Millendo Launches Phase 2b Study of PCOS Drug After Year of Growth

Millendo Therapeutics, the Ann Arbor, MI-based biotech company developing drugs to treat endocrine diseases, last month began Phase 2b clinical trials for MLE4901, a non-hormonal therapy for the treatment of polycystic ovary syndrome (PCOS). There currently aren’t any approved therapies for PCOS, which is the most common endocrine disease in women.

Julia Owens, president and CEO of Millendo, says the company believes MLE4901 meets a significant unmet medical need and offers hope to patients currently managing PCOS symptoms through off-label therapies.

“We had some very nice data in the Phase 2a study,” Owens explains, noting the findings were published online this summer in the Journal of Clinical Endocrinology and Metabolism. “Phase 2b is a larger study to really translate biochemical changes that establish proof of mechanism, and establish scope and efficacy. It’s really important for us—we’re ahead of schedule and there’s a lot of enthusiasm.”

The Phase 2b study will assess, over seven months of dosing, the impact of MLE4901 in improving menstrual regularity in women with amenorrhea or oligomenorrhea resulting from PCOS. The multicenter, international trial will be conducted at up to 35 sites in the U.S. and U.K.

Owens says it’s hard to predict how long the 2b study will take to complete, but Millendo will spend about a year enrolling patients. The company may work with a pharma partner at some point in MLE4901’s development process, Owens says, but the plan is for Millendo to take the drug to market on its own.

“Endocrine diseases don’t require huge studies,” she adds. “We may consider a marketing partner in the future, but we don’t have to do it. Millendo can execute Phase 3 [on its own], as well.”

Millendo is perhaps uniquely qualified to make such an attempt. Owens says five people on the Millendo team previously worked at QuatRx Pharmaceuticals developing drugs for women’s health. Thanks to the $62 million Series B round Millendo closed late last year, Owens says the company is currently in a good financial position to complete the clinical study of MLE4901.

“It’s the same regulatory strategy, and we have direct experience developing drugs in this space,” she says.

Formerly known as Atterocor before changing its name last year, Millendo is also developing ATR-101, a novel drug candidate to treat adrenal cancer. Owens says a Phase 2 study of the compound, launched in June, is “moving forward nicely.”

Millendo has made some key hires recently to help manage its pipeline of drugs under development. In April, the company named Thomas Hoover its vice president of commercial strategy and Andrew Spencer its vice president of preclinical research and development.

“It’s great to build out our team, which has more than doubled,” Owens says. “We’ve had a phenomenal year, with financial resources to have multiple shots on goal. We’re really proud of what we’ve been able to accomplish in the past nine months.”

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