Immuron Limited (ASX: IMC; NASDAQ: IMRN), a biopharmaceutical company based in Australia with a global reach, announced encouraging interim topline results regarding the effectiveness of Travelan® in preventing moderate to severe diarrhea induced by enterotoxigenic Escherichia coli (ETEC).
The company’s ongoing clinical study marks a significant step towards developing a prophylactic treatment for travelers’ diarrhea, addressing a critical need in public health and military settings.
Background and Clinical Study Details
Immuron received funding of AU $4.8 (USD $3.43) million from the U.S. Department of Defense to conduct a phase 2 controlled human infection model (CHIM) study evaluating the efficacy of Travelan® in preventing ETEC-induced diarrhea among deployed US troops visiting developing countries.
The study, conducted in a randomized double-blind, placebo-controlled manner, involved administering a single daily oral dose of 1200 mg of Travelan® or placebo to healthy volunteers two days prior to challenge with ETEC strain H10407, continuing for seven days.
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Interim Analysis and Key Findings
The interim analysis, encompassing data from 60 subjects who completed the inpatient challenge phase of the study, reveals promising outcomes:
- Travelan® dosed once daily demonstrated a reduction in ETEC-induced moderate to severe diarrhea compared to placebo
- The Travelan® group exhibited a 36.4% reduction in ETEC-induced moderate to severe diarrhea compared to the placebo group
Protective efficacy of once-daily dosing was approximately 50% as effective as the current recommended three times daily dosing regimen, showcasing strong results despite a lower-than-expected attack rate.
A noteworthy 66.7% protective efficacy against ETEC-induced severe diarrhea was observed in the Travelan® group.
Subjects in the Travelan® group showed a statistically significant reduction of 83.3% in the need for early antibiotic treatment post-challenge compared to the placebo group.
None of the subjects in the Travelan® group required intravenous rehydration post-challenge, contrasting with 100% in the placebo group.
Adverse events post-ETEC challenge were reduced by 55.6% in the Travelan® group compared to the placebo group.
Regulatory Pathway and Future Plans
Based on the positive interim results, Immuron plans to convene an end-of-phase 2 meeting with the U.S. Food and Drug Administration (FDA) to discuss the pivotal phase 3 registration strategy and planned clinical trials.
These discussions will include recommended dosing to support a Biologics License Application (BLA) for Travelan® as a prophylactic treatment for travelers’ diarrhea, a high-priority objective for the U.S. Military.
Additionally, Immuron is exploring non-dilutive funding opportunities to support the phase 3 clinical trials.
The company’s commitment to advancing Travelan® through regulatory approval processes underscores its dedication to addressing unmet medical needs and improving public health outcomes.
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Significant Milestone in Prophylactic Treatments
Immuron Limited’s interim results for Travelan® represent a significant milestone in the development of prophylactic treatments for travelers’ diarrhea.
With promising efficacy data and a clear regulatory pathway outlined, the company is poised to advance Travelan® into phase 3 clinical trials and potentially bring a much-needed solution to market.
As the company progresses towards regulatory approval, stakeholders will closely monitor further developments and anticipate the potential impact of Travelan® on public health and military preparedness.
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I’m Elizabeth Monroe, a writer who brings you stories from around the world. I’m passionate about sharing important global news and amplifying the voices of those often left unheard. Through my writing, I aim to make the world feel a bit closer and more accessible.
