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Millendo Therapeutics Announces Data Presentations at AE-PCOS

Thursday, November 3, 2016   (0 Comments)
Posted by: Kate Oesterle
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Millendo Therapeutics Announces Data Presentations at Androgen Excess and Polycystic Ovary Syndrome Society Annual Meeting

-- Presentation to Include Comprehensive Clinical and Preclinical Summary of MLE4901 Compound for Polycystic Ovary Syndrome (PCOS) --


ANN ARBOR, Mich., Nov. 3, 2016 – Millendo Therapeutics, Inc., a clinical-stage biopharmaceutical company focused on developing novel treatments for endocrine diseases caused by hormone dysregulation, today announced that it will present data from its MLE4901 program during a special oral session at the Androgen Excess and Polycystic Ovary Syndrome (AE-PCOS) Society annual meeting, held from November 10-12, 2016 in Lorne, Australia.


“Polycystic Ovary Syndrome (PCOS) is a disease in which increased pulse frequency and levels of luteinizing hormone (LH) lead to downstream hormonal abnormalities including excess testosterone that result in the symptoms of PCOS,” said Pharis Mohideen, M.D., Chief Medical Officer of Millendo. “In our clinical and preclinical studies, we have observed that treatment with MLE4901 is associated with reduced testosterone levels, supporting further clinical development in patients with PCOS.”


“The data that will be presented at AE-PCOS support the ongoing clinical development of MLE4901 for the treatment of polycystic ovary syndrome, for which there are no approved treatment options,” said Julia C. Owens, Ph.D., President and Chief Executive Officer of Millendo. “We continue to advance MLE4901, in addition to ATR-101, as we progress our pipeline of novel potential therapies for patients with endocrine diseases.”


Dr. Mohideen and Andrew G. Spencer, Ph.D., Vice President of Preclinical Research and Development of Millendo, will give a podium presentation that will include clinical and preclinical data for MLE4901, which is currently being evaluated in a Phase 2b clinical trial in patients with PCOS. Details of the presentation are as follows:


Title: MLE4901, a novel neurokinin-3 receptor (NK3R) antagonist for the treatment of PCOS

Date: Saturday, November 12, 2016

Time: 9:50 a.m. – 10:20 a.m. AEDT

Location: Mantra Lorne Conference Center


In a Phase 2a study in women with PCOS, treatment with the neurokinin-3 receptor antagonist MLE4901 was associated with a reduction in luteinizing hormone (LH) pulse frequency and subsequent reductions in serum LH and free testosterone concentrations as well as LH:FSH ratio regardless of body mass index (BMI) levels. In a preclinical model, MLE4901 administration resulted in reduced levels of testosterone. These effects were confined to reproductive tissues and were sustained throughout a treatment course of 13 weeks, with pharmacodynamic response remaining intact at day 91 as demonstrated by decreased testosterone levels.


About MLE4901

MLE4901 is an antagonist of the Neurokinin 3 receptor (NK3R), which resides on the KNDy (kisspeptin/neurokinin B/dynorphin) neuron and acts to diminish GnRH hyperpulsatility, the central driver of PCOS. MLE4901 leverages recent biological insights that elucidated the critical role of the KNDy neuron as a regulator of reproductive hormonal signaling.


About Millendo Therapeutics, Inc.

Millendo Therapeutics is focused on developing novel treatments for endocrine diseases caused by hormone dysregulation. We are currently advancing two product candidates to treat four diseases. Based on our understanding of the novel biology underlying hormone dysregulation in endocrine diseases, we are developing our product candidates for conditions where current therapies are insufficient. Our clinical programs are designed to address:


·         Polycystic Ovary Syndrome (PCOS) – the most common endocrine disease in women

·         Congenital Adrenal Hyperplasia (CAH) – a recessive genetic defect of cortisol synthesis

·         Endogenous Cushing’s Syndrome (CS) – a condition resulting from chronic cortisol excess

·         Adrenocortical Carcinoma (ACC) – a rare endocrine malignancy of the adrenal cortex





Media Contact:

Casey Doucette

MacDougall Biomedical Communications

+1 781 235 3060

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