By Chris Wack


Blade Therapeutics Inc. said Monday it has received feedback from the Food and Drug Administration regarding the progress to a new study for a fibrotic disease treatment.

The FDA response letter, regarding the end-of-phase 1 data package for cudetaxestat, outlined requirements for a proposed phase 2 PoC/dose ranging study for use of cudetaxestat in patients with idiopathic pulmonary fibrosis, the biopharmaceutical company said.

Cudetaxestat is an investigational non-competitive autotaxin inhibitor in clinical development for treatment of IPF and other fibrotic diseases.

Based on the FDA feedback, Blade plans to advance cudetaxestat into a 26-week global phase 2 trial in patients with IPF in the second quarter of 2022, pending completion of preclinical toxicology studies.

The placebo-controlled phase 2 trial would evaluate the safety and efficacy of cudetaxestat dosed as monotherapy or co-administered with an approved IPF therapy in patients with IPF.

The primary study endpoint is change from baseline to week 26 in forced vital capacity lung volume measured in milliliters and assessed by clinic spirometry throughout the study duration. A blinded interim analysis would be conducted at 13 weeks after completion of enrollment to assess biomarkers.

The study is expected to enroll 200 patients across 90 sites in the U.S., Europe, and Asia-Pacific.


Write to Chris Wack at chris.wack@wsj.com


(END) Dow Jones Newswires

04-04-22 0856ET