SAN
DIEGO, June 23, 2023 /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
Preston S. Klassen, M.D., President
and Head of Research & Development, has been appointed to the
Company's Board of Directors.
"We are delighted to have Dr. Klassen join our board during this
exciting time for Regulus, as we advance the clinical development
of RGLS8429 for the treatment of ADPKD," said Stelios Papadopoulos, Ph.D., Chairman of the
Board of Directors of Regulus. "His expertise in nephrology, along
with his previous leadership and board experience in the industry,
will make him an invaluable member, and we look forward to his
contributions to Regulus and our science."
Preston Klassen, M.D., recently
joined Regulus Therapeutics as President and Head of Research and
Development. Dr. Klassen is a nephrologist by training who brings
over 20 years of experience in pharmaceuticals, including positions
in leadership, medical affairs, and research and development across
multiple therapeutic areas. Most recently he served as the
President and CEO of Metacrine. Prior to that, he was an Executive
Vice President and Head of R&D at Arena Pharmaceuticals, CMO
and President at SANIFIT, and Senior Vice President and Head of
Global Development at Orexigen Therapeutics. Previously, while at
Amgen, he held multiple leadership roles, including Executive
Medical Director and Therapeutics Area Head for Nephrology. Dr.
Klassen earned his M.D. from the University of
Nebraska Medical Center and completed both his residency in
internal medicine and fellowship in nephrology as well as his
Master's in Health Sciences at Duke
University Medical Center.
About ADPKD
Autosomal Dominant Polycystic Kidney Disease (ADPKD), caused by
mutations in the PKD1 or PKD2 genes, is among the most common human
monogenic disorders and a leading cause of end-stage renal disease.
The disease is characterized by the development of multiple fluid
filled cysts primarily in the kidneys, and to a lesser extent in
the liver and other organs. Excessive kidney cyst cell
proliferation, a central pathological feature, ultimately leads to
end-stage renal disease in approximately 50% of ADPKD patients by
age 60. Approximately 160,000 individuals are diagnosed with the
disease in the United States
alone, with an estimated global prevalence of 4 to 7 million.
About RGLS8429
RGLS8429 is a novel, next generation oligonucleotide for the
treatment of ADPKD designed to inhibit miR-17 and to preferentially
target the kidney. Administration of RGLS8429 has shown robust data
in preclinical models, where clear improvements in kidney function,
size, and other measures of disease severity have been demonstrated
along with a superior pharmacologic profile in preclinical studies
compared to Regulus' first-generation compound, RGLS4326. Regulus
announced completion of the Phase 1 SAD study in September
2022. The Phase 1 SAD study demonstrated that RGLS8429 has a
favorable safety and PK profile. RGLS8429 was well-tolerated
with no serious adverse events reported and plasma exposure was
approximately linear across the four doses tested and is similar to
the PK data from the first-generation compound. In April, Regulus
announced completion of enrollment for the first cohort of patients
in the Phase 1b MAD study and with
the recent review of all available safety data, is advancing to the
second cohort where patients will receive 2 mg/kg of RGLS8429 or
placebo every other week for three months.
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 Company's RGLS8429
program, including the expected timing for initiating clinical
studies, the expected timing for reporting topline data, the safety
of RGLS8429 potentially achieving therapeutic efficacy and
clinical translation for ADPKD patients and the timing and future
occurrence of other preclinical and clinical activities. 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, the approach we are taking to discover and develop
drugs is novel and may never lead to marketable products,
preliminary or initial results may not be indicative of future
results, preclinical and clinical studies may not be successful,
risks related to regulatory review and approval, risks related to
our reliance on third-party collaborators and other third parties,
risks related to intellectual property, 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, the risk
additional toxicology data may be negative and the need for
additional capital. 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 filed 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.