Benzinga | Dec 22, 2021 09:31AM EST

Atossa Genetics Reports Begins Enrollment Of Phase 2 Study Of Oral Endoxifen In Sweden

Atossa Therapeutics, Inc. (NASDAQ:ATOS), a clinical stage biopharmaceutical company seeking to develop innovative medicines in areas of significant unmet medical need in oncology and infectious diseases with a current focus on breast cancer and COVID-19, today announces that it has initiated enrollment of its Phase 2 clinical study of oral Z-Endoxifen in Sweden. Participants in the study will be premenopausal women with elevated mammographic breast density, which is an emerging public health issue affecting more than 10 million women in the United States and many more worldwide.

"This is an extremely important milestone as it marks the next phase of developing our proprietary Z-Endoxifen," said Steven Quay, M.D., Ph.D., Atossa's Chairman and CEO. "This study will help determine the relationship between daily doses of Endoxifen and reduction in breast density and will help us further assess safety and tolerability. We look forward to providing progress updates as they become available."

The study, known as the Karisma-Endoxifen study, is a Phase 2, randomized, double-blind, placebo-controlled, dose-response study of Atossa's proprietary oral Z-Endoxifen in healthy premenopausal women with measurable breast density. The primary objective of the study is to determine the dose-response relationship of daily oral Z-Endoxifen on breast density reduction. Secondary endpoints will assess safety and tolerability, and the trial includes an exploratory endpoint to assess durability of the breast density changes. It will be conducted at the South General Hospital in Stockholm, and will include approximately 240 participants who will receive daily doses of oral Z-Endoxifen or placebo for six months. 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.