Regulus Pharmaceuticals (RGLS) a biopharmaceutical company that discovers, designs and develop treatments targeting microRNAs announced interim results from one of the company’s ongoing Phase 2 studies of its hepatitis C virus (HCV) product RG-101.
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).
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.
From 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 we learn that the 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. In addition, Dr. Lawitz believes that 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 Regulu stated that “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.”
Regulus intends to accelerate development of RG-101 given its promising potential to shorten treatment regimens.”
We believe this is positive news that confirms the validity of the microRNA- related products and RNAi related products being developed by Regulus (RGLS), Alnylam (ALNY) and Ionis (IONS) formerly known as Isis.
We should not forget that Regulus is a joint venture between Alnylam and Ionis.
This group has been targeted for suppression as we reiterated in past newsletters a few months ago. They have large and promising pipelines and improved on their products safety and efficacy through extensive efforts spent on bringing better chemistry and better delivery.
This is needed good news. We will be happy to see the final results as successful as these interim results.
We believe our wish will be materialized