Immunis, Inc., a clinical-stage biotechnology company, has successfully completed a Phase 1/2a clinical trial of IMM01-STEM, a novel multi-active biologic designed to address age and disease-related immune dysregulation. The trial focused on the safety, tolerability, and preliminary efficacy of IMM01-STEM in reversing muscle atrophy in older adults with knee osteoarthritis. Initial data suggest positive outcomes with no reported severe adverse events among the nine participants. A manuscript detailing the complete results is currently in development and expected to be published early next year.
Building on the promising findings, Immunis is already planning a Phase 2b clinical trial, STEM-MYO, to further investigate the functional efficacy signals observed in the Phase 1/2a study. This larger, randomized, controlled study will again focus on elderly individuals with sarcopenic knee osteoarthritis.
Concurrent with the STEM-MYO program, Immunis has received FDA clearance for a separate Phase 2 clinical trial, STEM-META. This trial will evaluate the efficacy of IMM01-STEM compared to a placebo in elderly individuals with sarcopenic obesity, specifically focusing on improvements in muscle and overall physical function. The goal is to enhance quality of life by restoring physical capabilities, potentially reducing fall risk, lessening reliance on caregivers, and enabling continued workforce participation.
Immunis is a privately held company dedicated to developing innovative immunomodulatory stem cell-derived biologics to combat the effects of age and disease-related immune decline. Their investigational product line utilizes advanced technology to produce multi-active biologics, delivering a therapy comprised of natural, human immune modulators in physiologically relevant concentrations.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Ferry, a computer data scientist, focuses on the latest clinical trial industry news and trends.
