Millendo Therapeutics Completes Patient Recruitment for Pivotal Study of Livoletide in Prader-Willi Syndrome
ANN ARBOR, Mich.--(BUSINESS WIRE)--Millendo Therapeutics, Inc. (Nasdaq: MLND), a clinical-stage biopharmaceutical company developing novel treatments primarily for orphan endocrine diseases, today announced that the Phase 2b portion of its pivotal Phase 2b/3 clinical study of livoletide in patients with Prader-Willi syndrome (PWS), called ZEPHYR, has completed recruitment for patients ages 8 to 65. The study, one of the largest PWS studies ever conducted with over 150 patients recruited across 38 clinical trial sites worldwide, is evaluating the safety and efficacy of livoletide on food-related behaviors in patients with PWS. The primary endpoint of the study is an assessment of livoletide’s impact on hyperphagia, the constant feeling of excessive hunger that is a hallmark symptom of the disease. Topline results are expected in the first half of 2020 and may support a New Drug Application (NDA) filing for livoletide.