IMMUNA (IMM01-STEM) / Immunis - LARVOL DELTA

Immunis Publishes Research Showing Body Fat Loss and Reversal of Liver Steatosis and Fibrosis, While Increasing Lean Muscle Mass, in Aged Models (Businesswire) - "IMM01-STEM significantly enhanced weight loss in obese mice by reducing the percentage of whole-body fat while increasing lean mass; IMM01-STEM significantly reversed liver steatosis and fibrosis in aged mice on a high fat diet, to levels similar to that of healthy controls; IMM01-STEM provided major metabolic benefits during weight loss, including better glucose tolerance and lower fasting insulin levels, with treated mice achieving metabolic profiles similar to healthy controls; IMM01-STEM preserves muscle mass and enhances muscle quality by increasing muscle fiber size, increasing blood capillary density, and reducing fibrosis."

Preclinical • Obesity

STEM-MYO: Safety and Tolerability of IMM01-STEM in Patients With Muscle Atrophy Related to Knee Osteoarthritis. (clinicaltrials.gov) - P1/2 | N=28 | Recruiting | Sponsor: Immunis, Inc. | Active, not recruiting ➔ Recruiting | Trial completion date: Dec 2025 ➔ Jun 2026 | Trial primary completion date: Sep 2025 ➔ Mar 2026

Enrollment open • Trial completion date • Trial primary completion date • Immunology • Muscular Atrophy • Osteoarthritis • Pain • Rheumatology

Safety and Tolerability of IMM01-STEM in Patients With Muscle Atrophy Related to Knee Osteoarthritis. (clinicaltrials.gov) - P1/2 | N=28 | Active, not recruiting | Sponsor: Immunis, Inc. | Completed ➔ Active, not recruiting | N=13 ➔ 28 | Trial completion date: Nov 2024 ➔ Dec 2025 | Trial primary completion date: Aug 2024 ➔ Sep 2025

Enrollment change • Enrollment closed • Trial completion date • Trial primary completion date • Immunology • Muscular Atrophy • Osteoarthritis • Pain • Rheumatology

Immunis’ Treats its First Patients for Sarcopenic Obesity (Businesswire) - "Immunis, Inc...announces that it has initiated treatment in several patients of its STEM-META Phase 2 clinical trial. The Phase 2 trial will assess the safety and tolerability of Immunis’ investigational therapy, IMM01-STEM, in older patients with sarcopenia (muscle atrophy) related to obesity."

Trial status • Muscular Atrophy • Obesity

Safety and Efficacy of IMM01-STEM Against Placebo on Muscle Performance in Seniors With Obesity and Muscle Weakness (clinicaltrials.gov) - P2 | N=55 | Recruiting | Sponsor: Immunis, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Genetic Disorders • Obesity • Sarcopenia

STEM-META-EAP: INTERMEDIATE-SIZE PATIENT POPULATIONS EXPANDED ACCESS to TREATMENT for SARCOPENIC OBESITY (clinicaltrials.gov) - P=N/A | N=0 | Temporarily Not Available | Sponsor: Immunis, Inc.

New trial • Genetic Disorders • Obesity • Sarcopenia

Safety and Tolerability of IMM01-STEM in Patients With Muscle Atrophy Related to Knee Osteoarthritis. (clinicaltrials.gov) - P1/2 | N=13 | Completed | Sponsor: Immunis, Inc. | Active, not recruiting ➔ Completed | Trial primary completion date: Nov 2024 ➔ Aug 2024

Trial completion • Trial primary completion date • Immunology • Muscular Atrophy • Osteoarthritis • Pain • Rheumatology

Safety and Efficacy of IMMUNA Against Placebo on Muscle Performance in Seniors With Obesity and Muscle Weakness (clinicaltrials.gov) - P2 | N=55 | Not yet recruiting | Sponsor: Immunis, Inc.

New P2 trial • Genetic Disorders • Obesity • Sarcopenia

Safety and Tolerability of IMMUNA(IMM01-STEM) in Patients With Muscle Atrophy Related to Knee Osteoarthritis. (clinicaltrials.gov) - P1/2 | N=13 | Active, not recruiting | Sponsor: Immunis, Inc. | Recruiting ➔ Active, not recruiting | Trial primary completion date: Aug 2024 ➔ Nov 2024

Enrollment closed • Trial primary completion date • Immunology • Muscular Atrophy • Osteoarthritis • Pain • Rheumatology

Safety and Tolerability of IMMUNA(IMM01-STEM) in Patients With Muscle Atrophy Related to Knee Osteoarthritis. (clinicaltrials.gov) - P1/2 | N=18 | Recruiting | Sponsor: Immunis, Inc. | Trial primary completion date: Dec 2023 ➔ Aug 2024

Trial primary completion date • Immunology • Muscular Atrophy • Osteoarthritis • Pain • Rheumatology

Safety and Tolerability of IMM01-STEM in Patients With Muscle Atrophy Related to Knee Osteoarthritis. (clinicaltrials.gov) - P1/2 | N=18 | Recruiting | Sponsor: Immunis, Inc. | Trial completion date: May 2023 ➔ Sep 2024 | Trial primary completion date: Feb 2023 ➔ Dec 2023

Trial completion date • Trial primary completion date • Immunology • Muscular Atrophy • Osteoarthritis • Pain • Rheumatology