Benzinga | Sep 2, 2021 09:31AM EDT

Atossa Therapeutics Reports Approval From Swedish Ethics Review Authority To Initiate Phase 2 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 areas of significant unmet medical need in oncology and infectious diseases with a current focus on breast cancer and COVID-19, today announced it has received approval from the Swedish Ethics Review Authority to begin a Phase 2 clinical study of 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 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.

"With this ethics approval and the previously reported regulatory approval to conduct the clinical study, we plan to start enrolling participants in fourth quarter 2021," said Steven Quay, M.D., Ph.D., Atossa's Chairman and CEO. "We are excited to be working with Dr. Per Hall, a world leader in the field of breast density reduction, once again with our Endoxifen program."

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 increased breast density. The primary objective of the study is to determine the dose-response relationship of daily oral Endoxifen on MBD reduction, with secondary endpoints to assess safety, and tolerability, and an exploratory endpoint to assess durability of the MBD changes. It will be conducted in Stockholm and will include approximately 240 participants 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.