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Nonhormonal PCOS drug enters phase 2b trial
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Millendo Therapeutics announced the initiation of a phase 2b clinical trial for a non-hormonal therapy, MLE4901, for the treatment of polycystic ovary syndrome, according to a press release.
MLE4901 is a neurokinin 3 receptor antagonist that acts to diminish the gonadotropin-releasing hormone hyperpulsatility associated with PCOS.
The trial will be a double blind, randomized, parallel-group, placebo-controlled study to evaluate the efficacy of MLE4901. The trial includes patients with PCOS and will continue over a 7-month dosing period. Researchers will be assessing for improved menstrual regularity.
“We believe our lead candidate, MLE4901, addresses a significant unmet medical need, offering a new therapeutic option for PCOS beyond current off-label therapies, which are limited to managing patient symptoms,” Julia C. Owens, PhD, president and chief executive officer of Millendo, said in the release. “The initiation of this phase 2b clinical trial marks the continued advancement of MLE4901 and is an important milestone in the progression of our robust clinical portfolio of novel treatment options for endocrine diseases.”
The trial will be conducted in the U.S. and UK.