Immuron Ltd Stock Price, News & Analysis

Immuron Limited (ASX: IMC; NASDAQ: IMRN) has submitted a response letter to the US FDA regarding a clinical hold on their oral therapeutic targeting Campylobacter and ETEC. This was in response to FDA feedback from its review of the Investigational New Drug (IND) application submitted on July 26, 2022. A virtual meeting held on December 2, 2022, with the FDA, Naval Medical Research Center (NMRC), and Johns Hopkins University discussed the hold and how to address safety concerns. The FDA is expected to provide feedback on the submitted information package within 30 days.

Immuron Limited (ASX: IMC; NASDAQ: IMRN) has enrolled its first participants in the USU Travelan Clinical Trial Field Study, successfully randomizing 157 participants out of a target of 1302 volunteers. This clinical trial, conducted by USU's Infectious Diseases Clinical Research Program in partnership with the UK Ministry of Defense and the New York City Travel Clinic, aims to evaluate the efficacy of Travelan against Travelers’ Diarrhea. The study, designed to assess passive immunotherapy, is set to complete enrollment in roughly 18 months. Travelers' diarrhea poses significant health risks, especially for military personnel, highlighting the need for effective preventative strategies.

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.