IRVINE, Calif.--(BUSINESS WIRE)--Immunis, Inc., a clinical-stage biotech developing novel, multi-active biologics for age and disease-related immune dysregulation, is proud to announce the successful completion of its Phase 1/2a clinical trial. The clinical study investigated the safety, tolerability, and preliminary efficacy of Immunis’ investigational therapy, IMM01-STEM, in reversing muscle atrophy in elderly individuals with knee osteoarthritis.
"Completing this clinical trial is a significant milestone for our team,” says Erin Curry, Director of Medical Affairs at Immunis. “The initial raw and observational data are encouraging, and none of our participants reported any severe adverse events, which is excellent news.”
The team is currently analyzing the clinical datasets from the nine participants. A manuscript is in preparation detailing the results of the investigation, with a projected publication for early next year.
"We are eager to proceed with the data analysis and are hopeful about the potential impact IMM01-STEM could have on patients suffering from age-related muscle atrophy," adds Curry.
Anticipating successful clinical results, Immunis is designing a Phase 2b clinical trial as a follow up for its STEM-MYO program. The aim is to confirm the suggested functional efficacy signals from the Phase 1/2a clinical trial in a larger randomized, controlled study in sarcopenic elderly with knee osteoarthritis.
Additionally, the USA FDA granted permission for Immunis to proceed with testing IMM01-STEM in a Phase 2 clinical trial for elderly individuals with sarcopenic obesity. This parallel STEM-META program will focus on the efficacy of IMM01-STEM against a placebo on muscle and overall physical function in seniors with obesity and muscle weakness.
“The goal is to improve quality of life. If we can restore a person’s physical capabilities, the downstream impact on their fall risk, reliance on caregiver support, and ability to remain in the workforce could be life-changing,” remarks Curry.
Immunis is a private biotechnology company developing a novel immunomodulatory stem cell-derived biologic for the various manifestations of age and disease-related immune decline. The investigational product line leverages Immunis’ leading-edge capabilities in the production of multi-active biologics to deliver a therapy of all natural, all human immune modulators in their natural relative physiological concentrations.
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