US-based Millendo Therapeutics has begun the Phase IIb clinical trial of MLE4901 to treat polycystic ovary syndrome (PCOS).

Millendo’s oral drug candidate, MLE4901, is a non-hormonal therapy and an antagonist of the Neurokinin 3 receptor (NK3R), which can be found on the (kisspeptin / neurokinin B / dynorphin) neuron that decreases Gonadotropin Releasing Hormone (GnRH) hyperpulsatility responsible for PCOS.

The double-blind, randomised, parallel-group, placebo-controlled Phase IIb trial is designed to test the efficacy of MLE4901 to treat PCOS.

It is expected to involve 220 females who will be administered with MLE4901 in three dosages against placebo for seven months.

"We believe our lead candidate, MLE4901, addresses a significant unmet medical need, offering a new therapeutic option for PCOS beyond current off-label therapies."

The trial is primarily focused on determining the effect of MLE4901 on improving menstrual regularity in women with PCOS-induced symptoms known as amenorrhea or oligomenorrhea.

The trial's secondary goal is to examine the number of menstrual periods during week 28 of a double blind treatment period.

Millendo president and CEO Julia Owens said: “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.

“The initiation of this Phase IIb 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.”

Millendo has recently reported positive Phase IIa clinical trial results of MLE4901 in treating PCOS, thereby achieving its primary goal of baseline change in serum luteinising hormone (LH) concentrations after seven days of treatment.