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Atossa Therapeutics Streamlines EVANGELINE Clinical Trial

Atossa Therapeutics, Inc. (Nasdaq: ATOS), a biopharmaceutical company focused on innovative solutions in breast cancer treatment and prevention, has announced significant revisions to its Phase 2 clinical trial for (Z)-endoxifen, known as the EVANGELINE trial. This strategic amendment aims to enhance efficiency, reduce costs, and direct resources towards preparations for a New Drug Application (NDA) targeted for 2026.

The EVANGELINE study is specifically designed for premenopausal women diagnosed with early-stage ER+/HER2- breast cancer. The recent adjustments to the trial’s design are expected to lead to faster and more objective readouts, which in turn will streamline decision-making processes throughout the trial. These changes reflect Atossa's ongoing commitment to effective capital allocation, ensuring that resources are utilized where they will have the most significant impact.

Key Amendments and Their Implications

According to Atossa’s CEO Steven Quay, M.D., Ph.D., the decision to amend the study underscores a commitment to financial discipline while maintaining rigorous safety protocols. The streamlined trial is anticipated to cut future costs significantly and focus more sharply on key NDA-enabling activities as part of the company’s strategic vision through 2026.

Capital Allocation Highlights

• - Focused Objectives: The revised trial design is structured to minimize study costs and enhance focus on essential activities required for NDA submission.
• - Faster Decision Points: The trial has implemented a two-stage futility rule, particularly for patients in Cohort A who exhibit higher initial Ki-67 levels. This adjustment allows for more rapid, data-driven decisions during the study.
• - Safety Precautions Maintained: Importantly, the amendment does not alter the framework for patient safety or the oversight conducted by the Data Safety Monitoring Committee (DSMC).
• - Operational Efficiency: The study will transition to a single-arm, open-label structure that allows the team to concentrate on the most relevant regimen and data necessary for a future NDA.

Design Snapshot

The EVANGELINE trial, now amended, will feature the following key components:

• - Study Type: Non-registrational Phase 2 study targeting premenopausal women with ER+/HER2- breast cancer in a pre-surgical context.
• - Cohorts:

- Cohort A: Focus on initial Ki-67 > 10% with a strategy to assess early objectives.
- Cohort B: Patients with initial Ki-67 < 10% will pursue objective response assessments at a 24-week mark.

• - Study Size: The total number of participants will be reduced from 214 to between 40 and 65, allowing for a more focused approach.

Clinical Significance

The decision to streamline the EVANGELINE study follows initial data that indicated an impressive Week-4 Ki-67 ≤10% rate of 86% across evaluated (Z)-endoxifen doses, with and without ovarian function suppression (OFS). In comparison, reported response rates in similar settings show stark contrasts; for instance, a 41% response rate with tamoxifen, and a 78% with an aromatase inhibitor in combination with OFS. However, it is crucial to note that definitive efficacy conclusions cannot be established at this time due to the nature of ongoing studies.

About Atossa Therapeutics and (Z)-endoxifen

Atossa Therapeutics is dedicated to addressing considerable unmet needs in breast cancer through innovation. The investigational compound (Z)-endoxifen is a metabolite of tamoxifen, and while its potential efficacy in hormone receptor-positive breast cancers is being explored, its safety profile has yet to be fully established.

For continuous updates regarding trial activities, potential clinical sites like the Mayo Clinic and Dana-Farber Cancer Institute are involved in this essential study. As Atossa marches towards NDA-enabling work in 2026, the commitment to maximizing data integrity and patient safety remains paramount.

For further details, visit Atossa Therapeutics or check the ongoing clinical trial updates on ClinicalTrials.gov (NCT05607004).

Conclusion

The amendments to the EVANGELINE trial represent an important step in Atossa Therapeutics' journey towards addressing breast cancer with (Z)-endoxifen. By optimizing study parameters, Atossa is strategically positioning itself for efficient regulatory transitions, paving the way for potential future breakthroughs in breast cancer solutions.