Regulus Therapeutics (RGLS) Issues Encouraging Update from RG-101 Phase 2 in HCV; Plans Accelerated Development

February 17, 2016 7:33 AM EST

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Regulus Therapeutics Inc. (Nasdaq: RGLS) announced interim results from one of the company's ongoing Phase II studies of RG-101 for the treatment of Hepatitis C Virus infection (HCV). The study was designed to evaluate a shortened, four-week treatment regimen containing a subcutaneous administration of 2 mg/kg of RG-101 at Day 1 and Day 29, in combination with 4 weeks of once/daily approved anti-viral agents Harvoni®, Olysio®, or Daklinza™. The study enrolled 79 treatment naïve genotype 1 and 4 HCV patients (Harvoni® arm, n=27, Olysio® arm, n=27, Daklinza™ arm, n=25). Thirty-eight patients have been evaluated through 8 weeks of follow up. Ninety-seven percent of those patients (37/38) had HCV RNA viral load measurements below the limit of quantification. To date, RG-101 has been generally well tolerated with the majority of adverse events considered mild or moderate, and with no study discontinuations. For those patients through 12 weeks of follow-up, 100% remained below the limit of quantification (14/14). The primary endpoint analysis (12 week follow up) for all 79 patients in the study are anticipated to be reported in late Q2 2016.

"These sustained virologic responses demonstrate the potential ability of RG-101 to successfully reduce currently marketed oral treatment regimens to just four weeks, a major clinical breakthrough that the HCV field has not been able to achieve until today and I look forward to future results," said Eric Lawitz, M.D., Vice President, Scientific and Research Development, The Texas Liver Institute, and Clinical Professor of Medicine, University of Texas Health Science Center in San Antonio. "In addition, I believe this novel approach might allow treating physicians to overcome compliance issues in a wide variety of patient populations."

"The potent antiviral activity and sustained, durable responses observed from this interim analysis, provide evidence that RG-101 may have clinical utility as a potential backbone agent in combination with oral therapies to treat a wide range of HCV patients," said Paul Grint, M.D., President and CEO of Regulus. "Based on the results announced today, Regulus intends to accelerate development of RG-101 given its promising potential to shorten treatment regimens."

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