FDA Grants Clearance for Immunis' Phase II Sarcopenic Obesity Trial

Immunis, Inc., a clinical-stage biotech developing novel secretome therapeutics for age-related diseases and immune dysfunction, was recently granted permission by the FDA to proceed with its Phase II clinical trial testing its investigational secretome (IMMUNA) in reversing sarcopenic obesity. The news comes shortly after Immunis completed secretome-treatment of its third patient cohort in a Phase I/IIa clinical trial for age-related muscle atrophy (sarcopenia).

In the U.S., obesity rates have skyrocketed within the past few decades, with a heavy impact on the elderly population. According to the National Center for Health Statistics, the percentage of obese Americans aged 65+ has doubled from about 20% to 40% for both men and women. Age-related obesity is strongly linked with additional health concerns including diabetes and muscle loss, which can have detrimental effects on quality of life.

Recently, GLP-1 drugs have become popularized by celebrities and those looking for a "quick fix" to managing weight problems, but questions remain regarding their long-term effects on health. Scientific publications reported that about 20-50% of the total weight lost from these drugs is attributed to a decrease in muscle mass, not fat. This means that individuals who take GLP-1s over an extended period may experience a decline in muscle size and function over time. This is an area of concern as muscle loss is associated with an increase in falls, fractures, and comorbidities, accounting for more than $40 billion in annual health care costs in the U.S. alone.

Immunis is seeking to change this outcome with its investigational secretome, IMMUNA, which can reduce fat, while preserving muscle. This year, Immunis published preclinical data in Aging Cell supporting that IMMUNA increases whole-body lean mass and reduces fat mass, while increasing muscle size, enhancing muscle regeneration, and improving muscle function. Immunis' Phase I/IIa results demonstrate no adverse events attributable to drug, with a strong suggestion of enhanced muscle function resulting in an increased quality of life measurement, the 6-minute walk test. Immunis will conduct a follow-up Phase II clinical trial to test the efficacy of IMMUNA in combating sarcopenic obesity, in the hopes of increasing mobility and independence.

"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," explains Dr. Hans Keirstead, Chairman of Immunis.

About Immunis Inc.

Immunis is a private biotechnology company developing a novel immunomodulatory secretome product for the various manifestations of age and disease-related immune decline. The investigational product line leverages Immunis' leading-edge capabilities in secretome technology to deliver a product of all natural, all human immune modulators in their natural relative physiological concentrations. For additional information about Immunis' Phase I/IIa clinical trial please visit: https://immunisbiomedical.com/clinical-trials/

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