Atossa Therapeutics estimates a Q3 readout of a Phase II trial that studies the company’s lead asset z-endoxifen, says CEO Dr. Steven Quay, in an interview with Pharmaceutical Technology.

In November, the US-based biotech announced that it had completed enrollment for its Karisma endoxifen Phase II trial (NCT05068388). Atossa is conducting the study at the South General Hospital in Stockholm, recruiting 240 pre-menopausal women with measurable MBD. Quay said that the company estimates a Phase II data readout for the trial in Q3 2024. The Karisma study is investigatings Z-endoxifen as a preventative treatment for breast cancer.

Quay says the typical primary endpoint for preventative therapies for cancer looks at the number of patients who pass away during the course of the study. He says this is a difficult endpoint to demonstrate significant efficacy. Furthermore, he highlights the uncertainty surrounding the ideal trial length for preventative studies and choosing the necessary endpoints. The company plans to discuss Phase III plans with the FDA to devise an appropriate trial design.

Atossa is also investigating the drug in the I-Spy 2 trial (NCT01042379) and the EVANGELINE trial (NCT05607004) for the treatment of ER+ invasive breast cancer in pre-and postmenopausal women and grade 1 or 2 ER+/HER2 breast cancer in premenopausal women respectively. Z-endoxifen acts by binding to oestrogen receptors, causing a blockage of the oestrogen-dependent gene. The therapy has a patented oral enteric capsule formulation that stabilises it upon oral administration.

In 2024, the company plans to present data from its ongoing trials at multiple conferences, says Quay. This includes the American Association for Cancer Research (AACR) annual meeting in April, and the American Society of Clinical Oncology (ASCO) annual meeting in June, says Quay.

In a 9 January letter to investors, Quay declared that the company had “a strong balance sheet with no debt and cash, cash equivalents and restricted cash of $94 million as of September 30, 2023.” The company also ran a share repurchase program, purchasing 1.32 million shares of stock at a cost $1.47 million in 2023. Atossa has extended this share repurchase program through to 31 December 2024. The program permits the purchase of up to $10 million of Atossa’s common stock, including purchases made in 2023. 

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Quay says the company is also open to partnerships to potentially test its drug in a combination therapy setting. He says that once Phase II data has released, the company may leverage it to begin partnership discussions.

Correction: The third paragraph was updated to accurately reflect Quay’s comments on the regulatory process for approving preventative therapies. The second and sixth paragraphs have been updated to indicate the correct status of the Karisma endoxifen trial and Atossa’s share repurchasing program.