytochrome cocktail was used to probe for cytochrome 450 isoform activation or inhibition. In the trial, subjects demonstrated no alteration of plasma levels of substrates for cytochromes 3A4, 2B6, 1A2, and 2C9. The few interactions included weak inhibition of 2D6 and induction of 2C19. Cudetaxestat demonstrated a favorable safety and tolerability profile with no severe adverse events or drop-outs due to adverse events.

“We are pleased with these clinical data that add to our expanding knowledge base about the supportive safety and tolerability profiles of cudetaxestat,” said Wendye Robbins, M.D., president and CEO of Blade. “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.”

In addition to today’s announcement, the company has recently achieved the following milestones for cudetaxestat:

• Initiation of a phase 1 drug-drug interaction clinical study to assess the effect of cudetaxestat on the pharmacokinetics of two approved drugs for IPF – pirfenidone and nintedanib (click here);
• Orphan drug designation granted by the U.S. Food and Drug Administration (FDA) for cudetaxestat for the potential treatment of systemic sclerosis (SSc) (click here);
• Positive data from a preclinical in vivo drug-drug interaction study of cudetaxestat when co-administered at steady state with nintedanib (click here);
• Completion of phase 1 clinical study investigating the relative bioavailability of a new tablet formulation of cudetaxestat to the oral solution formulation (click here); and
• FDA activation of an Investigational New Drug application to investigate cudetaxestat in IPF (click here). 

Posted In: BIOT BIOTU