Immunis has reported interim Phase 2 clinical data showing improvements in physical function among older adults treated with its investigational IMM01-STEM secretome therapy. The placebo-controlled study assessed mobility outcomes in overweight seniors with muscle loss and metabolic dysfunction.
Phase 2 study evaluates cell-free secretome-based biologics
The findings come from STEM-META, a double-blind, placebo-controlled Phase 2 trial evaluating IMM01-STEM, a cell-free biologic derived from stem cell secreted factors. The study enrolled 47 obese older adults experiencing reduced muscle function.
According to Immunis, the trial represents one of the first Phase 2 clinical evaluations of secretome-based biologics, a class of therapies designed to influence multiple cellular signalling pathways without administering live stem cells.
Improvements observed in gait speed and mobility
Importantly, interim data showed that treatment with IMM01-STEM resulted in a 26% improvement in gait speed compared with placebo. Absolute gains in walking speed exceeded commonly cited thresholds for clinically meaningful change.
Gait speed is widely used as an indicator of mobility and overall physiological reserve, reflecting musculoskeletal, neurological, cardiovascular and pulmonary function.
Safety and broader implications for ageing-related conditions
Immunis stated that the observed improvements support further investigation of IMM01-STEM in age-related musculoskeletal and metabolic conditions. The company is continuing the STEM-META trial and is also exploring the therapy’s potential in other patient populations.
Meanwhile, the company referenced supporting preclinical studies showing effects on lean mass, fat composition and muscle fibre characteristics in animal models.
Ongoing research and next steps
The STEM-META study remains ongoing, with additional analyses expected as follow-up continues. Immunis has indicated that future research may explore both standalone and combination approaches involving IMM01-STEM.
Further information about the company is available on the Immunis website. Related coverage can be found in the Life Sciences Global News Biotechnology section.
