Millendo drops another drug candidate

ANN ARBOR—Millendo Therapeutics Inc. (Nasdaq: MLND), a pharmaceutical startup developing new drugs for endocrine diseases, announced that it had engaged SVB Leerink, a Boston-based investment bank, in a “strategic review process” to determine the company’s future direction, after dropping another drug candidate.

In April, the company dropped development of a new drug to treat a rare metabolic condition, Prader-Willi Syndrome, that causes unrelenting hunger—and therefore obesity. The drug wasn’t effective in early trials. After that, the company’s stock plunged 70 percent.

The latest drug, nevanimibe, has also been dropped after only one of 10 patients in a study met intended end points for treatment for congenital adrenal hyperplasia, a rare adrenal disease that requires lifelong treatment with cortisol, often at high doses. These chronic high doses of cortisol can result in side effects that include diabetes, obesity, hypertension and psychological problems.

The company continues to develop MLE-301, a drug being developed to treat hot flashes and night sweats in menopausal women. An Investigational New Drug application has been filed for it with the U.S. Food and Drug Administration. The menopausal symptoms, medically known as vasomotor symptoms, affect 70 percent of perimenopausal and post-menopausal women, more than 20 million in the U.S. alone. Phase 1 clinical studies are expected to begin by Sept. 30.

“Our board of directors and leadership team recognize the importance of conducting a comprehensive and strategic review. We are aligned in our focus on evaluating our pipeline and its potential, beginning with the advancement of MLE-301,” said Julia C. Owens, Millendo president and CEO. “Our objective is to come away from this process with an actionable plan that leverages our assets, capital and capabilities in a way that maximizes shareholder value.”

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