Atossa announces full enrollment of Phase 2 Karisma-Endoxifen trial

Atossa Therapeutics announced that it has reached full enrollment in the Company’s Karisma-Endoxifen clinical trial, the 240-person Phase 2 study investigating (Z)-endoxifen in premenopausal women with measurable mammographic breast density, MBD. Participants have been randomized to placebo, 1 mg, and 2 mg daily doses of (Z)-endoxifen and will be treated for six months, over the course of which mammograms are conducted to measure reduction in MBD. MBD change is used as a proxy for therapy response. “We are excited that the Karisma-Endoxifen study is fully enrolled and look forward to seeing data from the trial in the second half of 2024,” said Dr. Steven Quay, Atossa’s President and Chief Executive Officer. “While significant progress has been made in breast cancer treatment, the same cannot be said about breast cancer prevention, particularly in high-risk women. (Z)-endoxifen is currently being studied in two populations that are at high risk of developing breast cancer, women with elevated breast density and women with ductal carcinoma in situ. Both diagnoses are strong, independent predictors of breast cancer risk that we feel are modifiable with (Z)-endoxifen.”