Based on accumulating data from the ongoing Phase 2 EVANGELINE study, the dose of (Z)-endoxifen in the combination study has been increased from 40 mg to 80 mg once daily. The change in study dose was determined following a review of safety, efficacy and pharmacokinetic (PK) data from participants currently enrolled in the 80 mg PK run-in cohort of the EVANGELINE study.
The EVANGELINE study is enrolling premenopausal women with ER+/HER2- breast cancer. The study began with a 40 mg pharmacokinetic (PK) run-in cohort. Data from this cohort, which was presented at the 2024
Additionally, the combination study will now enroll approximately 80 participants across two 40-participant cohorts. Both cohorts will include pre-and-menopausal women who will receive 80 mg (Z)-endoxifen once daily in combination with 150 mg abemaciclib twice daily for up to 24-weeks prior to surgery. Premenopausal women in the second cohort will also receive ovarian function suppression (OFS).
Increasing the number of study participants was done to ensure a statistically significant number of menopausal and premenopausal women are enrolled in each cohort. The addition of OFS in premenopausal women enrolled in the second cohort of the study will allow for a direct comparison of safety and efficacy among the two treatment groups. This data is expected to further validate the growing body of evidence that (Z)-endoxifen is safe and highly efficacious in premenopausal women without the need for OFS.
“We are extremely excited about the updated combination study protocol and grateful for the significantly expanded support from Eli Lilly to run the trial,” said
Under the terms of the study agreement, Atossa and Eli Lilly and Company are each responsible for supplying their respective study drugs.
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 four 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
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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, including the timing of data related to the (Z)-endoxifen program, the potential of (Z)-endoxifen as a breast cancer prevention and treatment agent, and the potential safety and tolerability profile of (Z)-endoxifen, 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 comply with the continued listing requirements of the
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