IRVINE, Calif.– Immunis, Inc., a clinical-stage biotech developing multi-active biologics for age and disease-related immune dysregulation, announces that it has initiated treatment in several patients of its STEM-META Phase 2 clinical trial. The Phase 2 trial will assess the safety and tolerability of Immunis’ investigational therapy, IMM01-STEM, in older patients with sarcopenia (muscle atrophy) related to obesity. The data from this trial will build upon the company’s Phase 1/2a trial investigating IMM01-STEM in adults with sarcopenia associated with knee osteoarthritis.
Aging heralds a progressive decline in immune system function, resulting in a cascade of degenerative conditions, including sarcopenia. Sarcopenia will occur in 100% of individuals as they age, yet there is no pharmaceutical treatment to attenuate muscle loss or enhance muscle regeneration. Additionally, muscle loss is highly correlated with comorbidities such as obesity, which can severely diminish quality of life.
“IMM01-STEM represents a paradigm shift in approaching age-related diseases like sarcopenic obesity, which involves both metabolic and inflammatory dysfunction,” states Erin Curry, PA-C, MPH, Director of Medical Affairs at Immunis.
IMM01-STEM is a novel, investigational secretome comprised of natural immunomodulators. Immunis’ groundbreaking multi-active biologic offers a multifaceted approach to combating these deleterious effects of aging.
“The published preclinical studies of IMM01-STEM in GeroScience and Aging Cell, have yielded a treasure trove of potential clinical applications and we are eager to explore how these data translate to humans,” adds Curry.
The Phase 2 study has five clinical sites that are actively recruiting patients. These sites include Hoag Orthopedics in Irvine and the National Institutes of Clinical Research (NICR) in Garden Grove and Pomona, California. Additionally, there are two more clinical sites open in Kansas at Johnson County Clinical Trials (JCCT) in Kansas City and Tekton Research in Wichita.
