Immunis Completes Phase 1/2a Trial for Muscle Atrophy

IRVINE, Calif.--(BUSINESS WIRE)--Immunis, Inc., a biotechnology company focused on developing innovative, multi-active biologics to address immune dysregulation related to aging and diseases, has successfully concluded its Phase 1/2a clinical trial. This study examined the safety, tolerability, and initial efficacy of IMM01-STEM, an experimental treatment aimed at mitigating muscle atrophy in older adults suffering from knee osteoarthritis.

"This milestone is a tremendous achievement for our team,” said Erin Curry, Director of Medical Affairs at Immunis. “The preliminary raw and observational data look promising, and we are pleased to report that there were no severe adverse events among the participants."

The research team is now diligently analyzing the data collected from the nine participants. A scientific manuscript detailing the findings is being prepared and is expected to be published early next year.

"We are excited to delve deeper into the data analysis and are optimistic about the potential benefits IMM01-STEM could offer to patients experiencing age-related muscle atrophy," Curry added.

Building on the encouraging results from the Phase 1/2a trial, Immunis is planning a Phase 2b clinical trial. This next phase, part of the STEM-MYO program, aims to validate the preliminary functional efficacy observed in the earlier trial through a larger, randomized, controlled study involving elderly individuals with sarcopenia and knee osteoarthritis.

Moreover, the United States Food and Drug Administration (FDA) has given Immunis the green light to advance to a Phase 2 clinical trial to test IMM01-STEM in elderly patients with sarcopenic obesity. This branch of the study, named the STEM-META program, will assess the effectiveness of IMM01-STEM compared to a placebo in improving muscle function and overall physical performance in seniors who are obese and have weakened muscles.

“Our ultimate goal is to enhance the quality of life for our patients. If we can improve their physical abilities, it could significantly reduce their risk of falls, decrease their dependence on caregivers, and help them stay active in the workforce,” Curry remarked.

About Immunis Inc.
Immunis is a privately-held biotechnology company dedicated to developing an innovative, stem cell-derived biologic that modulates the immune system to combat various forms of immune decline associated with aging and disease. Immunis’ products leverage advanced technologies to produce multi-active biologics, offering a therapy that includes all-natural, human immune modulators in their natural physiological concentrations.