CHIM

Immuron Announces Positive Results Support Travelan® progress to Phase 3 Clinical Trials in the US

Retrieved on: 
Thursday, March 7, 2024
CHIM, Placebo, USD, Otto, ETEC, Diarrhea, Gastrointestinal tract, Food, Treatment, BLA, Enterotoxigenic Escherichia coli, Bacteria, ASX, Food and Drug Administration, Patient, IMC, Disease, Biologics license application, Infection, Trial of the century, Immuron, Pharmaceutical industry

MELBOURNE, Australia, March 07, 2024 (GLOBE NEWSWIRE) -- Immuron Limited (ASX: IMC; NASDAQ: IMRN), an Australian based and globally integrated biopharmaceutical company is pleased to announce the interim topline results confirming that a single daily dose of Travelan® is effective in prevention of moderate to severe diarrhea following challenge with enterotoxigenic Escherichia coli (ETEC).

Key Points: 
  • This interim analysis summarizes the data for a total of 60 subjects who have completed the inpatient challenge component of this current clinical study.
  • Last patients last visits are anticipated to commence in April this year and final clinical study report will be completed in H2 2024.
  • To learn more about Phase 2 study design, read: U.S. Food and Drug Administration Step 3: Clinical Research
    IMM-124E (Travelan®) will be the first product developed with Immuron’s platform technology to proceed into Phase 3 clinical trials.
  • Immuron is in the process of exploring non-dilutive funding opportunities for these Phase 3 clinical trials.

Immuron Clinical Trials Update

Retrieved on: 
Friday, December 22, 2023
Spore, Clostridioides difficile, ASX, Immuron, Principal, Diarrhea, FDA, NMRC, Campylobacter, IMC, Johns Hopkins University, Trial of the century, MD, Agriculture, Clinical trial, GLP, Volunteering, Escherichia, Escherichia coli, CIR, CHIM, Patient, Monash University, Safety, JHU, Clostridioides, Pharmaceutical industry

MELBOURNE, Australia, Dec. 22, 2023 (GLOBE NEWSWIRE) -- Immuron Limited (ASX: IMC; NASDAQ: IMRN), an Australian based and globally integrated biopharmaceutical company is pleased to provide shareholders and the market with an update on the company’s clinical development portfolio.

Key Points: 
  • The NMRC has recently completed the in-patient stage of the campylobacter challenge clinical study.
  • Headline results from the clinical trial are anticipated to be reported in H2 2024.
  • The Phase 2 clinical trial is designed to evaluate the safety and protective efficacy of the new product manufactured by Immuron compared to a placebo in a controlled human infection model (CHIM).
  • The inpatient challenge phase of the Travelan clinical study led by Principal Investigator Dr Mohamed Al-Ibrahim at the Pharmaron CPC FDA inspected Clinical Research Facility Inpatient Unit located in Baltimore, Maryland US, has been completed.

Immuron Announces First Patients Enrolled in Campylobacter Challenge Clinical Study

Retrieved on: 
Monday, December 4, 2023
ASX, Immuron, Principal, IBS, Diarrhea, NMRC, ETEC, Campylobacter, Disease, IMC, Trial of the century, Johns Hopkins University, MD, Clinical trial, Enterotoxigenic Escherichia coli, Infection, Morale, CIR, CHIM, Gastroenteritis, Safety, JHU, Judgement, Pharmaceutical industry

MELBOURNE, Australia, Dec. 04, 2023 (GLOBE NEWSWIRE) -- Immuron Limited (ASX: IMC; NASDAQ: IMRN), an Australian based and globally integrated biopharmaceutical company is pleased to announce that the US Naval Medical Research Command (NMRC) has initiated the clinical evaluation of a new oral therapeutic targeting Campylobacter and Enterotoxigenic Escherichia coli (ETEC) developed in collaboration with Immuron. The NMRC has prioritized the clinical development of the study to evaluate the efficacy of the new therapeutic product to prevent infectious diarrhea caused by Campylobacter.

Key Points: 
  • The NMRC has prioritized the clinical development of the study to evaluate the efficacy of the new therapeutic product to prevent infectious diarrhea caused by Campylobacter.
  • The clinical study is being led by Principal Investigator Dr Kawsar Talaat, MD at the Johns Hopkins University (JHU) Center for Immunization Research (CIR) Inpatient Unit, located at the JHU Bayview Medical Campus, Baltimore, Maryland.
  • The dosing, challenge and the in-patient stage of the study is anticipated to be completed by the third week of December 2023.
  • The estimated study completion date (last participant, last visit) is June 2024 with headline results from the clinical trial expected to be reported in 2H 2024.

Immuron Announces Travelan® Clinical Study Cohort 2 commences

Retrieved on: 
Wednesday, October 18, 2023
ASX, Principal, ETEC, FDA, Trial of the century, Enterotoxigenic Escherichia coli, Morale, Immuron, Diarrhea, Disease, Judgement, CHIM, Clinical trial, Patient, IBS, Safety, Gastroenteritis, IMC, Pharmaceutical industry

MELBOURNE, Australia, Oct. 18, 2023 (GLOBE NEWSWIRE) -- 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).

Key Points: 
  • 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 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.

Pneumagen Announces Successful Clinical Proof of Concept for its Broad-Spectrum Antiviral Neumifil in Phase 2 Influenza Human Challenge Study

Retrieved on: 
Monday, October 2, 2023
COPD, RTI-113, Grenfell Tower Inquiry Phase 2, Chronic obstructive pulmonary disease, Control, Incidence, Patient, Risk, CHIM, Virus, Vaccine, Concept

Neumifil demonstrated a clinically significant reduction in the incidence of symptomatic influenza infection and in the severity of symptoms, which achieved statistical significance, compared to placebo.

Key Points: 
  • Neumifil demonstrated a clinically significant reduction in the incidence of symptomatic influenza infection and in the severity of symptoms, which achieved statistical significance, compared to placebo.
  • Neumifil was well tolerated with no new emergent adverse events or safety signals from the study compared to the first in human study.
  • Based on these positive clinical results, taken together with a pre-clinical data package demonstrating Neumifil’s activity against a broad range of viruses, Pneumagen now plans to advance Neumifil into further clinical studies.
  • Douglas Thomson, Chief Executive Officer at Pneumagen said: “We are extremely pleased that this Phase 2, Proof of Concept study met all of its key objectives.

Immuron Announces First Patients Enrolled in Travelan® Clinical Study

Retrieved on: 
Tuesday, July 25, 2023
IMC, Enterotoxigenic Escherichia coli, Use of Free and Open-Source Software (FOSS) in the U.S. Department of Defense, Diarrhea, Clinical trial, Gastroenteritis, ETEC, ASX, Judgement, Trial of the century, USU, IBS, Disease, Principal, Morale, FDA, CHIM, Safety, Pharmaceutical industry

MELBOURNE, Australia, July 25, 2023 (GLOBE NEWSWIRE) -- Immuron Limited (ASX: IMC; NASDAQ: IMRN), an Australian based and globally integrated biopharmaceutical company is pleased to announce the first cohort of 30 participants have been enrolled into the clinical trial to evaluate the efficacy of Travelan® to prevent infectious diarrhea caused by enterotoxigenic Escherichia coli (ETEC).

Key Points: 
  • 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 final 30 participants are anticipated to be enrolled into the study and complete the in-patient stage of the study by the end of October 2023.
  • The USU has reported that to date it has successfully enrolled 347 participants into the clinical study following the initiation of enrolment and approximately 260 have completed the study.

Immuron Business Update: Letter to Shareholders

Retrieved on: 
Thursday, June 22, 2023
Immuron, IMC, CDI, Luman Walters, ASX, Element, Infection, Clostridioides difficile, Gastrointestinal disease, Ageing, FDA, Recurrence, Phase, CHIM, Spore, Safety, Pharmaceutical industry

MELBOURNE, Australia, June 22, 2023 (GLOBE NEWSWIRE) -- Immuron Limited (ASX: IMC; NASDAQ: IMRN), an Australian based and globally integrated biopharmaceutical company that has developed two commercially available oral immunotherapeutic products for the treatment of gut mediated diseases, is pleased to provide the following business update.

Key Points: 
  • Dear Immuron Limited Shareholders (ASX: IMC; NASDAQ: IMRN),
    Immuron is pleased to announce that it has approved proceeding with IMM-529 cGMP manufacturing and to proceed with FDA pre-IND submission.
  • IMM-529 was developed for treatment of Clostridioides difficile (C. difficile) which is an anaerobic, spore-forming, gram-positive bacillus typically associated with gastrointestinal disease.
  • Transmission of C. difficile occurs by ingestion of spores either through person-to-person contact, animal-to-person contact or environment-to-person contact.
  • Base case yearly revenue in USA for IMM- 529 was estimated at US$92M for the target patient population (limited to second recurrence and later).

Immuron Initiates Recruitment of Travelan® Clinical Study

Retrieved on: 
Tuesday, May 30, 2023
IMC, Institutional review board, US Foods, Enterotoxigenic Escherichia coli, Use of Free and Open-Source Software (FOSS) in the U.S. Department of Defense, Diarrhea, Clinical trial, United States Army Medical Research and Development Command, Food and Drug Administration, ETEC, Gastroenteritis, ASX, Uniformed Services University of the Health Sciences, Trial of the century, IRB, Ethics, Ageing, FDA, Phase, CHIM, Food, Safety, Pharmaceutical industry, Immuron

MELBOURNE, Australia, May 30, 2023 (GLOBE NEWSWIRE) -- Immuron Limited (ASX: IMC; NASDAQ: IMRN), an Australian based and globally integrated biopharmaceutical company is pleased to announce that it has received approval from the U.S. Army Medical Research and Development Command (USAMRDC) Office of Human and Animal Research Oversight (OHRO) to proceed with the clinical trial to evaluate the efficacy of Travelan® to prevent infectious diarrhea caused by enterotoxigenic Escherichia coli (ETEC).

Key Points: 
  • The study has also been granted Institutional Review Board (IRB) human ethics and US Food and Drug Administration (FDA) approvals (ASX announcement December 23, 2022).
  • Immuron is now proceeding with the planned clinical trial in the United States and has initiated recruitment.
  • The clinical study will be conducted by Pharmaron CPC at its FDA inspected Clinical Research Facility Inpatient Unit located in Baltimore, Maryland US.
  • This is one of four clinical trials Immuron has, or is soon to, initiate.

Immuron Receives FDA Approval for Travelan IND Application

Retrieved on: 
Friday, December 23, 2022
Clinical trial, Investigational New Drug, Disease, Food, CHIM, ASX, National Institute of Cholera and Enteric Diseases, ETEC, Judgement, IMC, Diarrhea, Gastroenteritis, Morale, Trial of the century, US Foods, Safety, Irritable bowel syndrome, FDA, Enterotoxigenic Escherichia coli, IND, Phase, Protests of US military presence in Okinawa, Immuron, Pharmaceutical industry

MELBOURNE, Australia, Dec. 23, 2022 (GLOBE NEWSWIRE) -- Immuron Limited (ASX: IMC; NASDAQ: IMRN), an Australian based and globally integrated biopharmaceutical company that has developed two commercially available oral immunotherapeutic products for the treatment of gut mediated diseases, is pleased to announce that it has received approval from the US Food and Drug Administration to proceed with the clinical evaluation of Travelan. The Investigational New Drug (IND) application to evaluate the efficacy of a single dose of Travelan to prevent infectious diarrhea caused by ETEC is now active.

Key Points: 
  • The Investigational New Drug (IND) application to evaluate the efficacy of a single dose of Travelan to prevent infectious diarrhea caused by ETEC is now active.
  • As a result of this approval the company will proceed with the planned clinical trial in the United States.
  • The safety and protective efficacy of Travelan will be tested utilizing a controlled human infection-model clinical trial design.
  • Immuron is the sponsor of the IND, and the clinical study will be conducted by the Contract Research Organisation Pharmaron CPC, Inc (ASX announcement October 4, 2022) at its FDA inspected clinical research facility located in Baltimore, Maryland in the USA.

Immuron Submits IND Application To FDA for Travelan

Retrieved on: 
Monday, December 5, 2022
Enterotoxigenic Escherichia coli, Investigational New Drug, Phase, National Institute of Cholera and Enteric Diseases, Irritable bowel syndrome, FACP, Judgement, Clinical trial, ASX, Diarrhea, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, FDA, Immuron, US Foods, MB, Bachelor of Medicine, Bachelor of Surgery, Morale, CHIM, IMC, Gastroenteritis, Trial of the century, Principal, Drug discovery, ETEC, Disease, IND, Pharmaceutical industry

MELBOURNE, Australia, Dec. 05, 2022 (GLOBE NEWSWIRE) -- Immuron Limited (ASX: IMC; NASDAQ: IMRN), an Australian based and globally integrated biopharmaceutical company that has developed two commercially available oral immunotherapeutic products for the treatment of gut mediated diseases, is pleased to announce that it has submitted an Investigational New Drug (IND) application to the US Food and Drug Administration for Travelan®.

Key Points: 
  • The Phase II clinical trial will evaluate the efficacy of a single dose regimen of Travelan® in a controlled human infection model (CHIM) using the enterotoxigenic Escherichia coli (ETEC) strain H10407.
  • The clinical study aims to enrol up to 60 healthy adult subjects each will be randomly assigned to receive either a once-daily dose of 1200 mg of Travelan® (30 subjects) or placebo (30 subjects).
  • Immuron is the sponsor of the IND, and the clinical study will be conducted by the Contract Research Organisation Pharmaron CPC, Inc (ASX announcement October 4, 2022) at its FDA inspected clinical research facility located in Baltimore, Maryland in the USA .
  • This release has been authorised by the directors of Immuron Limited.