Immunis, a clinical-stage biotechnology company developing multi-active secretome-based biologics, has announced positive interim results from its Phase 2 STEM-META study of IMM01-STEM in obese older adults experiencing muscle loss and metabolic dysfunction, the company said. According to the company, this double-blind, placebo-controlled trial evaluating the secretome biologic showed clinically meaningful improvements in physical function.
In the trial involving 47 obese seniors with reduced muscle function, Immunis said that subjects treated with IMM01-STEM demonstrated a 26 percent improvement in gait speed compared with placebo controls, an established indicator of mobility and overall health. The absolute change in gait speed for treated participants exceeded thresholds associated with improved quality of life at both four weeks and three months post-treatment, reaching gains of 0.12 m/s and 0.16 m/s respectively.
IMM01-STEM is a multi-active biologic derived from the secretome of partially differentiated stem cells that the company claims stimulates multiple cellular signalling pathways relevant to immune regulation, muscle regeneration and metabolic health without administering whole stem cells. According to Immunis, secretome-based therapy represents a novel class of cell-free biologics intended to address complex, age-related physiological declines.
The study continues to assess safety, body composition, metabolic and inflammatory markers, and remains ongoing. Immunis said that its preclinical and earlier data indicated potential benefits including increased lean mass, reduced fat mass and improved physical activity measures, forming the basis for further clinical investigation of IMM01-STEM in populations with musculoskeletal and metabolic diseases.
Immunis is also exploring the potential of its secretome biologic in additional patient groups and companion animal models, reflecting its broader strategy to develop regenerative and immune-modulating therapies.
