Regulus to Present Preclinical Efficacy Data Highlighting Potential of Novel Treatment for Nonalcoholic Steatohepatitis at The International Liver Congress™ 2019

Favorable Pharmacological Properties Exhibited in Preclinical Models of NASH

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Apr 08, 2019, 08:00 ET

LA JOLLA, Calif., April 8, 2019 /PRNewswire/ -- Regulus Therapeutics Inc. (NASDAQ: RGLS), a biopharmaceutical company focused on the discovery and development of innovative medicines targeting microRNAs, today announced that it will present preclinical data on the therapeutic potential of its lead anti-miR for the treatment of nonalcoholic steatohepatitis (NASH), at the EASL International Liver Congress™ 2019 being held April 10-14, 2019 in Vienna, Austria.

"We are pleased to be presenting preclinical data during this year's EASL International Liver Congress that we believe demonstrates the potential of our lead anti-miR-132 to be a promising therapeutic for the treatment of NASH," said Jay Hagan, President and Chief Executive Officer of Regulus.

Details of the late breaker poster presentation are as follows and will be available for download at the time of presentation at http://regulusrx.com/publications.

Poster Board #LBP-40
Title: "Development of Oligonucleotide-Based miR-132 Antagonists for the Treatment of NASH", Papazyan, R., et al.
Session: Late Breaker Poster session, NAFLD therapy
Poster display date and time: April 11-13, 9:00-18:30

Demonstration of miR-132 upregulation (2 to 4-fold) in liver tissues of NASH patients compared to those of healthy donors.
Demonstration of efficacy in preclinical models of NASH with the Company's lead anti-miR-132. Results showed reduced liver triglyceride levels by up to 50%, neutralized serum liver enzyme levels (ALT and AST), enhanced glucose tolerance, and improved histopathological scores. Therapeutic effects were sustained for up to 6 weeks following the final dose.
Global gene expression profiling revealed significant increase in metabolic genes and a decrease in inflammatory and fibrotic genes.

About NASH

Nonalcoholic steatohepatitis (NASH) is an inflammatory liver disease associated with excessive fat accumulation in the liver which can lead to progressive fibrosis. The prevalence of NASH in the United States is thought to be 3-5% of the general population, with a sizable proportion of the patients having either severe disease or high risk of progression to cirrhosis, liver cancer or liver failure.

About Regulus

Regulus Therapeutics Inc. (Nasdaq: RGLS) is a biopharmaceutical company focused on the discovery and development of innovative medicines targeting microRNAs. Regulus has leveraged its oligonucleotide drug discovery and development expertise to develop a pipeline complemented by a rich intellectual property estate in the microRNA field. Regulus maintains its corporate headquarters in La Jolla, CA. For more information, please visit http://www.regulusrx.com.

Forward-Looking Statements

Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements associated with the expected ability of Regulus to undertake certain activities and accomplish certain goals and objectives (including with respect to development and other activities related to its miR-132 program in NASH). Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as "believes," "anticipates," "plans," "expects," "intends," "will," "goal," "potential" and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Regulus' current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks associated with the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such drugs. These and other risks concerning Regulus' financial position and programs are described in additional detail in Regulus filings with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Regulus undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

SOURCE Regulus Therapeutics Inc.