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

Rhea-AI Summary

Atossa Therapeutics, Inc. (Nasdaq: ATOS) has received approval from the Swedish Medical Product Agency to launch a Phase 2 clinical trial of its oral Endoxifen aimed at reducing mammographic breast density (MBD), a significant public health concern affecting millions of women. The study will involve about 240 pre-menopausal women and aims to assess the dose-response relationship of Endoxifen over six months. The company plans to initiate the trial once COVID-19 restrictions in Stockholm are lifted, with potential for broader future studies to evaluate Endoxifen's impact on breast cancer incidence.

Positive

• Approval received for Phase 2 study of oral Endoxifen.
• Study aims to address MBD, impacting over 10 million women in the U.S.
• Clinical trial includes approximately 240 participants, allowing for robust data collection.
• Two manufacturing sources for Endoxifen established for clinical and potential commercial use.

Negative

• Study initiation is dependent on lifting COVID-19 restrictions, causing potential delays.
• Regulatory hurdles and the requirement for preclinical toxicology studies may extend the timeline for a New Drug Application.

SEATTLE, June 11, 2021 (GLOBE NEWSWIRE) -- 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.

About Atossa Therapeutics

Atossa Therapeutics, Inc. is a clinical-stage biopharmaceutical company seeking to discover and develop innovative medicines in oncology and infectious diseases with a current focus on breast cancer and COVID-19. For more information, please visit www.atossatherapeutics.com.

Forward-Looking Statements

Forward-looking statements in this press release, which Atossa undertakes no obligation to update, are subject to risks and uncertainties that may cause actual results to differ materially from the anticipated or estimated future results, including the risks and uncertainties associated with any variation between interim and final clinical results, actions and inactions by the FDA, the outcome or timing of regulatory approvals needed by Atossa including those needed to commence studies of AT-H201, AT-301 and Endoxifen, lower than anticipated rate of patient enrollment, estimated market size of drugs under development, the safety and efficacy of Atossa’s products, performance of clinical research organizations and investigators, obstacles resulting from proprietary rights held by others such as patent rights, whether reduction in Ki-67 or any other result from a neoadjuvant study is an approvable endpoint for oral Endoxifen, and other risks detailed from time to time in Atossa’s filings with the Securities and Exchange Commission, including without limitation its periodic reports on Form 10-K and 10-Q, each as amended and supplemented from time to time.

Company Contact:
Atossa Therapeutics, Inc.
Kyle Guse CFO and General Counsel
Office: (866) 893-4927
kyle.guse@atossainc.com 

Investor Relations Contact:
Core IR
Office: (516) 222-2560
ir@atossainc.com 

Source: Atossa Therapeutics, Inc.

FAQ

What is the purpose of Atossa's Phase 2 clinical study of Endoxifen?

The study aims to evaluate the effectiveness of oral Endoxifen in reducing mammographic breast density, which is linked to increased breast cancer risk.

When is Atossa expected to start the Phase 2 clinical trial?

Atossa plans to commence the trial as soon as COVID-19 restrictions in Stockholm are lifted, potentially within the next quarter.

How many participants will be involved in the Endoxifen study?

The study will include approximately 240 pre-menopausal women with measurable mammographic breast density.

What are the secondary endpoints of the clinical trial?

In addition to the primary objective, the trial will also assess the safety and tolerability of oral Endoxifen.

What regulatory approvals does Atossa need for the Endoxifen study?

The trial is subject to approval by institutional ethics committees, and all necessary regulatory approvals must be obtained before enrollment begins.