SAN DIEGO, Feb. 24, 2022 /PRNewswire/ -- Regulus
Therapeutics Inc. (Nasdaq: RGLS), a biopharmaceutical company
focused on the discovery and development of innovative medicines
targeting microRNAs (the "Company" or "Regulus"), today announced
the completion of enrollment in the Phase 2 HERA clinical study
evaluating lademirsen (RG-012) for the treatment of adult patients
with Alport Syndrome under the Company's Collaboration and License
Agreement with Sanofi.
"We value our collaboration with Sanofi and continue to be proud
of the steady progress being made not only in this study, but also
in our technology to treat kidney disease," said Jay Hagan, President and Chief Executive Officer
of Regulus Therapeutics. "With final data for this Phase 2 trial
expected in the first half of next year, this study is a critical
step in our effort to improve the lives of patients suffering from
Alport Syndrome, a life-threatening, genetic rare nephrology
disease for which there are no currently available treatments."
Lademirsen is a single stranded, chemically modified
oligonucleotide that binds to and inhibits the function of miR-21.
Initiated in September 2017, the HERA
study is a global, randomized, placebo-controlled Phase 2 study
designed to assess the safety and tolerability of lademirsen, as
well as the efficacy in reducing the decline in renal function in
adult patients with Alport Syndrome. The Company expects HERA
results in the first half of 2023.
In 2020, Regulus achieved $10
million in milestone payments associated with the completion
of transfer and verification of certain materials as well as an
interim enrollment milestone from Sanofi for its progress with
the HERA study. Under the terms of the Collaboration and
License Agreement, the Company is also eligible to receive an
additional $25 million upon successful completion of the
ongoing HERA study.
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 San Diego, CA.
Forward-Looking Statements
Statements contained in this presentation 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 collaboration with
Sanofi including the potential completion of studies concerning
lademirsen and receipt of milestones by Regulus therefrom. 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, and the risk additional toxicology data may be negative. In
addition, while Regulus expects the COVID-19 pandemic to adversely
affect its business operations and financial results, the extent of
the impact on Regulus' ability to achieve its preclinical and
clinical development objectives and the value of and market for its
common stock, will depend on future developments that are highly
uncertain and cannot be predicted with confidence at this time,
such as the ultimate duration of the pandemic, travel restrictions,
quarantines, social distancing and business closure requirements in
the U.S. and in other countries, and the effectiveness of
actions taken globally to contain and treat the disease. These and
other risks are described in additional detail in Regulus' filings
with the Securities and Exchange Commission, including under
the "Risk Factors" heading of Regulus most recently quarterly
report on Form 10-Q. 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.