Immuron seeking FDA approval for travelers’ diarrhea drug candidate
Australian biopharmaceutical company, Immuron Limited (ASX:IMC |NASDAQ:IMRN), plans to pursue clinical development of IMM-124E, its bovine polyclonal antibody drug candidate to prevent travelers’ diarrhea, through a formal FDA registration pathway.
IMC is focused on developing and commercialising oral immunoglobulin therapeutics for the treatment of gut mediated diseases and is pursuing a rapid path for clinical development of IMM-124E.
The company currently markets and sells Travelan® as a Therapeutic Goods Administration (TGA) listed medicine for prevention of travelers’ diarrhea in Australia, and also markets Travelan® in the US and Canada as a dietary supplement, and natural health product, respectively, for digestive tract protection.
Dr Gary S. Jacob, CEO of IMC highlighted that Travelan® and IMM-124E are one and the same. IMC is seeking FDA registration for IMM-124E as a drug to prevent travelers’ diarrhea, offering the potential for substantial sales benefits to Immuron.
Immuron forecasts IMM-124E’s potential peak annual sales at over US$100 million annually as an FDA approved drug to prevent TD.
Dr Jacob said, “This is an important strategic initiative towards enhancing commercialisation of the Travelan®/IMM-124E franchise”.
“We are moving aggressively forward to develop IMM-124E through the FDA by planning to file an Investigational New Drug (IND) application for prevention of travelers’ diarrhea, and pursuing with FDA a rapid path for its clinical development.”
IMM-124E recently completed a non-alcoholic steatohepatitis (NASH) trial and is currently being evaluated in ongoing clinical trials in alcoholic steatohepatitis (ASH) and pediatric non-alcoholic fatty liver disease (NAFLD).
IMC expect top-line data from the clinical trial of IMM-124E in ASH patients to be released by late Q2 2019.
Immuron is focused on establishing whether statistically-significant reductions in systemic lipopolysaccharide (LPS) endotoxin, observed in the completed Phase 2 trial in NASH patients, are observed in the ASH trial where lowering systemic LPS is the primary endpoint for the trial. Together with the completed trial in NASH patients, the company will be looking to determine IMM-124E’s potential in treating conditions where systemic LPS is believed to play a critical role.
Travelers diarrhea affects between 30% and 60% of over one billion international travellers every year and symptoms of nausea, vomiting, fever, stomach cramps and diarrhea, can last up to seven days. Travelan® has been shown in clinical studies to be an effective preventative against TD when taken as instructed.