Atossa Therapeutics Announces Last Patient, Last Dose in its Phase 2 Karisma-Endoxifen Clinical Trial
Atossa Therapeutics announced the completion of patient dosing in its Phase 2 Karisma-Endoxifen clinical trial. This study, which enrolled 240 premenopausal women with mammographic breast density (MBD), aims to reduce MBD, a risk factor for breast cancer. The trial, fully enrolled in November 2023, tested daily doses of 1 mg and 2 mg (Z)-endoxifen versus placebo over six months. Results will be important for potential Phase 3 trials. MBD reduction is linked to a 50%-63% decrease in breast cancer risk over 3-15 years. Atossa is focusing on breast cancer treatments, with five ongoing Phase 2 studies.
- Completion of patient dosing in the Phase 2 Karisma-Endoxifen trial.
- Trial enrolled 240 premenopausal women, indicating strong study participation.
- Focus on reducing mammographic breast density, linked to significantly lower breast cancer risk.
- Potential for Phase 3, registrational study if results are positive.
- Atossa's focus on innovative breast cancer therapies addressing unmet medical needs.
- Results of reduction in mammographic breast density are pending, creating uncertainty.
- High risk of inaccurate mammograms due to dense breast tissue, affecting trial outcomes.
- 50% of breast cancers in dense breast tissue can be missed, challenging efficacy evaluations.
Insights
The completion of patient dosing in Atossa Therapeutics' Phase 2 Karisma-Endoxifen clinical trial is a significant milestone in the field of oncology. Mammographic breast density (MBD) is a major risk factor for breast cancer and reducing it can potentially decrease cancer incidence by up to 63% in the long run. The information that this study targets premenopausal women, who often have denser breast tissue, is particularly critical. If (Z)-endoxifen proves effective in reducing MBD, it could fill a significant unmet need in breast cancer prevention and treatment. This trial's outcome might pave the way for a larger, Phase 3 study, bringing the drug closer to market approval.
Additionally, the potential for reducing interval cancers, which are often more advanced, could have profound implications on patient outcomes. The oncology community will be keenly watching the forthcoming data, as positive results could shift current prevention strategies significantly. However, it’s important to note that the real impact will be gauged once efficacy and safety data are thoroughly analyzed and compared to existing treatments.
From a market perspective, the Phase 2 trial's completion is a important step for Atossa Therapeutics. It signals progression towards commercialization, potentially opening a large market if (Z)-endoxifen is successful. Breast cancer is one of the most common cancers worldwide and about half of all women have high mammographic breast density, a difficult and underserved market segment. The ability to reduce this density and lower cancer risk addresses a massive patient population, which could translate into substantial market adoption.
Additionally, the company's focus on breast cancer, an area with significant annual spending, positions it well for strategic partnerships, investments and acquisition opportunities. Investors should keep an eye on regulatory feedback and subsequent study phases, as these will be critical in assessing the commercial viability. Short-term market reactions might be positive due to the milestone, but long-term success hinges on subsequent trial results and regulatory pathways.
SEATTLE, May 15, 2024 (GLOBE NEWSWIRE) -- Atossa Therapeutics, Inc. (Nasdaq: ATOS) (“Atossa” or the “Company”) today announced that the last patient in the Company’s Karisma-Endoxifen clinical trial received their final dose of study medication. Atossa is a clinical stage biopharmaceutical company developing innovative medicines in areas of significant unmet medical need in oncology with a focus on breast cancer.
The Karisma-Endoxifen study, which fully enrolled in November 2023, is a 240-person Phase 2 clinical trial investigating (Z)-endoxifen in premenopausal women with measurable mammographic breast density (MBD). Participants were randomized to placebo, 1 mg, and 2 mg daily doses of (Z)-endoxifen and treated for six months, over the course of which mammograms are conducted to measure reduction in MBD. Medication-induced MBD reduction has been associated with a
Approximately half of all women are estimated to have mammographically dense breasts, which makes mammography less sensitive and mammograms more difficult to interpret, since cancer and dense breast tissue both appear white on a mammogram. Women with the highest density are up to six-times more likely to develop breast cancer in their lifetime compared to women with the lowest density. Additionally, in this patient population, approximately
“Completing dosing of the final patient in the Karisma-Endoxifen study is an important milestone for Atossa and our robust (Z)-endoxifen development program, which includes five ongoing Phase 2 studies,” said Steven Quay, M.D., Ph.D., Atossa’s President and Chief Executive Officer. “We look forward to seeing the breast density reduction data in the coming months and sharing it with regulatory authorities as it will allow us to further progress plans for a potential Phase 3, registrational study.”
About (Z)-Endoxifen
(Z)-endoxifen is the most potent Selective Estrogen Receptor Modulator (SERM) for estrogen receptor inhibition and also causes estrogen receptor degradation. It has also been shown to have efficacy in the setting of patients with tumor resistance to other hormonal treatments. In addition to its potent anti-estrogen effects, (Z)-endoxifen has been shown to target PKCβ1, a known oncogenic protein, at clinically attainable blood concentrations. Finally, (Z)-endoxifen appears to deliver similar or even greater bone agonistic effects while resulting in little or no endometrial proliferative effects compared with standard treatments, like tamoxifen.
Atossa is developing a proprietary oral formulation of (Z)-endoxifen that does not require liver metabolism to achieve therapeutic concentrations and is encapsulated to bypass the stomach, as acidic conditions in the stomach convert a significant proportion of (Z)-endoxifen to the inactive (E)-endoxifen. Atossa’s (Z)-endoxifen has been shown to be well tolerated in Phase 1 studies and in a small Phase 2 study of women with breast cancer. (Z)-endoxifen is currently being studied in five Phase 2 trials: one in healthy women with measurable breast density, one in women diagnosed with ductal carcinoma in situ, and two other studies including the EVANGELINE study in women with ER+/HER2- breast cancer. Atossa’s (Z)-endoxifen is protected by three issued U.S. patents and numerous pending patent applications.
About Atossa Therapeutics
Atossa Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing innovative medicines in areas of significant unmet medical need in oncology with a focus on using (Z)-endoxifen to prevent and treat breast cancer. For more information, please visit www.atossatherapeutics.com.
Contact
Eric Van Zanten
VP, Investor and Public Relations
610-529-6219
eric.vanzanten@atossainc.com
FORWARD LOOKING STATEMENTS
This press release contains certain information that may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. We may identify these forward-looking statements by the use of words such as “expect,” “potential,” “continue,” “may,” “will,” “should,” “could,” “would,” “seek,” “intend,” “plan,” “estimate,” “anticipate,” “believe,” “future,” or other comparable words. Forward-looking statements in this press release are subject to risks and uncertainties that may cause actual results, outcomes, or the timing of actual results or outcomes, such as data related to the (Z)-endoxifen program and the potential of (Z)-endoxifen as a breast cancer prevention and treatment agent, to differ materially from those projected or anticipated, including risks and uncertainties associated with: macroeconomic conditions and increasing geopolitical instability; the expected timing of releasing data; any variation between interim and final clinical results; actions and inactions by the FDA and foreign regulatory bodies; the outcome or timing of regulatory approvals needed by Atossa, including those needed to continue our planned (Z)-endoxifen trials; our ability to satisfy regulatory requirements; our ability to remain compliant with the continued listing requirements of the Nasdaq Stock Market; our ability to successfully develop and commercialize new therapeutics; the success, costs and timing of our development activities, including our ability to successfully initiate or complete our clinical trials, including our (Z)-endoxifen trials; our anticipated rate of patient enrollment; our ability to contract with third-parties and their ability to perform adequately; our estimates on the size and characteristics of our potential markets; our ability to successfully defend litigation and other similar complaints and to establish and maintain intellectual property rights covering our products; whether we can successfully complete our clinical trial of oral (Z)-endoxifen in women with mammographic breast density and our trials of (Z)-endoxifen in women with breast cancer, and whether the studies will meet their objectives; our expectations as to future financial performance, expense levels and capital sources, including our ability to raise capital; our ability to attract and retain key personnel; our anticipated working capital needs and expectations around the sufficiency of our cash reserves; and other risks and uncertainties detailed from time to time in Atossa’s filings with the Securities and Exchange Commission, including without limitation its Annual Reports on Form 10-K and Quarterly Reports on 10-Q. Forward-looking statements are presented as of the date of this press release. Except as required by law, we do not intend to update any forward-looking statements, whether as a result of new information, future events or circumstances or otherwise.
FAQ
What is the significance of Atossa's completion of the Karisma-Endoxifen trial?
What is the focus of the Karisma-Endoxifen clinical trial?
When was the Karisma-Endoxifen trial fully enrolled?
What are the dosages tested in the Karisma-Endoxifen trial?
What is the relationship between mammographic breast density and breast cancer risk?
