Pisd
5月前
GUT disease my friends: Immuron Plans Phase 2 Trial for IMM-529 following FDA review
September 05 2024 - 11:54AM
Immuron Limited (ASX: IMC; NASDAQ: IMRN), an Australian based and globally integrated biopharmaceutical company, is pleased to announce that it has received favourable feedback from the United States Food and Drug Administration (FDA) on the pre-IND (investigational new drug) information package to support the clinical development of IMM-529.
Following the FDA’s guidance and feedback, the Company now plans to file an investigational new drug (IND) application for IMM-529 to prevent or treat Clostridioides difficile infection (CDI) during the first half of 2025, followed by a Phase 2 trial of IMM-529 in individuals with Clostridioides difficile infection.
The increased incidence of antibiotic resistant ‘superbugs’ has amplified the use of broad-spectrum antibiotics worldwide. An unintended consequence of antimicrobial treatment is disruption of the gastrointestinal microbiota, resulting in susceptibility to opportunistic pathogens, such as Clostridioides difficile (C. diff). Paradoxically, treatment of Clostridioides difficile infection (CDI) also involves antibiotic use, and the heavy reliance on antibiotics to control C. diff does not allow for the gut flora to regenerate and predisposes the patient to relapsing CDI. C. diff is currently the most common pathogen in healthcare-associated infections and was deemed an urgent threat in the Center for Disease Control and Prevention’s report on antibiotic resistance threats in the United States (CDC, 2019). CDI affects over 400,000 people in the US on a yearly basis, contributing to over 30,000 deaths in the US alone annually. This serious health threat has led to an urgent call for the development of new therapeutics to reduce or replace the use of antibiotics to treat bacterial infections.
To address this need, Immuron is developing IMM-529 as an adjunctive therapy in combination with standard of care antibiotics for the prevention and/or treatment of recurrent CDI. IMM-529 antibodies targeting C. diff may help to clear CDI infection and promote a quicker re-establishment of normal gut flora, providing an attractive oral preventative for recurrent CDI.
Immuron is collaborating with Dr. Dena Lyras and her team at Monash University, Australia to develop vaccines to produce bovine colostrum-derived antibodies. Dairy cows were immunised to generate hyperimmune bovine colostrum (HBC) that contains antibodies targeting three essential C. diff virulence components. IMM-529 targets Toxin B (TcB), the spores and the surface layer proteins of the vegetative cells (refer to MOA schematic - below).
This unique 3-target approach has yielded promising results in pre-clinical infection and relapse models, including (1) Prevention of primary disease (80% P =0.0052); (2) Protection of disease recurrence (67%, P
Pisd
5月前
Immuron Announces New U.S. Department of Defense Research Award for Naval Medical Research Command and Walter Reed Army Institute of Research to advance Travelan®
Highlights:
$3.5 (USD $2.3) million funding for NMRC and WRAIR approved by the U.S. Department of Defense to advance the development of Travelan.
Melbourne, Australia, August 16, 2024: Immuron Limited (ASX: IMC; NASDAQ: IMRN), an Australian based and globally integrated biopharmaceutical company is pleased to announce the funding of a new research agreement for the Naval Medical Research Command (NMRC), and Walter Reed Army Institute of Research (WRAIR) Silver Spring, MD, USA.
The focus of this new research agreement is to develop an enhanced formulation of Travelan potentially expanding the coverage of the product as a therapeutic measure against endemic military relevant diarrheal pathogens. This work will utilize the extensive experience of the US Department of Defense human infectious disease vaccine programs and will target key protective antigens of the major enteric bacterial pathogens Campylobacter, Shigella and Entertoxigenic E. coli strains not present in the current product formulation.
Immuron will now negotiate a sub award for collaboration with NMRC and WRAIR to advance this research.
The U.S Department of Defense has recognized the benefits of Immuron’s technology platform and has an established long-standing relationship with Immuron to evaluate the commercial over-the-counter bovine colostrum product Travelan for its specificity and effectiveness against diarrheal pathogens. As an extension of the current Shigella (WRAIR), ETEC and Campylobacter (NMRC) research programs the goal of this award is to identify and define pathways to formulate, characterize and perform pre-clinical testing of a military-relevant combined colostrum product.
Infectious diarrhea is the most common illness reported by travelers visiting developing countries and among US troops deployed overseas as indicated by the 2019 Department of Defense (DoD) Infectious Disease Threats Prioritization Panel. 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.
Pisd
1年前
Immuron achieves record quarterly Travelan® sales
Highlights:
- Record quarterly Travelan® sales of $1,550,240
- Total sales of A$1,565,767 in Q1, FY24
- $1,508,933 increase on Q1, FY23 sales
- 130% higher than pre-pandemic period Q1, FY20 sales
Melbourne, Australia, October 11, 2023: Immuron Limited (ASX: IMC; NASDAQ: IMRN), an Australian based and globally integrated biopharmaceutical company is pleased to announce record quarterly sales (unaudited net sales) of its over-the-counter gastrointestinal and digestive health immune supplement Travelan®.
Australia
Immuron previously reported (August 9, 2023) that short term stock outages of Travelan® in some wholesalers and pharmacies in the June 2023 quarter was resolved following receipt of GMP Clearance from the Therapeutic Goods Administration (TGA). Immuron has since supplied product to wholesalers who in turn have supplied retail pharmacies.
Sales of Travelan® increased to AUD $1,339,160 in Q1, FY24, compared to AUD $25,565 in Q1, FY23. Sales increased by $940,991 (236%) on the pre-pandemic peak period (Q1, FY20).
This increase partially reflects 3 months (May, June, July) of backorders accrued while awaiting GMP Clearance from the TGA.
Immuron anticipates continued demand for replenishment of Travelan® as retail pharmacies sell to consumers. Australian Bureau of Statistics: short term resident returns in July 2023 were 48% higher than July 2022 and approaching pre-pandemic levels (89% of July 2019)1. Cumulative short term resident returns in the 12 months to July 2023 were 77% of those in the pre-pandemic period 12 months to July 2019. 1
USA
Sales of Travelan® increased to AUD $211,080 in Q1, FY24, compared to AUD $16,614 in Q1, FY23. Sales were lower by $20,499 (-9%) on the pre-pandemic peak period (Q1, FY20).
International Trade Administration Total U.S. citizen international visitor departures from the United States in June 2023 increased 20.2% compared to June 2022 and were 99.4% of total departures in June 2019. 2
subslover
2年前
Immuron Receives FDA Approval for Travelan IND Application
December 23 2022 - 06:00AM
GlobeNewswire Inc.
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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.
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.
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). Recruitment is planned to be initiated in 1H 2023 with headline results from the clinical trial expected to be reported by year end 2023.
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 an increasing resistance to commonly prescribed antibiotics. In addition, travelers' diarrhea is now recognized by the medical community to result in post-infectious sequelae, including post-infectious Irritable Bowel Syndrome and several post-infectious autoimmune diseases. A preventative treatment that protects against enteric diseases, is a high priority objective for the US Military.
This release has been authorised by the directors of Immuron Limited.
COMPANY CONTACT:
Steven Lydeamore
Chief Executive Officer
Ph: +61 (0)3 9824 5254
info@immuron.com
For more information visit: http://www.immuron.com
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