LA JOLLA, Calif., June 1, 2016 /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 its
clinical trial collaboration agreement with GSK (NYSE: GSK) for the
development of RG-101, Regulus' wholly-owned, GalNAc-conjugated
anti-miR that targets miR-122. In the expanded collaboration,
the companies plan to conduct a multi-centered, randomized,
dose-ranging Phase II study evaluating the combination of RG-101
and GSK's long-acting parenteral ("LAP") formulation of GSK2878175
as a potential single-visit cure in patients chronically infected
with HCV. This study will be conducted outside the United States and is planned to begin in
the fourth quarter of 2016. Based on predicted enrollment
rates, interim results from this expanded collaboration should be
available in the second half of 2017, enabling a potential
initiation of a pivotal study in late 2017. As with the
initial collaboration, both parties will share equally in the costs
associated with the study. Neither Regulus nor GSK has any
further obligations or commitments to each other beyond this
expanded clinical collaboration agreement.
"We are very pleased to expand our working collaboration with
GSK. This is an important next step to advance the scientific
understanding of the potential for a combination therapy to achieve
a single-visit cure for HCV," said Paul
Grint, M.D., President and CEO of Regulus. "The market
research conducted to date indicates that a potential single visit
cure would be a highly preferred product profile to existing
regimens."
Zhi Hong, Senior Vice President
and Head of the Infectious Diseases Therapy Area, GSK, commented,
"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. Together with Regulus, we are taking
another step forward to proving this novel concept."
Earlier this year, pursuant to the initial GSK-Regulus clinical
trial collaboration agreement, Regulus began enrolling patients in
an open-label Phase II clinical trial combining RG-101 and
GSK2878175 for the treatment of HCV 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-naïve patients chronically infected with HCV
genotypes 1 and 3. Regulus and GSK anticipate reporting
interim results from this study by year-end.
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 renal, hepatic and central nervous
systems diseases, both independently and with our strategic
alliance partners, Sanofi and AstraZeneca. 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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SOURCE Regulus Therapeutics Inc.