MIAMI, June 06, 2025 (GLOBE NEWSWIRE) — RESTEM – a clinical-stage biotechnology company that develops off-the-shelf, next-generation cell therapies designed to modulate the immune system, today announced that it will present the rationale and study design of its Phase 2/3 IIMPACT (Idiopathic Inflammatory Myopathy Phase 2/3 Adaptive Clinical Trial) trial of Restem-L, the Company’s umbilical-lining modified progenitor cells (UMPC) program for the treatment of Polymyositis and Dermatomyositis (PM/DM), a rare autoimmune disease, now defined by the FDA as Idiopathic Inflammatory Myopathy (IIM). The oral presentation will be delivered at the European Alliance of Associations for Rheumatology’s (EULAR) 2025 Congress, to take place June 11-14 in Barcelona, Spain.
Details of the oral presentation are as follows:
Abstract Title: Rationale and Study Design for a Phase 2/3, Double-blinded, Randomized, Dose-repeating, Cross-over Study to Assess Safety and Efficacy of Allogeneic Umbilical Cord Lining Stem Cells on Disease Severity and Steroid Tapering in Participants with Idiopathic Inflammatory Myopathy
Abstract Number: OP0318
Session Title: Clinical Abstract Sessions: Novelties and innovative therapeutic strategies in inflammatory myopathies
Session Date and Time: Friday, June 13, 2025, 10:30 AM CEST
About Idiopathic Inflammatory Myopathy (IIM)
Idiopathic inflammatory myopathies (IIM) are a group of conditions characterized by inflammation of muscles (myositis) and other body systems. Polymyositis and dermatomyositis are subtypes of IIM. Polymyositis causes inflammation and weakness of the skeletal muscles responsible for movement. Dermatomyositis is a form of polymyositis that is associated with skin rash, in addition to muscle inflammation. Both disorders can significantly compromise the quality of life and are very challenging to treat. Currently, the only treatment for these disorders is immunosuppressive drugs, which can be associated with significant toxicity and other side effects.
About RESTEM
RESTEM is a leading clinical-stage biotechnology company focused on developing off-the-shelf, next-generation cell therapies designed to modulate the immune system. Leveraging our proprietary products, robust clinical development expertise, and cutting-edge-manufacturing capabilities, we are advancing two potentially groundbreaking programs, Restem-L, our umbilical-lining modified progenitor cells (UMPC) program for autoimmune diseases; and our activated natural killer cell (aNK) therapeutics targeting senescence and age-associated disorders. Our therapies are uniquely positioned to redefine the standard of care for patients with limited options, by suggesting an immune system remodeling—rather than mere symptom suppression—offering a potential path to true disease resolution. RESTEM is headquartered in Miami, Florida. For more information, please visit www.restem.com and follow us on X and LinkedIn.
Investor Contact
Daniel Ferry
LifeSci Advisors
+1.617.430.7576
daniel@lifesciadvisors.com
Media Contact
Nelson Cabautan
Restem Group, Inc.
+1.800.490.0924
ncabatuan@restem.com
