Aemcolo® 200 mg (containing 200 mg of rifamycin sodium, equivalent to 194 mg of rifamycin) is already approved in US and EU for the treatment of Travellers’ Diarrhea and is currently marketed by partners (RedHill Biopharma in the US and Dr. Falk Pharma in EU).
In January 2021, Cosmo announced the successful outcome of our Phase II Proof of Concept (POC) clinical trial of Rifamycin-MMX® 600mg in Irritable Bowel Syndrome with Diarrhea (IBS-D) showing a statistically significant improvement of the disease over placebo at the daily dose of 1,200 mg.
Two Investigator Initiated Trials (IIT) with the existing 200 mg formulation are currently on-going in the US for the treatment of Minimal Hepatic Encephalopathy and Small Intestine Bacterial Overgrowth (SIBO). An additional IIT study on Acute Uncomplicated Diverticulitis will start in 2022.