Immunis Reports First Phase 2 Data for Secretome-Based Biologic Showing 26% Improvement in Gait Speed in Obese Seniors
Key Insights
Immunis (search) announced positive interim results from the first-ever Phase 2 study of a secretome (search)-based biologic, IMM01-STEM, demonstrating a 26% improvement in gait speed compared to placebo in obese seniors with muscle loss (search).
The study of 47 participants showed clinically meaningful improvements in walking speed, with treated subjects gaining 0.12 m/s at 4 weeks and 0.16 m/s at 3 months post-treatment, exceeding the 0.1 m/s threshold for quality-of-life improvement.
IMM01-STEM represents a novel class of "cell-free cell therapies" derived from stem cell secretions that target multiple cellular pathways simultaneously, offering therapeutic benefits without the risks of administering actual stem cells (search).
Immunis (search), a clinical-stage biotechnology company, has announced positive interim results from STEM-META, the first-ever Phase 2 study of a secretome (search)-based biologic in humans. The double-blind, placebo-controlled trial demonstrated that IMM01-STEM significantly improved gait speed by 26% compared to placebo in obese seniors experiencing muscle loss (search) and metabolic dysfunction (search).
The study represents a milestone for secretome (search)-based biologics, a novel class of therapeutics derived from secreted stem cell factors that stimulate multiple cellular signaling pathways simultaneously. According to Dr. Hans Keirstead, Chairman of Immunis (search), this approach addresses a fundamental limitation in current drug development: "Most diseases arise from dysregulation of complex cellular signaling pathways that are too intricate to correct with a single agent; yet scientists have been largely focused on single-target therapeutic approaches."
Clinical Trial Results Show Meaningful Functional Improvements
In the study of 47 obese seniors with loss of muscle functionality, IMM01-STEM demonstrated clinically relevant improvements to functionality, with the absolute change in gait speed for treated subjects reaching 0.12 m/s gained at 4 weeks and 0.16 m/s gained at 3 months post-treatment. These improvements exceeded the clinically meaningful quality-of-life improvement threshold of 0.1 m/s.
Gait speed serves as a comprehensive measure of physiologic reserve across multiple systems, including balance and coordination, musculoskeletal integrity, lower-extremity strength, and neurological, cardiovascular, and pulmonary function. Dr. Nicole Berchtold, Principal Scientist at Immunis (search), noted that "gait speed being a key metric predicting biological age, physical and cognitive status, risk of hospitalization, disability and death."
Secretome Technology Offers Cell-Free Alternative
IMM01-STEM represents what researchers call "cell-free cell therapies" - biologics that deliver the therapeutic benefits of stem cell molecules without the risk of administering actual stem cells (search). The secretome (search) contains naturally balanced regenerative and immunomodulatory molecules designed to improve immune health and function, with the goal of mitigating muscle loss (search), improving muscle regeneration and bettering metabolism.
The clinical results build on preclinical placebo-controlled studies demonstrating that IMM01-STEM increased whole-body lean mass, reduced fat mass and decreased muscle fat while increasing muscle fiber area and the number of muscle stem cells (search), and enhancing collagen turnover, grip strength and overall physical activity in mice.
Addressing Age-Related Health Challenges
The research tackles pressing challenges for the expanding older-adult population, focusing on conditions that significantly impact independence and quality of life. Improving gait speed functionally benefits independence, quality of life, physical fitness, cognitive and cardiovascular health, and reduces the risk of falls, disability, hospitalization, institutionalization, and all-cause mortality.
STEM-META is an ongoing Phase 2, placebo-controlled, dose expansion study targeting safety parameters, body composition, and muscle function in seniors with obesity (search) and muscle weakness. The study also monitors additional metabolic, inflammatory and muscle-adipose crosstalk markers. Immunis (search) is concurrently exploring the potential of IMM01-STEM in other populations with musculoskeletal and metabolic diseases as well as companion animals such as canines.