Plus   Neg

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."

For comments and feedback contact: editorial@rttnews.com

Business News

Editors Pick
NASA's Osiris-Rex robotic spacecraft briefly touched down on near-Earth asteroid Bennu's surface on Tuesday to collect rock and dust samples that will be brought back to Earth in 2023. Bennu is currently more than 200 million miles, or 321 million kilometres, from Earth. Osiris-Rex launched from Cape Canaveral Air Force Station in Florida in September 2016. Amazon said Wednesday that free one-hour grocery pickup is now available to prime members at all U.S. Whole Foods Market locations. Previously, the prime members could pick up Whole Foods orders only at select stores. J.C. Penney said it is near to exiting Chapter 11 ahead of the busy December 2020 holiday season. The beleaguered retailer filed a draft asset purchase agreement towards finalization of the acquisition by Brookfield Asset Management, Inc. and Simon Property Group, Inc. They are expected to buy substantially all of J.C. Penney's retail and operating assets in a combination of cash and debt.
Follow RTT