Aemcolo® is a pharmaceutical drug product containing rifamycin SV formulated with the MMX® technology. Aemcolo® contains a broad spectrum, semi-synthetic, orally non-absorbable antibiotic, and has been approved in the US and in the EU for the treatment of traveler’s diarrhea caused by non-invasive E. coli strains.
The application of MMX® technology to rifamycin SV allows the antibiotic to be delivered directly into the colon, avoiding unwanted effects on the beneficial bacterial flora living in the upper portions of the gastro-intestinal tract. The specific dissolution profile of Aemcolo® tablets is thought to increase the colonic disposition of the antibiotic so that an optimized intestinal concentration is achieved thus avoiding its systemic absorption in the small intestine.
Aemcolo® is the first FDA approved antibiotic for the treatment of travelers’ diarrhea in over a decade and is now marketed by RedHill Biopharma in US.
In addition, Dr. Falk Pharma, our licensee, has received approval in EU through the European Decentralized Procedure (DCP) for Relafalk for the treatment of travelers’ diarrhea. In a phase 3 clinical study against ciprofloxacin in traveler’s diarrhea, patients treated with ciprofloxacin had a significant increase in the colonization rate by Extended Spectrum β-Lactamase-producing (ESBL) Escherichia Coli, whereas patients treated with Aemcolo® were not Extended-spectrum beta-lactamases (ESBL) are enzymes that confer resistance to most beta-lactam antibiotics, including penicillins, cephalosporins, and the monobactam aztreonam, also including many fourth generation cephalosporins.
This provides an important advantage in view of the recent concerns regarding the emergence of multi-drug resistant bacteria, whose infections are challenging to be treated.
The product has also shown an excellent safety profile, both in toxicology and in clinical studies. In order to expand the indications of the drug, a proof of concept dose ranging trial is being conducted with a new formulation in IBS-D in Europe. Due to the pharmacologic profile of the product, other indications are currently pursued in Minimal Hepatic Encephalopathy, Acute Uncomplicated Diverticulitis and Small Intestine Bacterial Overgrowth (SIBO) through Investigator Initiated Studies in the US.