ANN ARBOR — The pharma startup Millendo Therapeutics Inc. announced the start of a Phase 2b clinical trial to assess the efficacy of drug candidate MLE4901, a non-hormonal therapy for the treatment of polycystic ovary syndrome.
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, Millendo president and CEO. “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 aim is to assess the impact of MLE4901 in improving menstrual regularity in women with missing or infrequent menstruation resulting from PCOS. The multicenter, international study will be conducted at sites in the United States and the United Kingdom. For additional information on this clinical trial, please visit clinicaltrials.gov, trial identifier NCT02865915.
Millendo 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 concentrations at Day 7 of treatment. The results were published online in the Journal of Clinical Endocrinology and Metabolism.
PCOS is estimated to affect between 8 and 20 percent of the female population. PCOS is caused by Gonadotropin Releasing Hormone hyperpulsatility, which leads to increased luteinizing hormone pulse frequency and downstream hormonal abnormalities including androgen excess. Clinical symptoms include menstrual dysfunction, androgen excess — which can include acne, weight gain, excessive hair growth and infertility — and metabolic syndrome, a pre-diabetic condition. Current treatments are used off-label and are directed at managing symptoms.
Millendo is developing disease-modifying treatments for endocrine diseases caused by hormone dysregulation. In addition to PCOS, the company’s clinical research is designed to treat Congenital Adrenal Hyperplasia (CAH), a recessive genetic defect of cortisol synthesis; Endogenous Cushing’s Syndrome (CS), a condition resulting from chronic cortisol excess; and Adrenocortical Carcinoma (ACC), a rare endocrine malignancy of the adrenal cortex.
More at www.millendo.com.