The requirements for a phase 2 PoC/dose-ranging study of cudetaxestat for patients with idiopathic pulmonary fibrosis (IPF) have been outlined by the US Food and Drug Administration (FDA), according to a press release by Blade Therapeutics. Pending preclinical toxicity studies, the company will carry out the trial in the second quarter of 2022.
“Taking a stepwise approach through multiple phase 1 trials provided significant new knowledge and confidence in the safety profile of cudetaxestat,” Wendye Robbins, MD, president and chief executive officer of Blade Therapeutics said.
“We are now ready to advance cudetaxestat into a phase 2 clinical study that reflects the clinical treatment needs of patients with IPF.”
The phase 2 trial, a randomized, double-blind, placebo-controlled study, aims to assess the safety and efficacy of 3 different dosages of cudetaxestat, an investigational noncompetitive, reversible inhibitor of autotaxin, as monotherapy or combined therapy with pirfenidone or nintedanib.
Read more about IPF therapies
In phase 1 studies, cudetaxestat has been shown to be well-tolerated and to have direct antifibrotic activity, leading to Orphan Drug Designation for IPF and also for systemic sclerosis. It is not yet approved by the FDA for commercial use.
Blade Therapeutics, a biopharmaceutical company focused on developing therapies for fibrotic and neurodegenerative conditions, will enroll approximately 200 patients from 90 centers in Europe, the US, and the Asia-Pacific regions.
As assessed by spirometry, baseline changes in forced vital capacity lung volume in mL over a 26-week period represent the primary study endpoint. At 13 weeks, a blinded interim analysis will evaluate specific biomarkers including lysophosphatidic acid target engagement, PRO-C3, and PRO-C6.
Blade Therapeutics announces feedback from FDA on end-of-phase 1 data package. News release. Blade Therapeutics; April 4, 2022.