 |
|
|
| |
A Single Subcutaneous Dose of 2 mg/kg or 4 mg/kg of RG-101, a Galnac-Conjugated Oligonucleotide with Antagonist Activity against miR-122, Results in Significant Viral Load Reductions in Chronic Hepatitis C Patients
|
| |
| |
AASLD: Towards a Single Treatment Cure for HCV: Reformulation of the Pangenotypic NS5B NNI GSK2878175 as a Long Acting Parenteral (LAP) - (11/21/16)
GSK & Regulus "plan to conduct a multi-centered, randomized, dose-ranging Phase II study evaluating the combination of RG-101 and GSK's long-acting parenteral ("LAP") formulation of GSK2878175 as a potential single-visit cure in patients chronically infected with HCV. This study will be conducted outside the United States and is planned to begin in the fourth quarter of 2016. Based on predicted enrollment rates, interim results from this expanded collaboration should be available in the second half of 2017, enabling a potential initiation of a pivotal study in late 2017."
BOSTON, Nov. 11, 2016 /PRNewswire/ -- Two injections of RG-101, in combination with a four-week course of direct-acting antiviral (DAA) therapy, has been shown to clear hepatitis C in patients at both 12 and 24 weeks after treatment in the majority of patients, according to research presented this week at The Liver Meeting® - held by the American Association for the Study of Liver Diseases.
AASLD: RG-101 + DAAs - New Combination Therapy Could Cure Hepatitis C With Only 4 Weeks of Treatment - (11/16/16)
Regulus Reports Clinical Hold of RG-101.....
http://www.natap.org/2016/HCV/062716_05.htm
Reported by Jules Levin
AASLD 2016 Nov 11-15 Boston, MA
M.H. van der Ree 1, J.M.L. de Vree 2, F. Stelma 1, S.B. Willemse 1, M. van der Valk 1, S. Rietdijk 1,3, R. Molenkamp 4, J. Schinkel 4, S. Hadi 5, M. Harbers 5, A. van Vliet 5, J. Udo de Haes 5, P. Grint 6, S. Neben 6, N. Gibson 6 and H.W. Reesink 1
1.Dep. of Gastroenterology and Hepatology, Academic Medical Center, Amsterdam, The Netherlands
2.Dep. of Gastroenterology and Hepatology, University Medical Center Groningen, Groningen, The Netherlands
3.Dep. of Gastroenterology and Hepatology, Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands
4.Dep. of Medical Microbiology, Clinical Virology Laboratory, Academic Medical Center, Amsterdam, The Netherlands
5.PRA Healthsciences, Zuidlaren, The Netherlands
6.Regulus Therapeutics, San Diego, CA, USA
New HCV Drug RG-101.....http://www.natap.org/2016/HCV/012516_03.htm
Antisense therapy for hepatitis C virus infection -Commentary.....
http://www.natap.org/2013/HCV/011314_07.htm
New Hepatitis C Drug, RNAi drugs: microRNA-122
http://www.natap.org/2013/HCV/033013_02.htm
Some experts worry that because microRNA-122 affects certain liver functions - including cholesterol synthesis - a drug inhibiting the microRNA might cause serious side effects. But patients in this trial showed only mild effects. In the body, miravirsen has a half-life of roughly 30 days, Janssen says, suggesting that it might work as a monthly injection. Pairing it with another medicine might work even better, he adds. The new drug may dodge viral resistance to current drugs because it targets the host, not the virus. Micromanaging Hepatitis C Virus microRNA mIR-122 Editorial http://www.natap.org/2013/HCV/033013_03.htm
New HCV Drug RG-101.....http://www.natap.org/2016/HCV/012516_03.htm......LA JOLLA, Calif., Jan. 21, 2016 /PRNewswire/ -- Regulus Therapeutics Inc. (NASDAQ: RGLS), a biopharmaceutical company leading the discovery and development of innovative medicines targeting microRNAs, today announced key 2016 programmatic goals to advance RG-101, Regulus' wholly-owned therapy for the treatment of HCV. RG-101 is a GalNAc-conjugated anti-miR targeting miR-122, a host factor for HCV infection. Regulus' Phase II program and development strategy for RG-101 includes evaluating RG-101 in combination studies with different approved direct-acting anti-HCV agents (DAAs), in combination with an investigational oral DAA that can be formulated into a Long Acting Parenteral formulation for injection (LAP) providing the potential for a single-visit therapy, and in certain underserved HCV patient populations.
"Regulus begins 2016 with a multi-faceted clinical development plan for RG-101 in both Europe and the United States which we believe, if successful, will position our lead microRNA therapeutic well against the backdrop of the rapidly evolving HCV landscape," said Paul Grint, M.D., President and CEO of Regulus. "Regulus aims to enhance the value of RG-101 by maturing its profile in combination with oral agents and in certain underserved patient populations and we look forward to reporting results from multiple studies throughout 2016."
RG-101 IN COMBINATION WITH 4 WEEKS OF ORAL DIRECT ACTING ANTIVIRAL THERAPY ACHIEVES HIGH VIROLOGIC RESPONSE RATES IN TREATMENT NAïVE GENOTYPE 1 AND 4 CHRONIC HEPATITIS C PATIENTS: INTERIM RESULTS FROM A RANDOMISED, MULTI-CENTER, PHASE 2 STUDY.......
http://www.natap.org/2016/EASL/EASL_14.htm
LA JOLLA, Calif., Feb. 17, 2016 /PRNewswire/ -- Regulus Therapeutics Inc. (NASDAQ:RGLS), a biopharmaceutical company leading the discovery and development of innovative medicines targeting microRNAs, today 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.
|
| |
|
|
|
|
|
