The initiation of a Phase 2b clinical trial evaluating the efficacy of novel oral drug candidate MLE4901, a first-in-class, non-hormonal therapy for the treatment of polycystic ovary syndrome (PCOS) was announced by Millendo Therapeutics, Inc. on August 17. There are currently no approved therapies for PCOS, which is the most common endocrine disease in women.
“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,” said Julia C. Owens, PhD, president and CEO of Millendo, in a statement. “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 Phase 2b clinical trial is a double-blind, randomized, parallel-group, placebo-controlled study designed to evaluate the efficacy of MLE4901 in patients with PCOS over a seven-month dosing period. The primary endpoint will assess the impact of MLE4901 in improving menstrual regularity in women with amenorrhea or oligomenorrhea resulting from PCOS. The multicenter, international study will be conducted at sites in the U.S. and U.K. For additional information on this clinical trial, please visit clinicaltrials.gov, trial identifier NCT02865915.
The company recently announced the publication of results from an earlier Phase 2a clinical trial of MLE4901 in patients with PCOS, which met its primary endpoint of a change from baseline in serum luteinizing hormone (LH) concentrations at Day 7 of treatment. The results were published online in The Journal of Clinical Endocrinology & Metabolism.
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