FDA Continues Clinical Hold on Investigational Hepatitis C Drug

RG-101 placed on clinical hold last year after a second reported case of jaundice.

The hepatitis C virus (HCV) drug candidate RG-101 is still on clinical hold by the FDA, according to Investopedia.

Regulus Therapeutics Inc’s HCV drug was placed on clinical hold in June 2016, due to a second case of jaundice reported during clinical trials.

Despite the drug manufacturer submitting a response following the hold, the FDA has requested final safety and efficacy data from an ongoing clinical trial. However, Regulus will be unable to present the data until the fourth quarter, because it will be unavailable until after 48 weeks of follow-up, Investopedia reported.

RG-101 is designed to target a specific microRNA in the liver, which aids the replication and translation of HCV in the liver. When the drug is used in combination with other treatment options, it is believed to shorten the treatment time for HCV.

The recent FDA update dropped Regulus’ stock price by more than 40% on Monday, and closed at $1.30 per share, which is a sharp drop from Friday’s close of $2.25, according to Investopedia.

Currently, Regulus has 2 other microRNA-targeting drugs in the product pipeline, which are expected to start human clinical trials this year.

RGLS5040 is being developed to treat cholestatic diseases, such as primary biliary cholangitis, and primary sclerosis cholangitis, along with congenital diseases, such as Alagille syndrome.

RGLS5040 has the potential to work as either a monotherapy or in combination with other drugs, Investopedia reported.

The second candidate, RGLS43 is being developed as a treatment for autosomal dominant polycystic kidney disease.

NASH therapy RG-125 and the Alport syndrome drug RG-012 are currently undergoing phase 2 trials.