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 (IMM01-STEM, formerly 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, IMM01-STEM, which can reduce fat, while preserving muscle. This year, Immunis published preclinical data in Aging Cell supporting that IMM01-STEM 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 IMM01-STEM 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/

Cautionary Note Regarding Forward-Looking Statements

This communication contains statements that constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as applicable. Forward-looking statements include, but are not limited to, statements regarding our plans, beliefs, expectations and assumptions, as well as other statements that are not necessarily historical facts. You are cautioned that these forward-looking statements are only predictions and involve risks and uncertainties. Further, any forward-looking statement speaks only as of the date as of which it is made, and we do not intend to update or revise any forward-looking statements. This communication also contains market data related to our business and industry which includes projections that are based on several assumptions we believe are reasonable and most significant to the projections as of the date of this communication. If any of our assumptions prove to be incorrect, our actual results may significantly differ from our projections based on these assumptions. This communication is neither an offer to sell nor a solicitation of an offer to buy any of the securities described herein.

Contact email: contact@immunisbiomedical.com