Atossa says Phase 2 KARISMA trial shows Endoxifen cuts mammographic breast density 19.3%

Atossa Therapeutics, Inc.

Atossa Therapeutics, Inc.

ATOS

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  • Atossa Therapeutics flagged peer-reviewed publication of results from KARISMA Endoxifen trial in Journal of National Cancer Institute, with results already presented via publication.
  • Phase 2 study in healthy premenopausal women showed low-dose oral endoxifen reduced mammographic breast density versus placebo, supporting its positioning as potential breast cancer risk-reduction option.
  • Lower dose delivered meaningful effect with tolerability broadly similar to placebo, while higher dose drove more treatment-related discontinuations, shaping dose selection for future development.
  • Program rationale centers on bypassing tamoxifen metabolism variability by dosing active metabolite directly, aiming to improve predictability and long-term acceptability in prevention setting.
  • Next step remains clinical work to determine whether endoxifen lowers breast cancer incidence in higher-risk women, beyond biomarker changes.


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