SAN DIEGO – September 6, 2023 – Endeavor BioMedicines, a clinical-stage company targeting the drivers of fibrosis and oncology, today announced that the company has completed enrollment in its Phase 2a clinical trial to evaluate the safety and efficacy of ENV-101 (taladegib) for the treatment of idiopathic pulmonary fibrosis (IPF). ENV-101 is a small-molecule inhibitor of the Hedgehog (Hh) signaling pathway, which plays a critical role in IPF disease pathology.
“Completing enrollment in the ENV-101 IPF study brings us one step closer to delivering an urgently needed therapy with the potential to treat the underpinnings of the disease and halt the progression of fibrosis,” said John Hood, Ph.D., Co-Founder, CEO and Chairman, Endeavor BioMedicines. “This enrollment milestone is an important achievement, and we look forward to reporting topline results in Q1 of 2024. I would like to thank the patients participating and the clinical trial sites for working tirelessly to advance the study to this point.”
The Phase 2a clinical trial is a randomized, placebo-controlled, multi-center study, designed to assess the efficacy and safety of ENV-101 as a monotherapy in subjects with mild to moderate IPF. The study is being conducted in the Asia-Pacific region as well as Canada and Mexico and enrolled 41 participants. The primary endpoints of the trial include change from baseline in frequency and severity of adverse events, as well as change in key vital sign measurements. Secondary endpoints include change in forced vital capacity (FVC) and other measures of lung function.
Additional information on the trial can be found at www.clinicaltrials.gov using the identifier NCT04968574.
ENV-101: Targeting the Hedgehog Signaling Pathway in Pulmonary Disease
ENV-101 is an agent originally developed to target Hedgehog driven cancers that has been evaluated in approximately 200 subjects and yielded best in class safety and target inhibition in man. The Hedgehog pathway is a developmental pathway not normally active in adults. In IPF, as part of the tissue remodeling process, the Hedgehog pathway is upregulated inducing the appearance of myofibroblasts via epithelial mesenchymal transition. Myofibroblasts are the cells that deposit fibrotic matrix and contract the lung leading to the inelastic, contracting, poorly perfused lungs responsible for IPF patient morbidity and mortality. Selectively inhibiting this pathway in lung tissue induces myofibroblast apoptosis, thereby eliminating the key cellular driver of IPF.
About Endeavor BioMedicines
Endeavor BioMedicines is a clinical stage company targeting the drivers of fibrosis and oncology. We combine best-in-class therapeutics with an evolving understanding of terminal diseases to develop medicines with the potential to reverse severe health conditions. Our lead program, ENV-101, is a Hedgehog signaling inhibitor with demonstrated clinical activity that we are investigating in IPF. At Endeavor, we are an innovative and focused team that has come together to live up to our name and bold mission: to help patients feel better and live longer. Please visit us on our website at www.endeavorbiomedicines.com and on our LinkedIn and X (formerly Twitter) pages.