Regulus Therapeutics, Inc. Gets Seat At Hepatitis C Table With Impressive Phase 1 Results

October 22, 2014

By Riley McDermid, BioSpace.com Breaking News Staff

News that Regulus Therapeutics Inc has seen a breakthrough in its hepatitis C treatment sent shares of the stock skyrocketing more than 107 percent on Wednesday, as traders rushed in to get a piece of a promising biopharma market rally.

Regulus was clocking in at $14.03 in early afternoon trading, up 107.24 percent from the previous trading session.

Regulus announced earlier in the day that it “has demonstrated human proof-of-concept with a microRNA therapeutic from an ongoing clinical study evaluating RG-101, a wholly-owned, GalNac-conjugated anti-miR targeting microRNA-122 ("miR-122"), for the treatment of hepatitis C virus infection ("HCV")."

Interim results from the ongoing clinical study found that a single subcutaneous dose of 2 mg/kg of RG-101 as monotherapy resulted in “significant and sustained” reductions in HCV RNA in a varied group of patients, including difficult to treat genotypes and patients who experienced viral relapse after a prior IFN-containing regimen.

The study also found that RG-101 is safe, well tolerated and has a demonstrably favorable pharmacokinetic profile to date that could allow it to combine with oral direct-acting antiviral agents to treat HCV.

“[The data] is a significant milestone in Regulus' history, and represents a key achievement under our 'Clinical Map Initiative'," said Kleanthis Xanthopoulos, president and chief executive officer of Regulus, in a statement.

"We believe these interim data are exceptional and provide strong evidence to support the rapid advancement of RG-101 into future clinical studies, while presenting a clear opportunity for a potentially disruptive therapy to the current HCV treatment paradigm,” he said.