The US Food and Drug Administration (FDA) has activated the Investigational New Drug Application for cudetaxestat, a treatment being developed by Blade Therapeutics to treat idiopathic pulmonary fibrosis (IPF).
Wendye Robbins, MD, president and CEO of Blade Therapeutics, said, “We are excited about this important regulatory step that supports the development path for cudetaxestat.”
IPF is characterized by uncontrolled, progressive lung fibrosis, which disrupts pulmonary function and leads to high morbidity and mortality.
Read more about IPF treatment
Cudetaxestat is a noncompetitive autotaxin inhibitor. Autotaxin is a key enzyme responsible for generating lysophosphatidic acid (LPA). In the case of epithelial cell/tissue damage, autotaxin levels increase and lead to excessive LPA. This triggers a cascade of events that lead to fibrosis.
Research has shown that cudetaxestat has direct antifibrotic activity. The results of a phase 1 clinical trial have also shown that it is well tolerated.
With the activation of the Investigational New Drug Application, the FDA has allowed Blade Therapeutics to initiate the clinical investigation of cudetaxestat as a potential treatment for IPF.
The company can now start its planned phase 1 clinical trial to investigate the effect of cudetaxestat on the pharmacokinetics of pirfenidone and nintedanib, 2 IPF treatments approved by the FDA, in healthy volunteers. The trial will also evaluate the safety and tolerability of cudetaxestat on its own and when administered with either nintedanib or pirfenidone. It aims to recruit 86 participants, aged 18 to 55 years, and had been estimated to start in July 2021. It is currently estimated to be completed in January 2022.
The company will use the results of this trial to design a phase 2 study to evaluate the safety and efficacy of the treatment in patients with IPF. This phase 2 trial is anticipated to start in the first half of 2022.
Blade Therapeutics is currently also testing cudetaxestat in 2 other phase 1 clinical trials. The first is investigating the relative bioavailability of a new tablet formulation of the treatment, compared with the current oral solution formulation. The second is evaluating the effect of the treatment on the pharmacokinetics of a combination of probe substrates for cytochrome P450 enzymes.
Blade Therapeutics announces FDA activation of IND application to investigate cudetaxestat, a non-competitive autotaxin inhibitor, in idiopathic pulmonary fibrosis (IPF). News release. Blade Therapeutics; August 25, 2021.
Dedicated drug-drug interaction (DDI) study in healthy volunteers. ClinicalTrials.gov. June 25, 2021. Accessed August 27, 2021.