Sermonix announces FDA acceptance of IND application for lasofoxifene
Sermonix Pharmaceuticals announced that the U.S. Food and Drug Administration accepted the company's Investigational New Drug application, indicating that Sermonix may proceed directly to a Phase 2 clinical study in the personalized medicine arena involving its lead investigational drug, lasofoxifene. The open-label, randomized, multi-center study is expected to begin enrollment in early 2019 and will evaluate the activity of oral lasofoxifene versus intramuscular fulvestrant for the treatment of postmenopausal women with locally advanced or metastatic estrogen receptor-positive (ER+)/HER2- breast cancer with an ESR1 mutation. A large amount of clinical data from earlier non-oncology development, along with new, compelling preclinical data have enabled Sermonix to commence directly into the Phase 2 study. The study will include postmenopausal women with ESR1 mutations, identified using a liquid biopsy clinical trial assay, who have progressed after aromatase inhibitor and CDK 4/6 inhibitor therapy. ESR1 mutations occur in up to 40 percent of women with metastatic breast cancer and may confer a worse prognosis and poor response to currently available endocrine treatments. Lasofoxifene is an investigational, nonsteroidal selective estrogen receptor modulator, which Sermonix licensed from Ligand Pharmaceuticals.