ANN ARBOR — A new drug to treat polycystic ovary syndrome got good results in a Phase 2a clinical trial, according to the drug’s developer, Millendo Therapeutics Inc. of Ann Arbor.
The results were published online in the Journal of Clinical Endocrinology and Metabolism.
Polycystic ovary syndrome, the most common endocrine disease in women, and is estimated to affect 8 to 20 percent of the female population. Symptoms include irregular or absent menstruation, infertility, diabetes, and, in some cases, acne and excess hair. There are no approved therapies on the market.
Millendo’s drug candidate, called MLE4901, was well-tolerated in the clinical trial and reduced testosterone and luteinizing hormone concentrations within seven days of treatment.
“The results of this study demonstrate the tremendous potential of MLE4901, a first-in-class, first-in-disease, non-hormonal therapy for the treatment of PCOS, for which there are currently no approved therapies,” said Julia C. Owens, Millendo president and CEO. “We are eager to continue the development of MLE4901 by initiating a Phase 2b clinical trial in patients with PCOS later this year.”
The trial (ClinicalTrials.gov identifier NCT01872078) was a randomized, double blind, placebo-controlled, multi-center, international study evaluating the safety and efficacy of three dose regimens of MLE4901 (20 mg once daily, 20 mg twice daily, and 40 mg twice daily) in 65 PCOS patients. The primary efficacy endpoint was the change from baseline of LH levels to Day 7 of treatment, and the endpoint was analyzed using mixed effects models for repeated measures. The results were reported on an intent-to-treat basis. The study was sponsored by AstraZeneca, who licensed the compound to Millendo in 2015.