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Regulus Presents Additional Interim Data on RG-101 at International Liver Congress™ (ILC 2016)

LA JOLLA, Calif., April 15, 2016 /PRNewswire/ -- Regulus Therapeutics Inc. (NASDAQ: RGLS), a biopharmaceutical company leading the discovery and development of innovative medicines targeting microRNAs, today announced additional interim results from one of the company's ongoing Phase II studies of RG-101 for the treatment of Hepatitis C Virus infection (HCV) during an oral presentation at the International Liver Congress 2016 (ILC 2016) taking place April 13-17 in Barcelona, Spain. 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).

Today, Regulus reported longer-term follow up results across all arms of the ongoing study:

Follow-Up After 2nd
Dose of RG-101

RG-101 +

Harvoni®

RG-101 +

Olysio®

RG-101 +

Daklinza™

Week 8

21/21 (100%)

21/21 (100%)

20/22* (90.9%)

Week 12

14/14 (100%)

14/15* (93.3%)

12/12 (100%)

Week 16

9/9 (100%)

8/9* (88.9%)

9/9 (100%)

Week 20

2/2 (100%)

2/2 (100%)

2/2 (100%)

Week 24

1/1 (100%)

2/2 (100%)

-- (--)

Response defined as HCV RNA viral load below LLOQ using RealTime HCV Assay (Abbott) with LLOQ = 12

*Includes one relapse patient in the Olysio arm (week 12) and one relapse patient in the Daklinza arm (week 8)

"We believe the data reported at the ILC meeting further demonstrate the clinical utility of RG-101 to shorten oral HCV treatment regimens to just four weeks," said Paul Grint, M.D., President and CEO of Regulus. "With interim data now through 24 weeks of follow-up, the consistent trend in efficacy and safety is encouraging, which supports the potential of RG-101 to become a backbone agent in combination with all classes of oral therapies. Throughout the year, we look forward to obtaining more data from multiple studies across our broad Phase 2 development program."

To date, RG-101 has been generally well tolerated with the majority of adverse events considered mild or moderate, and with no study discontinuations. Changes in pharmacodynamic markers are indicative of effective target engagement and consistent with the company's prior experience with miR-122 inhibition. The primary endpoint analysis (12 week follow up) for all 79 patients in the study is anticipated to be reported in late Q2 2016.

The investigator slides presented at the ILC 2016 meeting are available on the investor relations page of Regulus' website at www.regulusrx.com.

Conference Call & Webcast Information

Today at 8:00 a.m. EDT, Regulus will host a conference call and webcast to discuss the ILC 2016 interim results. A live webcast of the call will be available online at www.regulusrx.com. To access the call, please dial (877) 257-8599 (domestic) or (970) 315-0459 (international) and refer to conference ID 89822720. To access the telephone replay of the call, dial (855) 859-2056 (domestic) or (404) 537-3406 (international), passcode 89822720. The webcast and telephone replay will be archived on the company's website following the call.

About Hepatitis C Virus Infection (HCV)

Hepatitis C is a result of a hepatocyte specific infection induced by the virus known as HCV...


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