Atossa Therapeutics Inc (NASDAQ:ATOS) announced that 170 patients have been enrolled across its ongoing Phase 2 Karisma-Endoxifen study of its oral formulation of (Z)-endoxifen in premenopausal women with measurable breast density.
The company said it expects the trial to be fully enrolled in the fourth quarter of 2023.
Participants in the trial receive daily doses of (Z)-endoxifen, the most active metabolite of the Food and Drug Administration (FDA)-approved Selective Estrogen Receptor Modulator (SERM) tamoxifen, for six months over the course of which mammograms are conducted to measure reduction in mammographic breast density (MBD).
Patients will also have a mammogram at 24 months to evaluate the durability of the MBD changes, Atossa noted.
“We are excited about the progress we’ve made in our mammographic breast density study and look forward to fully enrolling the trial later this year and seeing data in 2024,” Atossa CEO Steven Quay said in a statement.
“There are currently no approved treatments for women diagnosed with elevated breast density. We feel (Z)-endoxifen has the potential to reduce breast density in this patient population, which would make mammograms more reliable and decrease the risk that these women will develop cancer in their lifetime.”
Atossa Therapeutics is a clinical-stage biopharmaceutical company developing innovative medicines in areas of significant unmet medical need in oncology with a focus on breast cancer.
It is developing a proprietary oral formulation of (Z)-endoxifen that does not require liver metabolism to achieve therapeutic concentrations and is encapsulated to bypass the stomach as acidic conditions in the stomach convert a greater proportion of (Z)-endoxifen to the inactive (E)-endoxifen.
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