Atossa Therapeutics, Inc. (ATOS), Wednesday announced data from its Phase 2 KARISMA-Endoxifen trial, evaluating safety and tolerability of the drug in reducing mammographic breast density or MBD in pre-menopausal women at risk of developing breast cancer.
The randomized, double-blind, placebo-controlled study involved 240 premenopausal women aged 40-55 divided into three arms - placebo, 1 mg, or 2 mg of daily oral Z-endoxifen for six months.
The company found that the 1 mg dose of Z-endoxifen reduced MBD by 17.3 percentage points, whereas the 2 mg dose achieved a reduction of 23.5 percentage points. Meanwhile, a minimal change of 0.27 percentage points was noted in the placebo group.
However, the 2 mg dose was associated with higher rates of hot flashes, night sweats, and vaginal discharge.
The findings suggested that Z-endoxifen could be used as a preventative therapy for women with dense breast tissue.
Currently, Atossa's stock is trading at $1.29, up 2.78 percent on the Nasdaq.
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