• JUV-161 is a first-in-class muscle regenerating biologic that will address myopathies starting with Myotonic Dystrophy Type 1
• JUV-161 was discovered using Juvena’s proprietary JuvNET platform, an AI and stem cell secretome-based drug discovery and development platform

Juvena Therapeutics, Inc. (“Juvena”), a clinical-stage biotechnology company pioneering tissue restorative biologics for chronic muscle and metabolic diseases, announced today that it is enrolling participants into its clinical trial evaluating JUV-161, a first-in-class fusion protein that enhances muscle regeneration through its pro-myogenic, insulin-resistance modulating, and anti-inflammatory properties. JUV-161 is a muscle regenerating endocrine therapy being investigated for the treatment of Myotonic Dystrophy Type 1 (DM1) and Sarcopenia. JUV-161 received FDA Orphan Disease Drug designation for DM1 in 2024.

“JUV-161 is a natural, endocrine protein therapy that will help restore critical protein signaling in diseased muscle to more youthful, healthy levels, so that we can restore muscle health and ultimately restore the quality of life of individuals living with many indications where muscle loss reduces the quality of life or lifespan,” said CEO and co-founder of Juvena Therapeutics, Dr. Hanadie Yousef. “JUV-161 is a unique tissue restorative therapy that is different from other anti-sense, RNA-targeting, or gene therapy knockdown approaches currently being taken for DM1.”

“As the world’s largest myotonic dystrophy patient advocacy organization, founded by families impacted by DM and supporting research toward treatments and cures, the Myotonic Dystrophy Foundation is super excited about Juvena Therapeutics’ lead candidate, JUV-161, entering the clinical testing phase with a truly novel approach,” said Myotonic Dystrophy Foundation, Chief Science Officer, Dr. Andy Rohrwasser. “This milestone is great news for myotonic dystrophy (DM) families because JUV-161 targets muscle regeneration and metabolism to improve overall muscle function and health and has the potential to improve and restore muscle.”

“With JUV-161, we’re thrilled to bring to the clinic the first asset emerging from our JuvNET platform which deconvolutes human stem cell secretome biology with a combination of quantitative proteomics and AI,” said Dr. Jeremy O’Connell, Chief Scientific Officer and co-founder of Juvena Therapeutics. “As we continue to unlock the therapeutic potential of a proven yet understudied source of biologics, Juvena is poised to identify life-changing muscle regenerative and pro-metabolic therapies in high demand across disease categories.”