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 under this clinical
collaboration represents one of many approaches Regulus is actively
pursuing with RG-101. We remain committed to realizing the
full potential of RG-101 and we look forward to initiating the
combination study in the first quarter of 2016."
Zhi Hong, Senior Vice President
and Head of the Infectious Diseases Therapy Area, GSK commented,
"Building on GSK's long-acting formulation expertise and know
how, we are excited about the potential of this combination to
provide people living with HCV a new treatment option that could be
delivered in a single visit."
Regulus will be responsible for conducting a multi-center,
open-label Phase II study to evaluate the potential to achieve
sustained viral responses post treatment with a single subcutaneous
administration of 4 mg/kg of RG-101 in combination with daily oral
administrations of 20 mg of GSK2878175 for up to 12 weeks in
treatment-naive patients chronically infected with HCV genotypes 1
and 3. This study will be conducted outside the United States and is planned to begin in
the first quarter of 2016. Neither Regulus nor GSK has any
further obligations or commitments beyond the contemplated study
under the clinical collaboration agreement.
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. Under its 'Clinical Map Initiative', 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 been selected for clinical
development. 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 and a research collaboration with
Biogen focused on microRNA biomarkers. 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.
Logo - http://photos.prnewswire.com/prnh/20150130/172637LOGO
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/regulus-expands-development-of-rg-101-through-clinical-trial-collaboration-with-gsk-300170807.html
SOURCE Regulus Therapeutics Inc.