LA JOLLA, Calif., March 16, 2016 /PRNewswire/ -- Regulus
Therapeutics Inc. (NASDAQ: RGLS), a biopharmaceutical company
leading the discovery and development of innovative medicines
targeting microRNAs, today announced that new data on RG-101, the
company's anti-miR-122 in Phase II development for the treatment of
Hepatitis C Virus infection (HCV), will be presented as an oral
presentation during the general session at The International Liver
Congress™ (ILC) 2016, April 13-17 in
Barcelona, Spain. Three poster
presentations outlining additional RG-101 clinical and preclinical
research will also be included as part of the meeting's poster
sessions.
"Regulus and our clinical investigators are pleased to be making
several presentations at this year's International Liver Congress,
including an oral presentation during the general session
elaborating on recent interim results from an ongoing Phase II
combination study of RG-101 for the treatment of HCV," said
Paul Grint, M.D., President and
Chief Executive Officer of Regulus. "We believe the work presented
further supports our novel approach to treating HCV as well as the
clinical utility of RG-101 within the HCV landscape."
Oral Presentation
- Friday, April 15, 8:45am CET (General Session): RG-101 in
Combination with 4 Weeks of Oral Direct Acting Antiviral Therapy
Achieves High Virologic Response Rates in Treatment Naïve Genotype
1 and 4 Chronic Hepatitis C Patients: Interim Results from a
Randomised, Multi-Center, Phase 2 Study (G. Horvath, Hungary).
Poster Presentations
- Abstract THU-254: A Single Dose of Anti-miR-122
Oligonucleotide RG-101 Results in a Less Activated Phenotype of NK
Cells in Patients with Chronic Hepatitis C (F. Stelma, Netherlands).
- Abstract THU-232: Sequence Analysis for Resistance
Monitoring Following A Single Dose of RG-101, an anti-miR Targeting
microRNA-122, in Chronic Hepatitis C Patients (M. van der Ree, Netherlands).
- Abstract THU-239: RG-101 Demonstrates Favorable in Vitro
Antiviral Activity and Cross Resistance Profile to Support Clinical
Combination in HCV Patients (S. Neben, United States).
When available, the abstracts related to the presentations can
be accessed through the ILC/EASL website at ilc-congress.eu.
About RG-101 for HCV
RG-101 is Regulus' wholly-owned, GalNAc-conjugated anti-miR
targeting miR-122 for the treatment of HCV. In a completed Phase I
human proof-of-concept study, Regulus demonstrated that treatment
with a single subcutaneous dose of RG-101 as monotherapy resulted
in significant and sustained viral load reductions in all treated
HCV patients, including patients with difficult to treat genotypes,
various liver fibrosis status and those who have experienced viral
relapse after a prior IFN-containing regimen.
Recently, Regulus presented favorable interim data from an
ongoing Phase II study evaluating the combination of RG-101 with
multiple approved DAAs positioning RG-101 for both front-line and
second-line commercial opportunities. Patients received a single
subcutaneous injection of 2 mg/kg of RG-101 on Day 1, followed by
28 days of a once daily oral DAA (Harvoni®, Olysio®, or Daklinza™),
followed by an additional subcutaneous injection of 2 mg/kg of
RG-101 on Day 29. Regulus is planning to report primary
endpoint results at 12 weeks following conclusion of treatment in
late Q2 2016.
In collaboration with GSK, Regulus recently initiated 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.
Additionally, enrollment is nearly complete in a multi-center, open
label, non-randomized Phase I study to compare the safety,
tolerability, pharmacokinetics, and pharmacodynamics of 2 mg/kg of
RG-101 in subjects with severe renal insufficiency or end-stage
renal disease (ESRD) to healthy control subjects, and further
explore RG-101 in hepatitis C infected subjects with severe renal
insufficiency or ESRD. Regulus anticipates reporting safety and
efficacy data from the HCV/severe renal impairment or ESRD arm in
the second half of 2016.
About microRNAs
The discovery of microRNAs in humans during the last decade is
one of the most exciting scientific breakthroughs in recent
history. microRNAs are small RNA molecules, typically 20 to
25 nucleotides in length, that do not encode proteins but instead
regulate gene expression. More than 800 microRNAs have been
identified in the human genome, and over two-thirds of all human
genes are believed to be regulated by microRNAs. A single
microRNA can regulate entire networks of genes. As such, these
molecules are considered master regulators of the human
genome. microRNA expression, or function, has been shown to
be significantly altered or dysregulated in many disease states,
including oncology, fibrosis, metabolic diseases,
immune-inflammatory diseases and HCV. Targeting microRNAs with
anti-miRs, chemically modified, single-stranded oligonucleotides,
offers a unique approach to treating disease by modulating entire
biological pathways and may become a new and major class of drugs
with broad therapeutic application.
About Regulus
Regulus Therapeutics Inc. (NASDAQ: RGLS) is a
biopharmaceutical company leading the discovery and development of
innovative medicines targeting microRNAs. Regulus has
leveraged its oligonucleotide drug discovery and development
expertise to develop a well-balanced microRNA therapeutics pipeline
complemented by a maturing
microMarkersSM biomarkers platform and a rich
intellectual property estate to retain its leadership in the
microRNA field. Regulus is developing RG-101, a
GalNAc-conjugated anti-miR targeting microRNA-122 for the treatment
of chronic hepatitis C virus infection, and RG-012, an anti-miR
targeting microRNA-21 for the treatment of Alport syndrome, a
life-threatening kidney disease driven by genetic mutations with no
approved therapy. In addition, RG-125, a GalNAc-conjugated
anti-miR targeting microRNA-103/107 for the treatment of NASH in
patients with type 2 diabetes/pre-diabetes, has entered Phase I
clinical development through its strategic alliance with
AstraZeneca. Regulus is also advancing several programs
toward clinical development in orphan disease indications, oncology
and fibrosis. Regulus' commitment to innovation has resulted
in multiple peer-reviewed publications in notable scientific
journals and has resulted in the formation of strategic alliances
with AstraZeneca and Sanofi. 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 (including with respect to development and other activities
related to RG-101), the projected timeline of clinical development
activities, and expectations regarding future therapeutic and
commercial potential of Regulus' business plans, technologies and
intellectual property related to microRNA therapeutics and
biomarkers being discovered and developed by Regulus. 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.
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