Atossa Therapeutics announces support for Phase 2 SMART study

Atossa Therapeutics announced support for a new Phase 2 study designed to validate an innovative, artificial intelligence driven, breast cancer risk assessment model. The SMART study will test an individualized, imaging-based screening model designed to identify women with the highest risk of developing breast cancer in the next two years. If the model is validated for therapeutic use, it could serve as the foundation for a future, Phase 3, trial investigating (Z)-endoxifen in the breast cancer prevention setting. Atossa is a clinical stage biopharmaceutical company developing innovative medicines in areas of significant unmet medical need in oncology with a focus on breast cancer. The SMART study is expected to enroll 70,000 women who will join following their regularly scheduled bi-annual mammogram, the cost of which is covered by the nationalized healthcare system in Sweden. Mammogram results and additional assessment data will be analyzed by a proprietary algorithm known as the Profound Artificial Intelligence Risk Assessment Model, which will determine each participant’s risk of developing breast cancer in the next two years. The approximately 20% of women who have the highest risk of developing breast cancer in the next two years will be randomized into two arms. In the intervention arm, the approximately 7,000 women at highest risk will have a contrast enhanced mammogram. CEM has proven to better identify cancers that were missed on the regular mammogram because of dense breast tissue. Participants in the control arm will screen according to current guidelines, that is, return in two years for their next regularly scheduled mammogram. The study will measure how many women across both arms develop breast cancer over the next two years, which will determine the predictive power of the proprietary algorithm.