Health and Healthcare

Regulus Therapeutics Soars Over Interim HCV Results

Chris Lange

Published: February 17, 2016 10:40 am

Last Updated: January 13, 2020 1:05 pm

Regulus Therapeutics Inc. (NASDAQ: RGLS) was one the of the biopharma companies leading the bulls in Wednesday’s regular trading session. This company reported positive interim results from its Phase 2 study for the treatment of hepatitis C virus (HCV) infection. 24/7 Wall St. pointed out a couple weeks ago that this would be one of the key FDA decisions to watch for in February.

The interim results were from the company’s ongoing Phase 2 studies of RG-101 for the treatment of HCV.  The study was designed to evaluate a shortened, four-week treatment regimen of RG-101 in combination with four weeks of once/daily approved anti-viral agents Harvoni, Olysio or Daklinza. The study has enrolled 79 treatment patients, and 38 patients had been evaluated so far through eight weeks of follow-up, and 97% of those patients 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. The primary endpoint analysis for all 79 patients in the study is anticipated to be reported in the late second quarter of 2016.

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, commented on the interim results:

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. In addition, I believe this novel approach might allow treating physicians to overcome compliance issues in a wide variety of patient populations.

Paul Grint, M.D., president and CEO of Regulus, added:

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. Based on the results announced today, Regulus intends to accelerate development of RG-101 given its promising potential to shorten treatment regimens.

Shares of Regulus were recently trading up nearly 33% at $8.33 on Wednesday, with a consensus analyst price target of $29.00 and a 52-week trading range of $5.14 to $21.22.