Atossa Therapeutics (ATOS) Receives Approval from Swedish Regulators to Initiate Phase 2 Clinical Study of Oral Endoxifen to Reduce Mammographic Breast Density

Atossa Therapeutics, Inc. (Nasdaq: ATOS), a clinical-stage biopharmaceutical company seeking to discover and develop innovative medicines in oncology and infectious disease with a current focus on breast cancer and COVID-19, announces that it has received approval from the Swedish Medical Product Agency (MPA) to initiate a Phase 2 clinical study of its oral Endoxifen for the reduction of mammographic breast density (MBD). MBD is an emerging public health issue affecting more than 10 million women in the United States and many more worldwide. Studies conducted by others have shown that MBD reduces the ability of mammograms to detect cancer (sensitivity) and increases the risk of developing breast cancer. Additional studies show a correlation between reducing MBD and a reduction in the incidence of breast cancer.

“This is a critical milestone in the development of our oral Endoxifen,” commented Steven Quay, M.D., Ph.D., Atossa’s Chairman and CEO. “We now plan to commence the study as soon as restrictions for COVID-19 in Stockholm allow and we are encouraged that daily and weekly average COVID-19 cases have been steadily declining in Sweden over the past six weeks. If this trend continues, we expect to initiate the study in the next quarter. We have also received useful input from the MPA about the development path for Endoxifen. Based in part on that input we will consider conducting future studies to measure the treatment effect of Endoxifen not only on MBD reduction but also on the reduction of the incidence of breast cancer. In addition to clinical data, regulators will require that we also develop preclinical information including toxicology studies and information about manufacturing oral Endoxifen prior to regulatory approval. We have now established two manufacturing sources of Endoxifen for clinical and potential future commercial use and we have initiated a significant portion of the preclinical studies needed for a New Drug Application.”

The primary objective of the MBD study is to determine the dose-response relationship of daily oral Endoxifen on mammographic breast density reduction, with secondary endpoints assessing safety and tolerability. The Phase 2 study will be randomized, double-blinded and placebo-controlled. It will be conducted in Stockholm and will include approximately 240 pre-menopausal women with measurable MBD who will receive daily doses of oral Endoxifen or placebo for six months. South General Hospital in Stockholm will be conducting the study. The study is being led by principal investigator Per Hall, M.D., Ph.D., Head of the Department of Medical Epidemiology and Biostatistics at Karolinska Institutet. The study is also subject to approval by the institutional ethics committees and enrollment will not begin unless and until all approvals are obtained and COVID restrictions are lifted in Sweden.

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