Regulus Therapeutics

Regulus Earns $10.0 Million Milestone Payment from AstraZeneca and Achieves Key Goal for 2015

regulus therapeutics logoLA JOLLA, Calif., Dec. 18, 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-125(AZD4076), by its collaboration partner AstraZeneca. RG-125(AZD4076) is a GalNAc-conjugated anti-miR-103/107 oligonucleotide that has been shown to improve insulin sensitivity and glucose tolerance in animal models. RG-125(AZD4076) was jointly identified and selected as a clinical candidate in April 2015 by AstraZeneca under the companies’ strategic alliance to discover, develop and commercialize microRNA therapeutics. AstraZeneca will pay Regulus $10.0 million and will assume further development of RG-125(AZD4076).

Previous research has demonstrated a causative role of microRNAs in pathophysiological processes of metabolic diseases, and increased expression of miR-103/107 in the liver has been associated with insulin resistance in people with non-alcoholic steatopheatitis (NASH), or fatty liver disease.  In mechanistic studies, RG-125(AZD4076) showed effects on biological pathways implicated in NASH progression.

“RG-125(AZD4076) acts as a novel insulin sensitizer which represents a potential new mechanism to treat patients with metabolic diseases such as type 2 diabetes and NASH,” said Paul Grint, MD, President and Chief Executive Officer of Regulus. “Regulus is pleased to [click to continue…]

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regulus therapeutics logoLA 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…]

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Long-Acting Parenteral Formulation of GSK2878175 Being Developed; Co-Administration with RG-101 May Enable Single Visit Therapy for HCV Patients

regulus therapeutics logoLA 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…]

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regulus therapeutics logoLA 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…]

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Achieves Key ‘Clinical Map Initiative’ Goal for 2015 and Advances Orphan Disease Efforts

regulus therapeutics logoLA 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…]

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A microRNA Therapeutic Targeting microRNA-103/107 for the Treatment of NASH in Patients with Type 2 Diabetes/Pre-Diabetes, Selected as Clinical Candidate by AstraZeneca

April 7, 2015

-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 […]

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MicroRNA Therapeutic in Development Receives Orphan Medicinal Product Designation

March 25, 2015

Regulus Receives Orphan Medicinal Product Designation from the European Commission for RG-012, a microRNA Therapeutic in Development for the Treatment of Alport Syndrome LA JOLLA, Calif., March 25, 2015 /PRNewswire/ — Regulus Therapeutics Inc. (NASDAQ:RGLS), a biopharmaceutical company leading the discovery and development of innovative medicines targeting microRNAs, announced today that the European Commission has granted orphan medicinal […]

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Regulus Aims to Advance microRNA Therapeutics Portfolio and Regulus microMarkersSM Division

January 8, 2015

Regulus Announces Key Goals Under its ‘Clinical Map Initiative’ for 2015 Accelerates RG-101 for HCV with Dual-Track Clinical Development Strategy; Top-Line, Single Dose, 4 mg/kg Results as Well as 2mg/kg Extended Follow Up Results from Ongoing Study to be Reported in Early February 2015 LA JOLLA, Calif., Jan. 8, 2015 /PRNewswire/ — Regulus Therapeutics Inc. (NASDAQ:RGLS), a biopharmaceutical […]

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microRNA-122: Positive Preclinical Profile of a GalNAc-conjugated anti-miR Supports Clinical Development for the Treatment of HCV

November 4, 2013

Regulatory Application for RG-101 to be Filed in the Near Term: Clinical Studies in Man Expected to Commence in Early 2014 LA JOLLA, Calif., Nov. 4, 2013 /PRNewswire/ — Regulus Therapeutics Inc. (NASDAQ: RGLS), a biopharmaceutical company leading the discovery and development of innovative medicines targeting microRNAs, today announced that data demonstrating the positive preclinical profile of […]

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Regulus Provides Update on ‘Road to the Clinic’ Strategy and Reports First Quarter 2013 Financial Results and Recent Highlights

May 14, 2013

– Nominated RG-101 in HCV as First microRNA Candidate for Clinical Development- – Maintained Strong Financial Position with Over $90 million in Cash- LA JOLLA, Calif., May 14, 2013 /PRNewswire/ — Regulus Therapeutics Inc. (NASDAQ: RGLS), a biopharmaceutical company leading the discovery and development of innovative medicines targeting microRNAs, today provided an update on its microRNA […]

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