LA JOLLA, Calif., Nov. 12, 2015 /PRNewswire/ – Regulus Therapeutics Inc. (NASDAQ:RGLS), a biopharmaceutical company leading the discovery and development of innovative medicines targeting microRNAs (miR), today announced that the U.S. Patent and Trademark Office (“USPTO”) has granted patents related to Regulus’ most advanced microRNA therapeutics, RG-101, the company’s wholly-owned, GalNAc-conjugated anti-miR-122 being developed to treat HCV, and RG-012, an anti-miR-21 being developed to treat Alport syndrome.
- RG-101 – claims of the patent, owned solely by Regulus, cover the unconjugated anti-miR-122 component of RG-101, the GalNAc-conjugated anti-miR-122 of RG-101, and pharmaceutical compositions comprising either the unconjugated or conjugated compounds. Regulus’ patent portfolio related to RG-101 covers compositions and methods of use for the treatment of HCV in the United States and numerous foreign jurisdictions.
- RG-012 – claims of the patents, owned solely by Regulus, cover the anti-miR-21 component of RG-012, as well as pharmaceutical compositions and methods of treatment of [click to continue…]
Long-Acting Parenteral Formulation of GSK2878175 Being Developed; Co-Administration with RG-101 May Enable Single Visit Therapy for HCV Patients
LA JOLLA, Calif., Nov. 3, 2015 /PRNewswire/ — Regulus Therapeutics Inc. (NASDAQ:RGLS), a biopharmaceutical company leading the discovery and development of innovative medicines targeting microRNAs (miR), today announced that it has expanded development of RG-101, Regulus’ wholly-owned, GalNAc-conjugated anti-miR that targets miR-122, through a clinical trial collaboration and formulation development agreement with GlaxoSmithKline (“GSK”) (NYSE: GSK). The companies plan to conduct a Phase II study to evaluate the combination of RG-101 and GSK2878175, an investigational non-nucleoside NS5B polymerase inhibitor, for the treatment of HCV. Concurrently, GSK will work on developing a long-acting parenteral for injection (“LAP”) formulation of GSK2878175 which could improve patient compliance through reduced dosing intervals and potentially extend opportunities for HCV therapeutic intervention. This LAP formulation of GSK2878175 may be used in additional clinical trials together with RG-101 following completion of the planned Phase II study, although any additional studies are not covered by the collaboration agreement.
“We are pleased to work with GSK to advance the scientific understanding of the potential for a combination regimen co-administered all at once to treat HCV,” said Paul Grint, M.D., President and CEO of Regulus. “The study to be conducted [click to continue…]
LA JOLLA, Calif., Oct. 28, 2015 /PRNewswire/ – Regulus Therapeutics Inc., a biopharmaceutical company leading the discovery and development of innovative medicines targeting microRNAs, announced today that it has earned a fourth milestone payment in its collaboration with Biogen (NASDAQ: BIIB) related to progress in the companies’ research collaboration to identify microRNAs as biomarkers for multiple sclerosis (“MS”). To earn the milestone, Regulus’ microMarkersSM division used its robust technology platform and bioinformatics expertise to analyze the treatment effects of a Biogen relapsing MS drug on circulating microRNA profiles previously identified by Regulus.
“Our partnership with Biogen is one example of how Regulus microMarkersSM is researching the role and potential of microRNAs as biomarkers for numerous diseases. We’re excited to have identified a promising microRNA biomarker for MS, which we believe was a critical step to understand how microRNAs may change response to drug treatment,” said Paul Grint, M.D., President and [click to continue…]
Achieves Key ‘Clinical Map Initiative’ Goal for 2015 and Advances Orphan Disease Efforts
LA JOLLA, Calif., June 4, 2015 /PRNewswire/ – Regulus Therapeutics Inc. (NASDAQ: RGLS), a biopharmaceutical company leading the discovery and development of innovative medicines targeting microRNAs, announced today that dosing has begun in a first-in-human Phase I clinical study of RG-012, a single stranded, chemically modified oligonucleotide that binds to and inhibits the function of microRNA-21 (“miR-21″). RG-012 is being developed by Regulus in a strategic alliance with Genzyme, a Sanofi company, for the treatment of Alport syndrome, a life-threatening genetic kidney disease with no approved therapy. The Phase I clinical study is being conducted in the United States as a randomized, double-blind, placebo-controlled, single ascending dose study to evaluate the safety, tolerability and pharmacokinetics of subcutaneous dosing of RG-012 in healthy volunteers.
“Advancement of RG-012 into the clinic represents an important achievement under our ‘Clinical Map Initiative’ and further underscores our focus on discovering and developing novel microRNA therapies for orphan and rare diseases such as Alport syndrome,” said Paul Grint, M.D., President and Chief Executive Officer of Regulus. “We expect that the results from this first-in-human clinical study [click to continue…]
-Regulus Earns $2.5 Million Milestone Payment from AstraZeneca-
-RG-125 (AZD4076) is Regulus’ 3rd Clinical Candidate, Achieving Key ‘Clinical Map Initiative’ Goal for 2015-
LA JOLLA, Calif., April 7, 2015 /PRNewswire/ – Regulus Therapeutics Inc. (NASDAQ:RGLS), a biopharmaceutical company leading the discovery and development of innovative medicines targeting microRNAs, announced today the selection of RG-125 (AZD4076), a GalNAc-conjugated anti-miR targeting microRNA-103/107 (“miR-103/107″) for the treatment of Non Alcoholic Steatohepatitis (“NASH) in patients with type 2 diabetes/pre-diabetes, as a clinical candidate by AstraZeneca under the companies’ strategic alliance to discover, develop and commercialize microRNA therapeutics. RG-125 (AZD4076) is the first compound from the alliance to be selected for clinical development by AstraZeneca. In connection with the candidate selection, AstraZeneca will pay Regulus $2.5 million and will assume development of the program following acceptance of an Investigational New Drug application. In the near term, Regulus and AstraZeneca plan to submit key preclinical data on the RG-125 (AZD4076) program to be presented at a scientific meeting later this year and expect to initiate a Phase I study of RG-125 (AZD4076) in humans by the end of 2015.
“Regulus is very pleased that AstraZeneca has chosen to advance a microRNA therapeutic candidate from this exciting program toward the clinic. RG-125 acts as a novel insulin sensitizer which we believe may inform a differentiated development path to treat patients with complicated metabolic disorders,” said Neil W. Gibson, Ph.D., Chief Scientific Officer of Regulus. “RG-125 represents our third clinical development candidate to arise from our novel technologies in less than two years, which confirms the productivity of our platform, achieves a key goal under our ‘Clinical Map Initiative’, and underscores our leadership in the microRNA therapeutics field.”
Marcus Schindler, Head of Cardiovascular and Metabolic Diseases, Innovative Medicines and Early Development, AstraZeneca, said: “This is a tremendous achievement for our collaboration and an exciting step for AstraZeneca to be [click to continue…]