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Regulus Therapeutics: Regulus Reports Third Quarter 2015 Financial Results And Recent Highlights

The following excerpt is from the company's SEC filing.

-Expanded Development of RG-101 through Clinical Trial Collaboration with GSK to

Achieve Potential Single Visit HCV Therapy -

-Maintained Strong Financial Position Ending Q3 2015 with $131.7 Million in Cash-

LA JOLLA, Calif., November 5, 2015

Regulus Therapeutics Inc


), a biopharmaceutical company leading the discovery and development of innovative medicines targeting microRNAs, today reported financial results and highlights for the quarter ended September 30, 2015 and provided a summary of recent corporate highlights.

Regulus recent achievements reflect our steady progress in building a meaningful clinical portfolio based on microRNAs, said Paul Grint, M.D., President and CEO of Regulus. Specifically, we expanded development of RG-101, advanced RG-012 through Phase I, and realized the full economic value of our biomarkers collaboration with Biogen. In the coming months, we look forward to presenting data on our programs at key medical meetings and continuing to execute on our plans.

Third Quarter 2015 and Recent Highlights

RG-101 Highlights

Entered Into Clinical Trial Collaboration Agreement with GlaxoSmithKline (GSK) to Evaluate HCV Combination Regimen.

In the first quarter of 2016, Regulus plans to initiate a Phase II study evaluating the combination of RG-101 and GSK2878175, a non-nucleoside NS5B polymerase inhibitor, in treatment-naïve patients chronically infected with HCV genotypes 1 and 3. Concurrently, GSK will work on developing a long-acting parenteral formulation for injection (LAP) 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.

Announced Additional Data to be Presented at The Liver Meeting

During a general plenary session at The Liver Meeting

, the 66

Annual Meeting of the American Association for the Study of Liver Disease (AASLD), Regulus investigators will present extended follow-up results from the Phase I clinical study of RG-101. In a poster presentation, Regulus investigators will present preclinical data examining immunological changes observed in plasma of the HCV patients dosed in the Phase I study.

Initiated Phase II Combination Study; Interim Data in Early 2016.

In August, Regulus initiated a Phase II study evaluating the efficacy of RG-101 when given in combination with

marketed anti-HCV agents Harvoni

, Olysio

, and Daklinza

for 28 days. Regulus announced today that it expects to report interim data from this study in early 2016 and sustained viral response data 12 weeks following conclusion of treatment (SVR12) in the second quarter of 2016.

RG-012 Highlights

Announced Preclinical Data to be Presented at Kidney Week, Nov. 3-8, 2015.

During a poster presentation at the American Society of Nephrologys (ASN) Kidney Week, Regulus will present preclinical results demonstrating the favorable pharmacokinetic and toxicokinetic properties of RG-012, an anti-miR targeting microRNA-21 (miR-21) for the treatment of Alport syndrome, a life threatening disease with no approved therapy. In addition, Regulus will present results describing a novel methodology to assess inhibition of miR-21, and Regulus microMarkers

will present data highlighting the discovery of urine microRNA biomarkers in a preclinical model of Alport Nephropathy.

Completed First-In-Human Phase I Study of RG-012.

Regulus announced today that the Phase I study evaluating the safety, tolerability and pharmacokinetics of subcutaneous dosing of RG-012 in healthy volunteers is complete. Forty healthy volunteer subjects were enrolled in this first-in-human, single ascending dose study. RG-012 was well-tolerated and no serious adverse events were reported. In the first half of 2016, Regulus plans to initiate a Phase II proof-of-concept study evaluating the efficacy of RG-012 in Alport syndrome patients.