Juvena Therapeutics Announces Initiation of First-in-Human Clinical Trial of JUV-161REDWOOD CITY, Calif., May 19, 2025 (GLOBE NEWSWIRE) -- 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.
Juvena Therapeutics Receives FDA Orphan Drug Designation for JUV-161 for the Treatment of Myotonic Dystrophy Type 1
Juvena Therapeutics, a biotechnology company unlocking the potential of stem cell-secreted proteins to treat muscle and metabolic diseases including muscular dystrophies and obesity, today announced the U.S. Food and Drug Administration (FDA) granted Orphan Drug designation to the company’s flagship candidate, JUV-161. JUV-161 is an investigational therapeutic for the treatment of Myotonic Dystrophy Type 1 (DM1), a rare, multi-systemic, autosomal dominant inherited disease and the most common form of adult muscular dystrophy.
