Immuron Ltd (NASDAQ:IMRN, ASX:IMC) has doubled on receiving positive interim topline results from its Phase 2 clinical trial of Travelan®, moving it closer to Phase 3 clinical trials in the United States.
The study's findings indicate significant protective efficacy of Travelan against enterotoxigenic Escherichia coli (ETEC)-induced diarrhoea, a common and debilitating condition affecting travellers.
Investors have welcomed the news with IMC shares as much as 104.55% higher to A$0.135, a high of more than two years, in ASX trading this morning. Almost 30 million shares changed hands in the first two hours of trade.
Landmark study
In a landmark study funded by a A$4.8 million (US$3.43 million) grant from the US Department of Defense, Travelan demonstrated a 36.4% reduction in cases of moderate to severe diarrhoea and a remarkable 66.7% efficacy against severe diarrhoea instances, compared to placebo.
Moreover, an 83.3% decrease in the need for early antibiotic treatment and a 55.6% reduction in adverse events among Travelan recipients underscore the treatment's potential as a prophylactic measure against travellers' diarrhoea.
This trial marks a significant milestone for Immuron, showcasing the single daily dose regimen's effectiveness and reinforcing Travelan's safety profile.
With the last patient visits expected in April 2024, and a complete study report anticipated in the second half of the year, these results pave the way for a pivotal Phase 3 registration strategy discussion with the U.S. Food and Drug Administration (FDA).
Immuron's innovative platform technology, which underpins Travelan®'s development, offers a new approach to preventing infectious diseases by blocking harmful pathogens and neutralising their toxins at mucosal surfaces.
Military application
The company is now seeking non-dilutive funding opportunities to further advance Travelan into Phase 3 trials, aiming to fulfil a critical need for effective prophylactic treatments against enteric diseases for travellers and military personnel alike.
The current findings not only confirm the efficacy of a simpler dosing regimen but also highlight the potential of Immuron's platform technology to combat a range of infectious diseases, positioning Travelan as a first-in-class oral antibody therapy for the prevention of ETEC-attributable diarrhoea.