STEM-META: Targeting Muscle Performance
Immunis is continuing its safety and efficacy assessments of IMM01-STEM in addressing muscle performance in seniors with obesity and muscle weakness.
Preclinical data shows enhanced muscle quality and metabolism
Immunis is on the vanguard of developing therapeutics to address age-related muscle loss. In published preclinical aged mouse models, Immunis’ IMM01-STEM treatment increases whole-body lean mass and reduces fat mass, while increasing muscle size, enhancing muscle regeneration, and improving muscle function.
Read or check out the video below for the results from our publication in Aging Cell.
Stem cell secretome treatment improves whole-body metabolism, reduces adiposity, and promotes skeletal muscle function in aged mice
Fennel, Zachary J., Paul-Emile Bourrant, Anu Susan Kurian, Jonathan J. Petrocelli, Naomi M. M. P. de Hart, Elena M. Yee, Sihem Boudina, et al. “Stem Cell Secretome Treatment Improves Whole-Body Metabolism, Reduces Adiposity, and Promotes Skeletal Muscle Function in Aged Mice.” Aging Cell. (March 3, 2024): e14144. https://doi.org/10.1111/acel.14144.
The US-FDA granted permission for a Phase 2 clinical trial to test the efficacy of IMM01-STEM against a placebo on muscle performance in seniors with obesity and muscle weakness. Thus, IMM01-STEM may not only address the challenges of sarcopenic obesity, but it may also overcome the limitations of popular GLP-1 drugs by preserving muscle mass and function.
In the study of 47 obese seniors with loss of muscle functionality, IMM01-STEM demonstrated clinically relevant improvements to functionality, including the walking speed (gait speed), one of the most well-documented, validated indicators of muscle function and overall health.
Key interim results from the Phase 2 clinical trial:
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IMM01-STEM improved gait speed by 26% compared to placebo controls.
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The absolute change in gait speed for IMM01-STEM-treated subjects exceeded the clinically meaningful Quality-of-Life improvement of 0.1 m/s, reaching 0.12 m/s gained at 4 weeks and 0.16 m/s gained at 3 months post-treatment.
Gait speed, or the average speed at which an individual walks, is a measure of mobility, and a summary measure of physiologic reserve across multiple systems, including balance and coordination, musculoskeletal integrity, lower-extremity strength, and neurological, cardiovascular, and pulmonary function. 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.
Sarcopenia is a prominent contributor to declining health in older adults
Sarcopenia is the age-related loss of muscle mass, quality, and/or strength, which can begin developing in middle age, becoming more prominent after the age of 70 and manifesting as frailty. Frailty is characterized by impaired physical capabilities like coordination, balance, reaction time, and other attributes that limit the ability to recover from injury or illness. Additionally, frailty is the root of many secondary medical problems like falls, fractures, hospitalizations, and prolonged illness, making recovery more challenging. There are currently no pharmaceutical treatments to address sarcopenia, highlighting the need to promote muscle growth and restore muscle function in the vulnerable elderly populations.
Sarcopenia is also highly correlated with obesity. Sarcopenic obesity is a more severe condition than obesity or sarcopenia alone due to a greater health risk of cardiovascular disease, reduced bone mineral density, and all-cause mortality. While diet and exercise are the most effective approaches to managing sarcopenic obesity, these options may not always be feasible for older individuals.
GLP-1 inhibitor drugs have shown remarkable efficacy for rapid weight loss, but the long-term effects from the usage of these drugs are unknown. An emerging finding is that 20-50% of the total weight lost from GLP-1s is a result of a loss in lean body mass, which can include muscle. This is an important distinction as GLP-1 users may experience a decline in muscle size and function with extended use. Therefore, seniors who are already at a greater risk for sarcopenia may exacerbate muscle loss with GLP-1s.
