Regulus Therapeutics Falls 12% Following HCV Clinical Study Results

Shares of Regulus Therapeutics Inc RGLS fell sharply at Monday’s open following the release of the company’s latest top-line HCV RG-101 clinical study.

The company noted that an additional year of follow-up has been added to the protocol to investigate the potential for a single administration of RG-101 due to the “longevity of the viral responses.”

According to the press release, top-line results from the 4 mg/kg dose cohort included “a mean viral load reduction of 4.8 log10 at day 29 (range -5.8 to -3.0.”

Additionally, “9 out of 14 patients had HCV RNA levels below the limit of quantification ( < 15 IU/ml) ("BLOQ")  at day 57 and these patients will be followed up to six months to investigate the potential for viral cures following the single administration of 4 mg/kg of RG-101,” according to the company

For the 2 mg/kg dose cohort, at day 85, “4 out of 14 treated patients with varied genotypes, liver fibrosis status and treatment history were Target Not Detected ("TND"); 2 of the treated patients that were BLOQ at day 57 relapsed shortly thereafter.”

"The profile of RG-101 has been significantly enhanced with these top-line data, making it an ideal pan-genotypic asset to investigate further in combination with all classes of oral agents to shorten the duration of treatment, increase patient compliance and maintain viral response, and also as monotherapy in certain underserved HCV populations," said Kleanthis G. Xanthopoulos, Ph.D., President and CEO of Regulus.

Regulus Therapeutics Inc recently traded at $15.17, down 10.03 percent.