Regulus Therapeutics Inc. revealed top-line results from the primary endpoint analysis of one of its ongoing Phase II studies of RG-101 for the treatment of Hepatitis C Virus infection (HCV). According to the company, the trial was meant to assess a shortened, four-week treatment regimen having a subcutaneous administration of 2 mg/kg of RG-101 at Day 1 and Day 29. This was in combination with 4 weeks of once/daily approved anti-viral agents Harvoni, Olysio, or Daklinza.
Regulus Therapeutics said the trial enrolled 79 treatment naïve genotype 1 and 4 HCV patients (Harvoni arm, n=27, Olysio arm, n=27, Daklinza arm, n=25). The primary endpoint of the trial is virologic response 12 weeks following conclusion of treatment.
The company indicated the results from this interim analysis demonstrated considerable virologic response through 24 weeks of follow-up. RG-101 plus Harvoni continued to demonstrate 100 percent response Rates. The combination of RG-101 plus either Olysio or Daklinza monotherapies have seen small numbers of viral relapse. The company said that the latest results included four new relapses: two in the Olysio arm (weeks 20 and 32) and two in the Daklinza arm (weeks 12 and 24).
Regulus said RG-101 in combination with four weeks of oral DAA therapy was generally well tolerated with the majority of adverse events considered mild or moderate, and with no study discontinuations. The company stated that commonly reported adverse events (AEs) included fatigue, headache, and injection site reactions.
The company’s President and CEO, Paul Grint, commented, “These data strengthen our conviction in the clinical utility of RG-101 to shorten oral HCV treatment regimens to four weeks or less. We are very encouraged by the consistent trend in safety and efficacy, which positions RG-101 to play an important role in advancing the current treatment options for HCV patients worldwide.”
In the pre-market on Tuesday, the stock traded 8.75 percent higher.
R. Chandrasekaran , Benzinga Staff Writer
June 07, 2016