Immuron Clinical Trials Update
- Completion of in-patient phase of campylobacter clinical program is a significant milestone
- Pre-IND submission to the FDA planned for H1 2024 indicates progress in regulatory process
- Manufacture of IMM-529 drug substance targeting C. Diff bacteria completed, marking advancement in therapeutic product development
- Agreements with Monash University and VivoPharm Global Preclinical Services for vaccine manufacture and toxicity study demonstrate collaboration for research and development
- Progress in Travelan clinical study with expected headline results in June 2024 shows advancement in clinical trial process
- None.
Insights
The completion of the in-patient phase for Immuron Limited's campylobacter clinical program and the advancement towards a Pre-IND submission for IMM-529 represent significant milestones in the company's product development pipeline. The successful manufacture of the IMM-529 drug substance and the progression of the Travelan® clinical study are indicative of the company's commitment to addressing infectious diseases, particularly gastrointestinal infections caused by Campylobacter and Clostridioides Difficile.
From an industry perspective, these developments are noteworthy as they signal potential future revenue streams and opportunities for market expansion, contingent upon successful trial outcomes and subsequent FDA approval. Clinical trials, especially Phase 2, are critical for establishing safety and efficacy, which can significantly influence investor confidence and stock valuation. The focus on prevention and reduction of moderate to severe diarrhea positions the company's products within a therapeutic area that has a clear unmet medical need, potentially leading to a strong market uptake if approved.
Investors and stakeholders should be cognizant of the inherent risks associated with clinical trials, including the possibility of negative outcomes or delays in the regulatory approval process. However, positive trial results could lead to increased partnership opportunities, licensing deals, or even acquisition interest from larger pharmaceutical entities.
The use of a controlled human infection model (CHIM) in these Phase 2 clinical trials is a strategic approach to assess the protective efficacy of the investigational products. CHIM studies are a powerful tool in vaccine development, allowing researchers to study diseases and test vaccines under controlled conditions. The primary efficacy outcome focusing on the prevention or reduction of moderate to severe diarrhea is a tangible clinical endpoint that, if met, could provide substantial evidence of the product's benefit.
Furthermore, the targeting of toxin B, spores and vegetative cells of Clostridioides Difficile by IMM-529 is of particular interest, as recurrent C. Diff infections are a significant clinical challenge. The drug's unique mechanism of action could set it apart from existing treatments and provide a competitive advantage in the market.
It is also worth noting that the partnerships with Monash University and VivoPharm Global Preclinical Services for manufacturing and toxicity studies demonstrate Immuron's collaborative approach to product development, leveraging external expertise to enhance their research capabilities.
Immuron Limited's progression through the clinical trial phases and the planned Pre-IND submission to the FDA are critical events that can influence the company's financial trajectory. The costs associated with these stages are substantial and successful completion can lead to an inflow of capital, either through strategic partnerships or the capital markets.
The biopharmaceutical sector is highly speculative and the outcomes of clinical trials can significantly impact a company's stock price. Investors often closely monitor trial results for indications of potential commercial success. Immuron's announcement of anticipated headline results in H2 2024 for the campylobacter clinical study and in June 2024 for the Travelan® study provides a timeline for potential stock volatility.
While these developments are promising, it is important for investors to assess the company's burn rate and cash reserves to sustain operations until the products potentially reach the market. Additionally, considering the competitive landscape and the anticipated market size for these treatments can provide further context for the potential return on investment.
Highlights:
- US Naval Medical Research Command (NMRC) campylobacter clinical program completes in-patient phase
- Manufacture of IMM-529 drug substance to support the Pre-IND information package has been completed
- Pre-IND submission to the U.S. Food and Drug administration (FDA) planned for H1 2024
- Travelan® clinical study inpatient phase completed and 6 month follow up visits planned
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.
The NMRC has recently completed the in-patient stage of the campylobacter challenge clinical study. 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. U.S. A total of 30 participants were enrolled in the study, of which 27 participants were dosed with either the Investigational Medical Product or placebo and all subjects were challenged with Campylobacter. All study volunteers have now been treated with antibiotics and discharged from the clinic. The study participants will return as outpatients for several follow-up visits, with the last patient last visit scheduled to be completed in June 2024. 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 primary efficacy outcome is prevention and/or reduction of moderate to severe diarrhea. ClinicalTrials.gov Identifier: NCT06122870.
Immuron‘s manufacturing campaign for a new therapeutic product which targets the Clostridioides Difficile (C. Diff) bacteria, IMM-529 drug substance was completed in December 2023 by CSIRO Agriculture and Food. IMM-529 is the second therapeutic drug candidate the company is planning to take into the clinic and has been specifically developed to target (i) toxin B, (ii) spores and (iii) vegetative cells of Clostridioides Difficile (C. Diff) which are thought to be the primary cause of C. Diff disease recurrences. A research services agreement has recently been executed with Monash University to assist with vaccine manufacture and stability testing of the Investigational Medical Product to support the pre-IND information package. A research services agreement has also been executed with VivoPharm Global Preclinical Services to conduct a GLP compliant toxicity study in rodents. The study protocol has been submitted and approved by the Animal Ethics Committee and the study is planned to commence in Q1 2024. The company is working towards submitting a Pre-IND information package to the U.S. Food and Drug Administration (FDA) in H1 2024.
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. The double-blind study was separated into two cohorts of approx. 30 subjects (60 in total) dosed with Travelan or placebo for two days prior to challenge continuing for a total of 7 days. All study participants were challenged with Escherichia coli, monitored for symptoms and treated with antibiotics. Safety data at two weeks and 4 weeks post challenge has been collected and the final 6 month follow up interviews will be initiated in January 2024 and are expected to be completed in April 2024. Headline results from the clinical trial are anticipated to be reported in June 2024. 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.
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 |
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
FAQ
What is the latest update from Immuron Limited (IMC; IMRN)?
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What is the primary efficacy outcome of the Phase 2 clinical trial for the new product manufactured by Immuron?
What is the status of the manufacture of IMM-529 drug substance?
What agreements have been made by Immuron Limited for research and development?
What are the expected headline results from the Travelan clinical study?
