IMRN Immuron Ltd

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

Form 6-K

 

REPORT OF FOREIGN PRIVATE ISSUER

PURSUANT TO RULE 13a-16 OR 15d-16 UNDER

THE SECURITIES EXCHANGE ACT OF 1934

 

For the Month of October 2023

 

Commission File Number: 001-38104

 

IMMURON LIMITED

(Name of Registrant)

 

Level 3, 62 Lygon Street, Carlton South, Victoria, 3053, Australia

(Address of principal executive office)

 

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.

 

Form 20-F ☒       Form 40-F ☐

 

Indicate by check mark whether by furnishing the information contained in this Form, the registrant is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934.

 

Yes ☐       No ☒

 

If “Yes” is marked, indicate below the file number assigned to the registrant in connection with Rule 12g3-2(b): 82-

 

 

 

IMMURON LIMITED

 

EXPLANATORY NOTE

 

Immuron Limited (the “Company”) published one announcement (the “Public Notices”) to the Australian Securities Exchange on October 18, 2023 titled:

 

-

“Travelan Clinical Study Cohort 2 commences”

 

A copy of the Public Notice is attached as an exhibit to this report on Form 6-K.

 

This report on Form 6-K (including the exhibit hereto) shall not be deemed to be “filed” for purposes of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) and shall not be incorporated by reference into any filing under the Securities Act of 1933, as amended, except as shall be expressly set forth by specific reference in such filing.

 

 

EXHIBITS

 

Exhibit Number		Description
99.1		Travelan Clinical Study Cohort 2 commences

 

 

SIGNATURE

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

 

	IMMURON LIMITED
Date: October 18, 2023	By:	/s/ Phillip Hains
		Phillip Hains
		Company Secretary

 

 

3

Exhibit 99.1

 

 

Travelan^® Clinical Study Cohort 2 commences

 

Highlights:

 

	●	Second cohort of 34 healthy volunteers enrolled in the Travelan® Clinical Trial

	●	Clinical Trial to examine a dosing regimen for Travelan® more suited to the US military has commenced the second cohort

	●	The clinical study 6 month follow up of Cohorts 1 and 2 anticipated to be completed in April 2024

●

Travelan® is known to protect against the onset of Traveler’s diarrhea (TD), the most common illness reported by travelers

 

Melbourne, Australia, October 18, 2023: Immuron Limited (ASX: IMC; NASDAQ: IMRN), an Australian based and globally integrated biopharmaceutical company is pleased to announce the second cohort of 34 participants have commenced the clinical trial to evaluate the efficacy of Travelan^® to prevent infectious diarrhea caused by enterotoxigenic Escherichia coli (ETEC).

 

The clinical study is being led by Principal Investigator Dr Mohamed Al-Ibrahim at the Pharmaron CPC FDA inspected Clinical Research Facility Inpatient Unit located in Baltimore, Maryland US. The Phase 2 clinical trial is designed to evaluate the safety and protective efficacy of Travelan^® compared to a placebo in a controlled human infection model (CHIM). The primary efficacy outcome is prevention and/or reduction of moderate to severe diarrhea. ClinicalTrials.gov Identifier: NCT05933525.

 

The first cohort in-patient stage of the study was completed in August 2023. Immuron received confirmation that a second cohort of 34 study participants were admitted to the Pharmaron inpatient facility and randomized to receive either Travelan^® or placebo. The inpatient phase for the second cohort will be completed by the end of October 2023. All study participants will return as outpatients for 2 weeks, 1 month and 6 month follow-up visits. Headline results from the clinical trial are anticipated to be reported in June 2024.

 

Infectious diarrhea is the most common illness reported by travelers visiting developing countries and among US troops deployed overseas. The morbidity and associated discomfort stemming from diarrhea decreases daily performance, affects judgment, decreases morale and declines operational readiness. The first line of treatment for infectious diarrhea is the prescription of antibiotics. Unfortunately, in the last decade, several enteric pathogens have demonstrated increasing resistance to commonly prescribed antibiotics. In addition, traveler’s diarrhea is now recognized by the medical community to result in post-infectious sequelae, including post-infectious irritable bowel syndrome (IBS) and several post-infectious autoimmune diseases. A preventative treatment that defends against infectious enteric diseases is a high priority objective for the US Military.

 

This release has been authorised by the directors of Immuron Limited.

 

- - - END - - -

 

 

 

 

COMPANY CONTACT:  

 

Steven Lydeamore

Chief Executive Officer

Ph: +61 (0)3 9824 5254

info@immuron.com    

 

About Travelan^®

 

Travelan^® is an orally administered passive immunotherapy that prophylactically reduces the likelihood of contracting traveler’s diarrhea, a digestive tract disorder that is commonly caused by pathogenic bacteria and the toxins they produce. Travelan^® is a highly purified tabletized preparation of hyper immune bovine antibodies and other factors, which when taken with meals bind to diarrhea-causing bacteria and prevent colonization and the pathology associated with traveler’s diarrhea. In Australia, Travelan^® is a listed medicine on the Australian Register for Therapeutic Goods (AUST L 106709) and is indicated to reduce the risk of Traveler’s Diarrhea, reduce the risk of minor gastro-intestinal disorders and is antimicrobial. In Canada, Travelan^® is a licensed natural health product (NPN 80046016) and is indicated to reduce the risk of Traveler’s Diarrhea. In the U.S., Travelan^® is sold as a dietary supplement for digestive tract protection.

 

About Traveler’s diarrhea

 

Traveler’s diarrhea is a gastrointestinal infection with symptoms that include loose, watery (and occasionally bloody) stools, abdominal cramping, bloating, and fever, Enteropathogenic bacteria are responsible for most cases, with enterotoxigenic Escherichia coli (ETEC) playing a dominant causative role. Campylobacter spp. are also responsible for a significant proportion of cases. The more serious infections with Salmonella spp. the bacillary dysentery organisms belonging to Shigella spp. and Vibrio spp. (the causative agent of cholera) are often confused with traveler’s diarrhea as they may be contracted while travelling and initial symptoms are often indistinguishable.

 

About Immuron

 

Immuron Limited (ASX: IMC, NASDAQ: IMRN), is an Australian biopharmaceutical company focused on developing and commercializing orally delivered targeted polyclonal antibodies for the treatment of inflammatory mediated and infectious diseases.

 

For more information visit: http://www.immuron.com

 

FORWARD-LOOKING STATEMENTS:

 

This press release may contain “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, each as amended. Such statements include, but are not limited to, any statements relating to our growth strategy and product development programs and any other statements that are not historical facts. Forward-looking statements are based on management’s current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition and stock value. Factors that could cause actual results to differ materially from those currently anticipated include: risks relating to our growth strategy; our ability to obtain, perform under and maintain financing and strategic agreements and relationships; risks relating to the results of research and development activities; risks relating to the timing of starting and completing clinical trials; uncertainties relating to preclinical and clinical testing; our dependence on third-party suppliers; our ability to attract, integrate and retain key personnel; the early stage of products under development; our need for substantial additional funds; government regulation; patent and intellectual property matters; competition; as well as other risks described in our SEC filings. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law.

 

 

 

 

 

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