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Immuron Limited (NASDAQ: IMRN) is a pioneering Australian biopharmaceutical company that specializes in oral immunotherapy. The company focuses on developing and commercializing therapies utilizing polyclonal antibody products that target the human gut immune system and microbiome. Immuron's cutting-edge technology platform is designed to create orally stable therapeutics, offering potential 'oral targeted therapy' for a variety of immune-mediated and inflammatory disorders, including non-alcoholic steatohepatitis (NASH), diabetes, colitis, arthritis, inflammatory bowel diseases (IBD), irritable bowel syndrome (IBS), liver fibrosis, and other chronic conditions influenced by the immune system.
These disorders represent growing areas of unmet medical need, where oral targeted therapy drugs could provide significant benefits due to their high safety profiles and minimal absorption. Immuron has successfully brought one product to market, serving as proof of concept for its oral immune technology platform. Additionally, the company boasts a robust pipeline of products in various stages of clinical development.
One of Immuron's prominent products is IMM-124E, a proprietary immunomodulatory agent aimed at treating gastrointestinal immune-mediated diseases, including fatty liver diseases. The company operates in two primary segments: Research and Development, and Hyperimmune Products.
Recent developments highlight Immuron's progress in the market. The company has reported increased sales of its travel-related product, Travelan®, especially in markets such as the USA and Canada. Notably, sales in the USA have exceeded expectations following the product’s launch on Amazon. The company is also exploring non-dilutive funding opportunities for its Phase 3 clinical trials and has filed a provisional patent application with the U.S. Patent Office to protect its innovative findings.
Immuron's strategy involves continuing to harness its unique oral immunotherapy platform to address significant medical needs, focusing on partnerships and collaborations to enhance its product offerings and market reach.
Immuron Limited (ASX: IMC; NASDAQ: IMRN) announces the grant of a European Patent for the treatment and prevention of Clostridioides difficile infections. This patent, European Patent No. 2986316, enhances the company's intellectual property portfolio, complementing existing patents in Australia, New Zealand, and the United States. Clostridioides difficile infection (CDI) poses significant healthcare challenges, affecting up to 1.2% of hospitalized patients in the U.S., with annual costs approximating USD 4.8 billion. The growing incidence of CDI highlights the urgency for effective treatments as the population ages, particularly in Europe.
Immuron has received FDA approval for its Travelan Investigational New Drug (IND) application aimed at preventing infectious diarrhea caused by enterotoxigenic E. coli (ETEC). The IND is now active, and a clinical trial will commence in the US with plans to recruit 60 healthy volunteers. The trial will evaluate the efficacy of a single 1200 mg dose of Travelan in a controlled environment. Results are expected by year-end 2023. This treatment is significant for travelers and military personnel, given the rising antibiotic resistance affecting traditional treatments.
Immuron Limited (ASX: IMC; NASDAQ: IMRN) has submitted an Investigational New Drug (IND) application to the U.S. FDA for its product Travelan®. A Phase II clinical trial is set to evaluate a single dose regimen of Travelan® in a controlled human infection model, targeting infectious diarrhea caused by the enterotoxigenic Escherichia coli. The trial will involve 60 healthy subjects receiving either Travelan® or a placebo. Results are anticipated by the end of 2023, aligning with the U.S. military's need for preventative treatments against gastrointestinal diseases in troops.
Immuron Limited has completed a strategic investment of approximately £1.5 million (A$2.6 million) to acquire 17.5% of Ateria Health, a U.K. biotech company focused on gut health. This investment aligns with Immuron's growth strategy in the IBS market.
The company has been allotted 800,767 shares at £1.85 each and is entitled to a second board seat upon exercising a share option of £1.47 million by July 31, 2023. The strategic move is expected to enhance distribution synergies and support the launch of Ateria's product JUVIA™.
Immuron Limited (ASX: IMC; NASDAQ: IMRN), a biopharmaceutical company based in Australia, announced its participation in AusBioInvest 2022 in Perth on October 27, 2022. CEO Steven Lydeamore will present a slide deck detailing the company’s oral immunotherapeutic products for gut-mediated diseases. Investors can access the presentation on the company’s website. This press release has been authorized by the directors of Immuron Limited.
Immuron Limited (ASX: IMC; NASDAQ: IMRN) has signed a strategic investment agreement with Ateria Health, investing approximately £1.5m (A$2.6m) for a 17.5% stake. This agreement includes an option for further investment of £1.47m by July 31, 2023. Ateria Health specializes in gut health supplements, with its product JUVIA™ targeting irritable bowel syndrome (IBS). The partnership aims to enhance distribution channels for both companies in the UK, Australia, and North America.
Immuron Limited (ASX: IMC; NASDAQ: IMRN) has announced significant developments in its clinical research. A Master Service Agreement with US-based Pharmaron has been executed to initiate a Phase II clinical trial evaluating the single-dose regimen of Travelan® for protecting against travelers’ diarrhea caused by ETEC. This trial will enroll 60 healthy volunteers in the USA, with results expected in 2H 2023. The company also plans to submit an Investigational New Drug (IND) application to the FDA by the end of 2022, funded partly by a AU$6.2 million award from the US Department of Defense.
MELBOURNE, Australia, Aug. 29, 2022 (GLOBE NEWSWIRE) -- Immuron Limited (ASX: IMC; NASDAQ: IMRN) invites investors to a live webcast hosted by CEO Steven Lydeamore on September 7, 2022, at 9:00 AM AEST. The event aims to discuss the company's proprietary technology for gut-mediated disease treatment. Interested participants can register in advance for the webinar. This press release is authorized by the directors of Immuron Limited, which is focused on developing orally delivered polyclonal antibodies from bovine colostrum.
Immuron Limited (ASX: IMC; NASDAQ: IMRN) announced a strategic shift on August 19, 2022, deprioritizing its SARS-CoV-2 research to focus on advanced therapeutic drug candidates. The company is entering FY23 with a new CEO assessing its product portfolio and growth strategies. Immuron's previous research indicated the potential antiviral activity of its drug candidate IMM-124E against SARS-CoV-2, but the mechanism of action remains unclear. The evolving virus and treatment landscape pose challenges for clinical trials.
Immuron Limited (ASX: IMC; NASDAQ: IMRN) announced that the US Naval Medical Research Center (NMRC) received feedback from the US FDA regarding its Investigational New Drug (IND) application for a new oral therapeutic targeting Campylobacter and ETEC. The FDA identified insufficient information under 21 CFR 312.23 for assessing risks in proposed clinical studies, placing the IND on Clinical Hold. NMRC plans to address these comments and will seek a Type A meeting with the FDA within 30 days to discuss amendments and requirements for moving forward.
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