STEM-META: Targeting Muscle Performance
Immunis is planning a Phase 2 placebo-controlled clinical trial to continue safety and efficacy assessments of IMM01-STEM on addressing muscle performance in seniors with obesity and muscle weakness.
The significance of age-related muscle loss and obesity (sarcopenic obesity)
Sarcopenia is the age-related loss of muscle mass, quality, and/or strength, which is a prominent contributor to declining health in older adults. Sarcopenia 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 muscle loss rather than fat loss. 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.
Immunis aims to address sarcopenic obesity with multi-active biologics
Immunis is on the vanguard of developing therapeutics to address age-related muscle loss. In published preclinical 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.
A Phase 1/2a clinical trial measured the safety, tolerability, and preliminary efficacy of Immunis’ multi-active biologic in people with sarcopenia associated with knee osteoarthritis. There have been no serious adverse events attributable to IMM01-STEM, with a strong suggestion of enhanced muscle function. The clinical programs have since expanded to explore age-related muscle loss in the context of obesity.
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.
IMM01-STEM benefits muscle function and metabolism (preclinical data)
Immunis Scientific Advisory Board member, Professor Micah Drummond, published preclinical research in Aging Cell supporting that Immunis’ investigational secretome enhances muscle mass and strength in aged mouse models, while increasing metabolism and reducing fat.
Aged mice received intramuscular injections of IMM01-STEM twice a week, for four consecutive week, totaling 8 injections. Compared to control-treated, aged mice, IMM01-STEM increases whole-body lean mass and reduces fat mass, while increasing muscle size, enhancing muscle regeneration, and improving muscle function. These preclinical data demonstrate that Immunis’ novel therapy increases metabolism without compromising muscle mass.
The U.S. Food and Drug Administration granted Immunis permission to conduct a Phase 2 clinical trial investigating IMM01-STEM on muscle function in patients with sarcopenic obesity (age-related muscle loss and obesity).
Read the publication below or check out the video below for the results from our Aging Cell publication.
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.