Endeavor BioMedicines said its Phase 2b WHISTLE-PF trial of taladegib (ENV-101) met its primary endpoint and multiple key secondary endpoints in people with idiopathic pulmonary fibrosis (IPF).
The 24-week, placebo-controlled trial enrolled 213 patients. The company reported statistically significant improvement in percent-predicted forced vital capacity (ppFVC), a measure of lung function, versus placebo.
Endeavor also reported favorable differences in total lung capacity and CT-based measures of interstitial lung disease and fibrosis. It says these findings suggest taladegib may reduce fibrosis while improving lung function.
The detailed results have not yet been presented publicly; Endeavor said they will be shared at a future medical meeting. The company plans to discuss a Phase 3 strategy with the FDA.
Sources:
Top News | Endeavor BioMedicines
Clinical-stage Biotechnology Company | Endeavor BioMedicines
Endeavor BioMedicines Successfully Completes Phase 2a Trial of ...
Press Releases - Endeavor BioMedicines
Endeavor's Phase IIb IPF study of taladegib meets endpoints
Endeavor Hedgehog inhibitor has potential to shake up IPF space
Endeavor BioMedicines' IPF drug meets Phase 2b primary ...
Taladegib Results Accepted at European Respiratory Society ...