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Millendo To Stop Development Of Livoletide For Prader-Willi Syndrome

Millendo Therapeutics Inc. (MLND), a clinical-stage biopharmaceutical company developing novel treatments for orphan endocrine diseases, announced Monday that it is discontinuing the development of livoletide as a potential treatment for Prader-Willi syndrome or PWS.

Livoletide is an unacylated ghrelin analogue in late-stage clinical development for the treatment of hyperphagia in PWS.

The decision was based on topline data from the pivotal Phase 2b ZEPHYR study, which showed that treatment with livoletide did not result in a statistically significant improvement in hyperphagia and food-related behaviors as measured by the Hyperphagia Questionnaire for Clinical Trials or HQ-CT compared to placebo.

The ZEPHYR study was a two-part, randomized, double-blind, placebo-controlled pivotal Phase 2b/3 study.

The company noted that Livoletide was well tolerated during the ZEPHYR study, with injection site reaction being the most frequently reported adverse event, as expected with an injectable drug, and mostly mild in severity.

Millendo said it has made the decision to stop all livoletide development efforts in PWS, including the 9-month extension study and initiation of the Phase 3 ZEPHYR study.

Julia Owens, President and Chief Executive Officer of Millendo Therapeutics, said, "Moving forward, we will shift our development focus to compelling portfolio programs nevanimibe for congenital adrenal hyperplasia (CAH) and MLE-301 for menopausal vasomotor symptoms. With the rapidly evolving COVID-19 global pandemic and the extraordinary burden it has put on hospitals and healthcare providers, we are monitoring the potential impact of the situation on these programs and will provide an update when we have more clarity on expected timelines."

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