Livoletide, a potential first-in-class treatment for Prader-Willi syndrome (PWS), will be featured in two poster sessions. The company will provide an overview of the study design for the pivotal Phase 2b/3 ZEPHYR clinical trial to evaluate the safety and efficacy of livoletide for hyperphagia and related food-related behaviors in PWS patients in one poster session. Data from the livoletide nonclinical safety program to support its clinical development will be presented in another session. The company will also give an overview of its ongoing nevanimibe Phase 2b open-label study in patients with classic congenital adrenal hyperplasia (CAH) in a third session. Top-line results from the Phase 2b portion of ZEPHYR and the Phase 2b study for nevanimibe in CAH are expected in the first-half of 2020.
Details of the poster presentations are as follows:
Title: ZEPHYR, a Pivotal Phase 2b/3 Randomized,
Placebo-Controlled Study of Livoletide, a Novel Unacylated Ghrelin
Analog, for the Treatment of Hyperphagia and Food-Related Behaviors in
Patients with Prader-Willi Syndrome
Session: P05, Obesity Comorbidities and Therapies
Title: Multicenter, Dose-titration, Open-Label Phase 2b Study of
Nevanimibe Hydrochloride, a Novel ACAT1 Inhibitor, for the Treatment of
Classic Congenital Adrenal Hyperplasia
Session: P37, Adrenal Tumors and Hyperplasia
Session: P49, Treatment of Obesity in Unique Populations
Millendo’s lead asset, livoletide, is an unacylated ghrelin analogue in late-stage clinical development for the treatment of Prader-Willi syndrome (PWS), a rare genetic disease characterized by hyperphagia, a chronic unrelenting hunger, that leads to obesity, metabolic dysfunction, reduced quality of life and early mortality. In a randomized, double-blind, placebo-controlled Phase 2 clinical trial in 47 patients with PWS, administration of livoletide once daily was associated with a clinically meaningful improvement in hyperphagia, as well as a reduction in appetite. Millendo has received orphan drug designation for livoletide from the
Nevanimibe decreases adrenal steroidogenesis through the selective inhibition of ACAT1 and is being studied for the treatment of two orphan adrenal diseases: classic congenital adrenal hyperplasia (CAH) and endogenous Cushing’s syndrome (CS). CAH is a rare, monogenic adrenal disease that requires lifelong treatment with exogenous cortisol, often at high doses, which can make it difficult for physicians to appropriately treat CAH without causing adverse consequences. Millendo has received orphan drug designation for nevanimibe for the treatment of CAH and CS from the
Millendo Therapeutics is a late-stage biopharmaceutical company focused on developing novel treatments for orphan endocrine diseases where current therapies do not exist or are insufficient. As a leading orphan endocrine company, Millendo creates distinct and transformative treatments where there is a significant unmet medical need. The company is currently advancing livoletide for the treatment of Prader-Willi syndrome and nevanimibe for the treatment of classic congenital adrenal hyperplasia and endogenous Cushing’s syndrome. For more information, please visit www.millendo.com.
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