Regulus Therapeutics Inc Reports, FDA has put Clinical Hold on Investigational New Drug RG-101

Carlsbad, California based Regulus Therapeutics Inc. is a biopharmaceutical company that is involved in discovery and development of pioneering medicines which target microRNAs. The company announced it has received a verbal notice from the U. S. Food and Drug Administration (FDA) which says its Investigational New Drug RG-101, which aims at treating chronic hepatitis C virus infection, has been placed on clinical hold.

The biopharmaceutical company anticipates receiving a formal letter regarding the clinical hold from the FDA in a period within thirty days. It plans to work carefully with the agency in seeking the release of the clinical hold.

Reportedly, the FDA's decision to put the clinical hold is related to the event of Regulus reporting a serious adverse event (SAE) of jaundice for the second time. The SAE was discovered in a HCV patient who suffers from end- stage renal disease and is on dialysis. The patient is enrolled in its on-going Phase I US study and suffered the condition 117 days after receiving single dose of RG-101.

Discovery of microRNAs in humans is rather a new finding and was one of the most exciting scientific breakthroughs in the last decade. The microRNAs are small RNA molecules which are usually 20 to 25 nucleotides in length. These do not encode proteins, instead they regulate gene expression. These molecules are considered as key regulators of the human genome.