Appoints Preston S. Klassen, M.D., as
President and Head of Research & Development
Curtis A. Monnig, Ph.D., named Vice
President of CMC
SAN
DIEGO, June 12, 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
the appointment of Preston S. Klassen
M.D., M.H.S., to President and Head of Research and
Development. Dr. Klassen brings over 20 years of experience in
leadership roles in both large and small biopharmaceutical
companies. In addition, the Company announced the appointment of
Curtis A. Monnig, Ph.D., to Vice
President of CMC.
"We are thrilled to welcome Dr. Klassen to the Regulus team,"
said Jay Hagan, Chief Executive
Officer of Regulus Therapeutics. "Preston's considerable leadership
experience across a range of therapeutic areas and modalities is a
huge addition for Regulus and his particular expertise in both
academic and industry settings in the field of kidney disease will
be invaluable as we advance our program in ADPKD."
Dr. Preston Klassen is an
established nephrologist who brings years of experience 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 nephrology as well as his Master's in Health
Sciences at Duke University Medical
Center.
"I'm excited to be joining a team where I will have a hand in
helping to bring novel disease-modifying therapies for kidney and
other orphan diseases through the clinic and to patients in need,"
said Dr. Klassen. "I am particularly looking forward to leading the
team as we advance through the Phase 1b MAD study of RGLS8429 for the treatment of
ADPKD. We look forward to reviewing the topline data from the first
cohort of patients expected later this year and working to advance
the pipeline as we execute on upcoming clinical milestones."
Dr. Curtis Monnig comes to
Regulus with over 25 years of experience in both pharmaceutical and
biotech product development and commercial product support. Most
recently, he was Vice President of CMC at January Therapeutics.
Prior to this, he held positions at Currax Pharmaceuticals,
Allergan, Cardinal Health and Amylin Pharmaceuticals. Dr. Monnig
earned his B.S. in biochemistry and M.S. in chemistry from the
University of Missouri and his Ph.D. in
chemistry from Indiana University.
On June 12, 2023, Dr. Klassen will
be granted (i) a stock option under the Company's 2021 Inducement
Plan to purchase 250,000 shares of the Company's common stock and
(ii) a stock option to purchase 100,000 shares of the Company's
common stock under the Company's 2019 Equity Incentive Plan. Each
of the options will have an exercise price equal to the fair market
value at closing on the date of grant. The option has a 10-year
term and vests over a period of four years, with 25% of the option
vesting on the first anniversary of the Employment Commencement
Date and the balance vesting in equal monthly installments over the
following 36 months, subject to Dr. Klassen's continuous service
through each vesting date, and subject to the terms and conditions
of Regulus' 2021 Inducement Plan, the 2019 Equity Incentive Plan
and the stock option grant notices and agreements thereunder. The
options were granted under Nasdaq Listing Rule 5635(c)(4) as an
inducement material to Dr. Klassen entering into employment with
the Company.
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 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, 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 filed annual 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.