The FDA has granted Immunis, Inc. clearance to proceed with a Phase II clinical trial evaluating IMMUNA, an investigational secretome, for the treatment of sarcopenic obesity. This follows the completion of Immunis' Phase I/IIa trial for age-related muscle atrophy (sarcopenia), which demonstrated no adverse events and suggested enhanced muscle function.
Addressing Sarcopenic Obesity
Sarcopenic obesity, characterized by the combination of age-related muscle loss and obesity, significantly impacts the elderly population. National Center for Health Statistics data indicates that obesity rates among Americans aged 65 and older have doubled in recent decades, affecting approximately 40% of both men and women. This condition is associated with increased risks of diabetes, reduced mobility, and diminished quality of life.
IMMUNA's Potential
IMMUNA is designed to reduce fat while preserving muscle mass. Preclinical data published in Aging Cell supports IMMUNA's ability to increase whole-body lean mass, reduce fat mass, enhance muscle size and regeneration, and improve muscle function. The Phase I/IIa trial results showed no adverse events attributable to the drug and suggested enhanced muscle function, as indicated by improvements in the 6-minute walk test.
Contrasting with GLP-1 Drugs
While GLP-1 drugs have gained popularity for weight management, concerns have been raised regarding their potential long-term effects, including muscle mass reduction. Scientific publications suggest that 20-50% of weight loss from GLP-1 drugs may be attributed to muscle loss, potentially leading to increased risks of falls, fractures, and comorbidities. Immunis aims to provide an alternative approach that preserves muscle mass while reducing fat.
Clinical Trial Objectives
The Phase II clinical trial will evaluate IMMUNA's efficacy in combating sarcopenic obesity, with the goal of increasing mobility and independence for patients. Dr. Hans Keirstead, Chairman of Immunis, stated, "Our innovative therapy shows promising results by simultaneously decreasing fat and enhancing muscle and muscle function. We're taking a significant stride towards improving healthspan."
