Travelan (IMM-124E) / Immuron - LARVOL DELTA

Clinical Study to Assess the Efficacy of IMM-124E (Travelan®) in a Controlled Human Infection Model (clinicaltrials.gov) - P2 | N=60 | Active, not recruiting | Sponsor: Immuron Ltd. | Trial completion date: Jul 2024 ➔ Jul 2025 | Trial primary completion date: Apr 2024 ➔ Jun 2025

Trial completion date • Trial primary completion date • Gastrointestinal Disorder • Infectious Disease

Trial to Evaluate Dietary Supplements to Maintain Gut Health During Travel (clinicaltrials.gov) - P=N/A | N=866 | Recruiting | Sponsor: Henry M. Jackson Foundation for the Advancement of Military Medicine | Trial completion date: Apr 2025 ➔ Aug 2025 | Trial primary completion date: Jan 2025 ➔ Jul 2025

Trial completion date • Trial primary completion date

Trial to Evaluate Dietary Supplements to Maintain Gut Health During Travel (clinicaltrials.gov) - P=N/A | N=866 | Recruiting | Sponsor: Henry M. Jackson Foundation for the Advancement of Military Medicine | Trial primary completion date: Oct 2024 ➔ Jan 2025

Trial primary completion date

Randomized, Double-Blind, Placebo-Controlled Study on the Efficacy and Safety of CampETEC Hyperimmune Bovine Colostrum (HBC) for the Prevention of Campylobacter-Mediated Diarrheal Diseases (ASTMH 2024) - "All participants were treated with azithromycin and ciprofloxacin when they met campylobacteriosis criteria or prior to discharge...Final determination of campylobacteriosis will be adjudicated by an independent committee. The protective efficacy of the CampETEC HBC will be determined upon unblinding."

Clinical • Breast Cancer • Infectious Disease

Pipeline of New Drug Treatment for Non-alcoholic Fatty Liver Disease/Metabolic Dysfunction-associated Steatotic Liver Disease. (PubMed, J Clin Transl Hepatol) - "Agents in this group include peroxisome proliferator-activated receptor agonists (e.g., pioglitazone, elafibranor, saroglitazar), bile acid-farnesoid X receptor axis regulators (obeticholic acid), de novo lipogenesis inhibitors (aramchol, NDI-010976), and fibroblast growth factor 21/19 analogs...Agents in this group include antioxidants (vitamin E), tumor necrosis factor α pathway regulators (emricasan, pentoxifylline, ZSP1601), and immune modulators (cenicriviroc, belapectin). The final group targets the gut (IMM-124e, solithromycin). Combination therapies targeting different pathogenetic pathways may provide an alternative to MASLD treatment with higher efficacy and fewer side effects. This review aimed to provide an update on these medications."

Journal • Review • Diabetes • Fibrosis • Hepatology • Immunology • Metabolic Disorders • Metabolic Dysfunction-Associated Steatotic Liver Disease • Oncology • Type 2 Diabetes Mellitus • FGF21 • TNFA

Trial to Evaluate Dietary Supplements to Maintain Gut Health During Travel (clinicaltrials.gov) - P=N/A | N=866 | Recruiting | Sponsor: Henry M. Jackson Foundation for the Advancement of Military Medicine | Trial primary completion date: Jul 2024 ➔ Oct 2024

Trial primary completion date

Clinical Study to Assess the Efficacy of IMM-124E (Travelan®) in a Controlled Human Infection Model (clinicaltrials.gov) - P2 | N=60 | Active, not recruiting | Sponsor: Immuron Ltd. | Recruiting ➔ Active, not recruiting | Trial completion date: Apr 2024 ➔ Jul 2024 | Trial primary completion date: Dec 2023 ➔ Apr 2024

Enrollment closed • Trial completion date • Trial primary completion date • Gastrointestinal Disorder • Infectious Disease

Bioactivity and efficacy of a hyperimmune bovine colostrum product- Travelan, against shigellosis in a non-Human primate model (Macaca mulatta). (PubMed, PLoS One) - "diarrheal infections. Future refinement and expansion of pathogens recognized by HBC including Travelan® could revolutionize current management of gastrointestinal infections and outbreaks in travelers' including military, peacekeepers, humanitarian workers and in populations living in endemic regions of the world."

Journal • Preclinical • Gastroenterology • Gastrointestinal Disorder • Infectious Disease

Hyperimmune bovine colostrum containing lipopolysaccharide antibodies (IMM124-E) has a nondetrimental effect on gut microbial communities in unchallenged mice. (PubMed, Infect Immun) - "Primarily, Travelan LPS antibody treatment decreased the ratio of Firmicutes/Bacteroidetes in gut microbial populations in unchallenged healthy mice. Further studies are required to examine the effect of Travelan LPS antibody treatment to engineer the microbiome in a diseased state and during recovery."

Journal • Preclinical • Gastrointestinal Disorder

Clinical Study to Assess the Efficacy of IMM-124E (Travelan®) in a Controlled Human Infection Model (clinicaltrials.gov) - P2 | N=60 | Recruiting | Sponsor: Immuron Ltd.

New P2 trial • Gastrointestinal Disorder • Infectious Disease

Immuron Q3 Sales reach 150% of 1H Sales (GlobeNewswire) - "Immuron Limited... announce the Q3 FY23 sales* results of its over-the-counter gastrointestinal and digestive health immune supplement Travelan® and Protectyn®. Global Q3 YTD sales of Travelan® and Protectyn® increased by 239% in FY23 to AUD $1.46 M, compared to AUD $430 k for the corresponding period in FY22. In Australia, Travelan® and Protectyn® sales for Q3 were AUD $577 k, a 101% increase on sales for 1H FY23 (AUD $287 k). Australian Travelan® and Protectyn® Q3 YTD FY23 sales were AUD $864 k representing a significant increase over the corresponding period in FY22 (AUD $80k)....North American Travelan® Q3 FY23 sales were AUD $298 k, greater than sales for 1H FY23 (AUD $297 k). North American Travelan® Q3 YTD FY23 sales were AUD $595 k, up by 70% on the corresponding period in FY22 (AUD $350 k)."

Sales • Inflammatory Bowel Disease • Ulcerative Colitis

"$IMRN Immuron Submits IND Application To FDA for Travelan https://t.co/LJt32PkO5R" (@stock_titan)

"$IMRN Immuron Update on IMM-124E SARS-CoV-2 Research https://t.co/ehBAqumMbX" (@stock_titan)

Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

"$IMRN US Department of Defense Uniformed Services University Clinical Evaluation of Travelan™ https://t.co/4BWui9WZxe" (@stock_titan)

Clinical

"$IMRN Immuron Travelan® Global sales up 216% https://t.co/Gh0fhfOno3" (@stock_titan)

"$IMRN IMM-124E – Demonstrates Antiviral T-Cell Immunity https://t.co/Qeqz138PAW" (@stock_titan)

Augmented antiviral T cell immunity by oral administration of IMM-124E in preclinical models and a phase I/IIa clinical trial: A method for the prevention and treatment of COVID-19. (PubMed, Drug Dev Res) - "Its high-safety profile makes it ideal for all disease stages and for pre-emptive therapy among medical personnel and other workers who are at a high risk of exposure to infections. The relatively low cost of HBC is expected to minimize care provider burdens, costs, and enable its global application."

Journal • P1/2 data • Preclinical • Cytomegalovirus Infection • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • IFNG

"$IMRN IMM124E – May offer a New modality for Inhibition of SARS-CoV-2 https://t.co/lu0sllKwrq" (@stock_titan)

Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

NASH clinical trial presentation and continued revenue growth (GlobeNewswire) - "Immuron Limited...today announced that the IMM-124E NASH clinical study findings will be presented by Professor Arun Sanyal at the American Association for the study of Liver Disease which will be held in San Francisco, California during the 9th – 13th of November 2018."

Metabolic Disorders • Non-alcoholic Fatty Liver Disease • Non-alcoholic Steatohepatitis

IMM-124E: Top-line data from P2 study (NCT02316717) for NASH in Q1 2018 (10th Annual Conference Biotech Showcase, Immuron)

P2 data • Metabolic Disorders • Non-alcoholic Steatohepatitis

IMM-124E: Top-line data from P2 study (NCT02316717) for NASH in Q1 2018 (10th Annual Conference Biotech Showcase, Immuron)

P2 data • Metabolic Disorders • Non-alcoholic Steatohepatitis

Immuron reports positive results in NASH clinical trial (GlobeNewswire) - P2, N=133; "IMM-124E demonstrated a statistically significant reduction in serum lipopolysaccharide (LPS) levels, when compared to placebo. LPS, is a bacterial endotoxin implicated in numerous peer review publications to drive liver inflammation, and to play a role in the progression of NASH...The results demonstrated that IMM-124E is retained within the gut lumen and not absorbed systemically....'This is truly a proof of concept for this first-in-class drug candidate,' said Arun Sanyal."

Media quote • P2 data • Metabolic Disorders • Non-alcoholic Steatohepatitis

Anti-LPS Antibody Treatment for Pediatric NAFLD (clinicaltrials.gov) - P2; N=40; Completed; Sponsor: Miriam Vos, MD; Recruiting ➔ Completed

Clinical • Trial completion

Administration of the hyper-immune bovine colostrum extract IMM-124E ameliorates experimental murine colitis. (PubMed, J Crohns Colitis) - "Our results demonstrate that oral treatment with IMM-124E significantly reduces intestinal inflammation, via decreasing the accumulation of pathogenic T cells and concomitantly increasing the induction of regulatory T cells. Our study confirms the therapeutic efficacy of IMM-124E in acute colitis and suggests that administration of IMM-124E might represent a novel therapeutic strategy to induce or maintain remission in chronic colitis."

Journal • Preclinical

Anti-LPS Antibody Treatment for Pediatric NAFLD (clinicaltrials.gov) - P2; N=40; Recruiting; Sponsor: Miriam Vos, MD; Trial completion date: May 2019 ➔ Dec 2019; Trial primary completion date: May 2019 ➔ Dec 2019

Clinical • Trial completion date • Trial primary completion date